Non-Small Cell Lung Cancer
Conditions
Keywords
ALK+, ROS1
Brief summary
Prospective observational study to IDEntify patients with advanced/metastatic NSCLC and ALK and ROS1 translocation and to establish their therapeutic management (IDEALK&ROS)
Interventions
DRUGCrizotinib
Treatment with crizotinib following routine clinical practice
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For ALK Incidence substudy * Patients with Advanced or metastatic non-small cell lung cancer * Patients who will be screened for anaplastic lymphoma kinase (ALK) rearrangement * Age \> 18 years For ALK treatment substudy (retrospective and prospective) * Age \> 18 years * Confirmed anaplastic lymphoma kinase (ALK)-positive tumour * Patients treated with crizotinib under routine clinical practice * Patients with a minimum data registered at the medical history * For the patients that will be recruited prospectively: Patients must have a signed informed consent document. For the ROS1 treatment sub-study (retrospective only): * Age \> 18 years * Confirmation of NSCLC with ROS1-positive translocation * Have been eligible to receive treatment with crizotinib according to routine clinical practice since the market launch of the ROS1 indication in Spain on 8 February 2017 until the opening of the site. * Patients should have a predetermined minimum amount of data recorded in their medical records.
Exclusion criteria
* Any patient who does not meet any of the inclusion criteria defined in the previous section, depending on the sub-study for which they are included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease) | ECOG quality of life score is a rating of a participant's disease status, daily living activities and quality of life, where 0: fully active, 1: restricted in physically strenuous activity, 2: ambulatory and capable of self-care but unable to work, 3: capable only of limited self-care , 4: completely disabled; cannot carry on any self-care; totally confined to bed or chair, 5: dead. Higher scores indicated more severe disease, difficulty in performing daily activity and poor quality of life. Number of participants classified according to ECOG quality of life scores were reported in this outcome measure. |
| Number of Participants Classified According to the Origin of Tumor Sample | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis) | Number of participants classified according to the origin of tumor sample (primary tumor or metastasis) were reported in this outcome measure. |
| Number of Participants Classified According to Type of Sample Collected for Tumor Analysis | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis) | Number of participants classified according to the type of sample collected (biopsy, cell block or cytology) were reported in this outcome measure. |
| Number of Participants Classified According to Histological Subtype of Tumor | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of diagnosis of ALK and ROS1 metastatic disease) | Number of participants classified according to the histological subtype (adenocarcinoma, squamous, large cell, not otherwise specified \[NOS\], other) were reported in this outcome measure. |
| Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis of metastatic disease) | Tumor Node Metastasis (TNM): based on tumor size, metastasis to nearby lymph nodes (LN), or distant metastasis. Stages were: stage IIIA (T0N2M0, T1N2M0,T2N3M0, T3N1 or N2M0), stage IIIB (T4 any NM0, any TN3M0), stage IV (any T any NM1), where T0 = early form of tumor, T1 = less than (\<) 2 centimeter (cm), T2 = 2-5 cm, T3 = greater than (\>) 5 cm, T4 = large sized, N0 = not spread to lymph nodes (LN), N1 = spread to 1 to 3 LN, N2 = spread to 4 to 9 LN, N3 = spread \>10 axillary LN, M0 = no metastasis, M1 = metastasis. The number of participants classified according to stages of tumor (Stage IIIA, IIIB and IV) were reported in this outcome measure. |
| Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease) | Number of participants classified according to molecular alterations (PD-L1+: programmed death-ligand 1 positive, MET+: mesenchymal epithelial transition factor receptor positive, TP53+: tumor protein 53 positive, AKT: serine/threonine-protein kinase) in tumors were reported in this outcome measure. |
| Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease) | Number of participants classified according to the location of metastases were reported in this outcome measure. One participant may have more than one site of metastases. |
| Number of Participants Categorized According to Number of Treatments Prior to Crizotinib: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | At baseline (for ALK treatment sub-study: after initial diagnosis of ALK metastatic disease; for ROS1 treatment sub-study: after initial diagnosis of ROS1 metastatic disease) | Number of participants classified according to number of treatments (1 or 2) prior to crizotinib were reported in this outcome measure. |
| Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | From date of inclusion until last date of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) | Number of participants with treatment response as complete response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis), partial response (PR): at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), progressive disease (PD): at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were reported in this outcome measure. |
| Number of Participants Classified According to Survival Data: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | From date of inclusion until last date of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) | The number of participants classified as dead or alive were reported in this outcome measure. |
| Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months) | QLQ-C30: 30 item questionnaire consisted of a global health (GH) score, 5 functional domains, 8 symptom scales and single item about financial difficulties. All items were graded by severity experienced during previous week and used a 4-point-scale (1: not at all, 2: a little, 3: quite a bit, 4: very much). The scores were converted to health-related quality of life (HRQoL) scale ranging from 0 - 100. Higher GH and functional domain scores indicated better function and lower scores in symptom scales and single item indicated more severity. Positive changes from baseline indicated improvement and negative changes from baseline indicated worsening for GH and functional domains. Negative changes from baseline indicated improvement and higher levels of functioning and positive changes from baseline indicated worsening for symptom scale and single item. Stable indicated that the symptoms were neither improving nor worsening. |
| Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months) | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer & treatment side effects typical of treatment with chemotherapy and radiotherapy. It comprised of multi-item scale and single-item scale for symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, & medicine for pain). Response range - 1: Not at all to 4: Very much. The scores were converted to a HRQoL scale ranging from 0 - 100 where, higher scores = greater level of symptoms. Negative changes from baseline indicated improvement and positive changes from baseline indicated worsening. Stable indicated that the symptoms were neither improving nor deteriorating. |
| Percentage of Participants With Anaplastic Lymphoma Kinase Positive Translocations: ALK Incidence Sub-Study | At baseline (after initial diagnosis of lung cancer and until end of recruitment of ALK incidence sub study) | The percentage of participants with ALK positive translocations were reported in this outcome measure. |
| Progression-Free Survival (PFS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study | From first day of treatment until date of progressive disease, death or censored, whichever was the earliest (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) | Progression-free survival (PFS) was defined as the period between the first day of treatment and the first day that progressive disease (PD) (at least a 20% increase \[including an absolute increase of at least 5 mm\] in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions) was observed according to response evaluation criteria in solid tumors (RECIST) criteria, or death. Participants who have not had an event at the time of the analysis of the study data were censored at the date of the last available follow-up. |
| Objective Response Rate (ORR): ALK Treatment Sub-study and ROS1 Treatment Sub-Study | From first day of treatment until date of CR, PR or SD (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) | ORR: percentage of participants who achieved CR : disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size(\<10 mm short axis), or PR : at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Additionally, the participants with SD : neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. The participants were evaluated in accordance with RECIST criteria. |
| Duration of Response (DOR): ALK Treatment Sub-study and ROS1 Sub-Study | From the date the best response was documented until the date of progressive disease (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) | Duration of response (DOR) in participants with PR or CR was defined as the interval from the date the best response was documented to the first date that progressive disease (at least a 20% increase \[including an absolute increase of at least 5 mm\] in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions) was observed. |
| Overall Survival (OS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study | From first day of treatment until date of death or censored, whichever was earliest (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) | Overall survival (OS) was defined as the period from the first day of treatment until death or censored up to the last date on which it was known that the participant was alive. |
| Number of Participants With Adverse Events According to Seriousness: ALK Treatment Sub-study and ROS1 Treatment Sub-Study | From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. SAE was defined as any untoward medical occurrence at any dose that: resulted in death, was life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required hospitalization or prolongation of existing hospitalization. The number of participants with non-SAEs and SAEs were reported in this outcome measure. |
Countries
Spain
Participant flow
Pre-assignment details
Participants with advanced/metastatic non-small cell lung cancer (NSCLC) were recruited in this multicentre, observational post-authorisation study. Participants were included in 3 sub-studies: ALK incidence, ALK treatment and ROS1 treatment sub-study. A total of 692 participants were enrolled in the study (ALK incidence sub-study= 572, ALK treatment sub-study=70 participants excluding 21 participants who were included from ALK incidence sub-study and ROS1 sub-study: 50).
Participants by arm
| Arm | Count |
|---|---|
| ALK Incidence Sub-study All participants with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) diagnosed at the hospital and who underwent Anaplastic Lymphoma Kinase (ALK) translocation molecular testing subsequently were included in the incidence sub-study. | 559 |
| ALK Treatment Sub-study Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included. | 70 |
| ROS1 Treatment Sub-study Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included. | 50 |
| Total | 679 |
Baseline characteristics
| Characteristic | ALK Incidence Sub-study | ALK Treatment Sub-study | ROS1 Treatment Sub-study | Total |
|---|---|---|---|---|
| Age, Customized 20 to 90 years | 559 Participants | 70 Participants | 50 Participants | 679 Participants |
| Number of Participants Classified According to Smoking Status Former-smoker | 256 Participants | 17 Participants | 17 Participants | 290 Participants |
| Number of Participants Classified According to Smoking Status Non-smoker | 89 Participants | 38 Participants | 24 Participants | 151 Participants |
| Number of Participants Classified According to Smoking Status Smoker | 214 Participants | 15 Participants | 9 Participants | 238 Participants |
| Previous Relevant Medical History: ALK Treatment Sub-study and ROS1 Sub-study Cardiovascular disease | 0 Participants | 18 Participants | 35 Participants | 53 Participants |
| Previous Relevant Medical History: ALK Treatment Sub-study and ROS1 Sub-study Gastrointestinal disorders | 0 Participants | 6 Participants | 6 Participants | 12 Participants |
| Previous Relevant Medical History: ALK Treatment Sub-study and ROS1 Sub-study Neoplasm diseases | 0 Participants | 6 Participants | 10 Participants | 16 Participants |
| Previous Relevant Medical History: ALK Treatment Sub-study and ROS1 Sub-study Other | 0 Participants | 19 Participants | 22 Participants | 41 Participants |
| Previous Relevant Medical History: ALK Treatment Sub-study and ROS1 Sub-study Pulmonary diseases | 0 Participants | 4 Participants | 4 Participants | 8 Participants |
| Previous Relevant Medical History: ALK Treatment Sub-study and ROS1 Sub-study Surgery | 0 Participants | 23 Participants | 22 Participants | 45 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 195 Participants | 45 Participants | 28 Participants | 268 Participants |
| Sex: Female, Male Male | 364 Participants | 25 Participants | 22 Participants | 411 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 38 / 91 | 25 / 50 |
| other Total, other adverse events | 54 / 91 | 33 / 50 |
| serious Total, serious adverse events | 25 / 91 | 9 / 50 |
Outcome results
Primary
Duration of Response (DOR): ALK Treatment Sub-study and ROS1 Sub-Study
Duration of response (DOR) in participants with PR or CR was defined as the interval from the date the best response was documented to the first date that progressive disease (at least a 20% increase \[including an absolute increase of at least 5 mm\] in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions) was observed.
Time frame: From the date the best response was documented until the date of progressive disease (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
Population: ALK treatment sub-study: all participants with confirmed ALK-positive translocation and who received treatment with crizotinib.ROS1 treatment sub-study: all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.Here,'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ALK Treatment Sub-study | Duration of Response (DOR): ALK Treatment Sub-study and ROS1 Sub-Study | 13.5 Months |
| ROS1 Treatment Sub-study | Duration of Response (DOR): ALK Treatment Sub-study and ROS1 Sub-Study | 4.4 Months |
Primary
Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only
ECOG quality of life score is a rating of a participant's disease status, daily living activities and quality of life, where 0: fully active, 1: restricted in physically strenuous activity, 2: ambulatory and capable of self-care but unable to work, 3: capable only of limited self-care , 4: completely disabled; cannot carry on any self-care; totally confined to bed or chair, 5: dead. Higher scores indicated more severe disease, difficulty in performing daily activity and poor quality of life. Number of participants classified according to ECOG quality of life scores were reported in this outcome measure.
Time frame: At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease)
Population: ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALK Treatment Sub-study | Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | 0 | 35 Participants |
| ALK Treatment Sub-study | Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | 1 | 43 Participants |
| ALK Treatment Sub-study | Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | 2 | 2 Participants |
| ALK Treatment Sub-study | Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | 3 | 1 Participants |
| ALK Treatment Sub-study | Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | 4 | 0 Participants |
| ALK Treatment Sub-study | Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | 5 | 0 Participants |
| ROS1 Treatment Sub-study | Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | 4 | 0 Participants |
| ROS1 Treatment Sub-study | Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | 0 | 11 Participants |
| ROS1 Treatment Sub-study | Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | 3 | 0 Participants |
| ROS1 Treatment Sub-study | Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | 1 | 29 Participants |
| ROS1 Treatment Sub-study | Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | 5 | 0 Participants |
| ROS1 Treatment Sub-study | Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | 2 | 2 Participants |
Primary
Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
Number of participants with treatment response as complete response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis), partial response (PR): at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), progressive disease (PD): at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were reported in this outcome measure.
Time frame: From date of inclusion until last date of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
Population: ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALK Treatment Sub-study | Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | SD | 22 Participants |
| ALK Treatment Sub-study | Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Unknown | 1 Participants |
| ALK Treatment Sub-study | Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | PD | 11 Participants |
| ALK Treatment Sub-study | Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Not specified/ Not evaluable | 9 Participants |
| ALK Treatment Sub-study | Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | PR | 40 Participants |
| ALK Treatment Sub-study | Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | CR | 8 Participants |
| ROS1 Treatment Sub-study | Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Unknown | 3 Participants |
| ROS1 Treatment Sub-study | Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | CR | 2 Participants |
| ROS1 Treatment Sub-study | Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | PR | 20 Participants |
| ROS1 Treatment Sub-study | Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | SD | 12 Participants |
| ROS1 Treatment Sub-study | Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Not specified/ Not evaluable | 2 Participants |
| ROS1 Treatment Sub-study | Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | PD | 11 Participants |
Primary
Number of Participants Categorized According to Number of Treatments Prior to Crizotinib: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
Number of participants classified according to number of treatments (1 or 2) prior to crizotinib were reported in this outcome measure.
Time frame: At baseline (for ALK treatment sub-study: after initial diagnosis of ALK metastatic disease; for ROS1 treatment sub-study: after initial diagnosis of ROS1 metastatic disease)
Population: ALK treatment sub-study: all participants with confirmed ALK-positive translocation and who received treatment with crizotinib.ROS1 treatment sub-study: all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.Here,'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALK Treatment Sub-study | Number of Participants Categorized According to Number of Treatments Prior to Crizotinib: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | 1 prior treatment | 35 Participants |
| ALK Treatment Sub-study | Number of Participants Categorized According to Number of Treatments Prior to Crizotinib: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | 2 prior treatments | 16 Participants |
| ROS1 Treatment Sub-study | Number of Participants Categorized According to Number of Treatments Prior to Crizotinib: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | 2 prior treatments | 5 Participants |
| ROS1 Treatment Sub-study | Number of Participants Categorized According to Number of Treatments Prior to Crizotinib: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | 1 prior treatment | 14 Participants |
Primary
Number of Participants Classified According to Histological Subtype of Tumor
Number of participants classified according to the histological subtype (adenocarcinoma, squamous, large cell, not otherwise specified \[NOS\], other) were reported in this outcome measure.
Time frame: At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of diagnosis of ALK and ROS1 metastatic disease)
Population: For ALK incidence sub-study, analysis population included all participants who presented an evaluable test for ALK translocation. For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALK Treatment Sub-study | Number of Participants Classified According to Histological Subtype of Tumor | Squamous | 71 Participants |
| ALK Treatment Sub-study | Number of Participants Classified According to Histological Subtype of Tumor | NOS | 16 Participants |
| ALK Treatment Sub-study | Number of Participants Classified According to Histological Subtype of Tumor | Adenocarcinoma | 453 Participants |
| ALK Treatment Sub-study | Number of Participants Classified According to Histological Subtype of Tumor | Large Cell | 19 Participants |
| ALK Treatment Sub-study | Number of Participants Classified According to Histological Subtype of Tumor | Other | 0 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Histological Subtype of Tumor | Large Cell | 3 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Histological Subtype of Tumor | NOS | 2 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Histological Subtype of Tumor | Other | 1 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Histological Subtype of Tumor | Squamous | 1 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Histological Subtype of Tumor | Adenocarcinoma | 84 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Histological Subtype of Tumor | Other | 0 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Histological Subtype of Tumor | Adenocarcinoma | 44 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Histological Subtype of Tumor | Squamous | 2 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Histological Subtype of Tumor | Large Cell | 1 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Histological Subtype of Tumor | NOS | 3 Participants |
Primary
Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
Number of participants classified according to the location of metastases were reported in this outcome measure. One participant may have more than one site of metastases.
Time frame: At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease)
Population: ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALK Treatment Sub-study | Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Lymph nodes | 30 Participants |
| ALK Treatment Sub-study | Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Lung/Pleura | 42 Participants |
| ALK Treatment Sub-study | Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Bone | 34 Participants |
| ALK Treatment Sub-study | Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Brain | 11 Participants |
| ALK Treatment Sub-study | Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Liver | 12 Participants |
| ALK Treatment Sub-study | Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Other | 14 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Liver | 7 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Lymph nodes | 16 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Brain | 4 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Lung/Pleura | 18 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Other | 22 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Bone | 14 Participants |
Primary
Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
Number of participants classified according to molecular alterations (PD-L1+: programmed death-ligand 1 positive, MET+: mesenchymal epithelial transition factor receptor positive, TP53+: tumor protein 53 positive, AKT: serine/threonine-protein kinase) in tumors were reported in this outcome measure.
Time frame: At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease)
Population: ALK treatment sub-study: all participants with confirmed ALK-positive translocation and who received treatment with crizotinib.ROS1 treatment sub-study: all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.Here,'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALK Treatment Sub-study | Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | PD-L1+ | 4 Participants |
| ALK Treatment Sub-study | Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | TP53+ | 1 Participants |
| ALK Treatment Sub-study | Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | AKT | 0 Participants |
| ALK Treatment Sub-study | Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | MET | 0 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | MET | 1 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | PD-L1+ | 14 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | AKT | 1 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | TP53+ | 0 Participants |
Primary
Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study
Tumor Node Metastasis (TNM): based on tumor size, metastasis to nearby lymph nodes (LN), or distant metastasis. Stages were: stage IIIA (T0N2M0, T1N2M0,T2N3M0, T3N1 or N2M0), stage IIIB (T4 any NM0, any TN3M0), stage IV (any T any NM1), where T0 = early form of tumor, T1 = less than (\<) 2 centimeter (cm), T2 = 2-5 cm, T3 = greater than (\>) 5 cm, T4 = large sized, N0 = not spread to lymph nodes (LN), N1 = spread to 1 to 3 LN, N2 = spread to 4 to 9 LN, N3 = spread \>10 axillary LN, M0 = no metastasis, M1 = metastasis. The number of participants classified according to stages of tumor (Stage IIIA, IIIB and IV) were reported in this outcome measure.
Time frame: At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis of metastatic disease)
Population: ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALK Treatment Sub-study | Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study | Stage IV | 78 Participants |
| ALK Treatment Sub-study | Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study | Stage IIIA | 5 Participants |
| ALK Treatment Sub-study | Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study | Stage IIIB | 8 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study | Stage IIIA | 1 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study | Stage IIIB | 7 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study | Stage IV | 42 Participants |
Primary
Number of Participants Classified According to Survival Data: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
The number of participants classified as dead or alive were reported in this outcome measure.
Time frame: From date of inclusion until last date of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
Population: ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALK Treatment Sub-study | Number of Participants Classified According to Survival Data: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Dead | 38 Participants |
| ALK Treatment Sub-study | Number of Participants Classified According to Survival Data: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Alive | 53 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Survival Data: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Dead | 25 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Survival Data: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Alive | 25 Participants |
Primary
Number of Participants Classified According to the Origin of Tumor Sample
Number of participants classified according to the origin of tumor sample (primary tumor or metastasis) were reported in this outcome measure.
Time frame: At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis)
Population: For ALK incidence sub-study, analysis population included all participants who presented an evaluable test for ALK translocation. For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALK Treatment Sub-study | Number of Participants Classified According to the Origin of Tumor Sample | Primary tumor | 409 Participants |
| ALK Treatment Sub-study | Number of Participants Classified According to the Origin of Tumor Sample | Metastases | 150 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to the Origin of Tumor Sample | Primary tumor | 63 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to the Origin of Tumor Sample | Metastases | 28 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to the Origin of Tumor Sample | Primary tumor | 28 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to the Origin of Tumor Sample | Metastases | 22 Participants |
Primary
Number of Participants Classified According to Type of Sample Collected for Tumor Analysis
Number of participants classified according to the type of sample collected (biopsy, cell block or cytology) were reported in this outcome measure.
Time frame: At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis)
Population: For ALK incidence sub-study, analysis population included all participants who presented an evaluable test for ALK translocation. For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALK Treatment Sub-study | Number of Participants Classified According to Type of Sample Collected for Tumor Analysis | Cell Block | 27 Participants |
| ALK Treatment Sub-study | Number of Participants Classified According to Type of Sample Collected for Tumor Analysis | Biopsy | 466 Participants |
| ALK Treatment Sub-study | Number of Participants Classified According to Type of Sample Collected for Tumor Analysis | Cytology | 66 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Type of Sample Collected for Tumor Analysis | Cell Block | 1 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Type of Sample Collected for Tumor Analysis | Biopsy | 75 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Type of Sample Collected for Tumor Analysis | Cytology | 15 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Type of Sample Collected for Tumor Analysis | Biopsy | 40 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Type of Sample Collected for Tumor Analysis | Cytology | 5 Participants |
| ROS1 Treatment Sub-study | Number of Participants Classified According to Type of Sample Collected for Tumor Analysis | Cell Block | 5 Participants |
Primary
Number of Participants With Adverse Events According to Seriousness: ALK Treatment Sub-study and ROS1 Treatment Sub-Study
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. SAE was defined as any untoward medical occurrence at any dose that: resulted in death, was life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required hospitalization or prolongation of existing hospitalization. The number of participants with non-SAEs and SAEs were reported in this outcome measure.
Time frame: From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
Population: Safety population included all participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all the study screening criteria and had received at least one dose of treatment with crizotinib.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALK Treatment Sub-study | Number of Participants With Adverse Events According to Seriousness: ALK Treatment Sub-study and ROS1 Treatment Sub-Study | Non-SAEs | 54 Participants |
| ALK Treatment Sub-study | Number of Participants With Adverse Events According to Seriousness: ALK Treatment Sub-study and ROS1 Treatment Sub-Study | SAEs | 25 Participants |
| ROS1 Treatment Sub-study | Number of Participants With Adverse Events According to Seriousness: ALK Treatment Sub-study and ROS1 Treatment Sub-Study | Non-SAEs | 33 Participants |
| ROS1 Treatment Sub-study | Number of Participants With Adverse Events According to Seriousness: ALK Treatment Sub-study and ROS1 Treatment Sub-Study | SAEs | 9 Participants |
Primary
Objective Response Rate (ORR): ALK Treatment Sub-study and ROS1 Treatment Sub-Study
ORR: percentage of participants who achieved CR : disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size(\<10 mm short axis), or PR : at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Additionally, the participants with SD : neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. The participants were evaluated in accordance with RECIST criteria.
Time frame: From first day of treatment until date of CR, PR or SD (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
Population: ALK treatment sub-study: all participants with confirmed ALK-positive translocation and who received treatment with crizotinib.ROS1 treatment sub-study: all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.Here,'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ALK Treatment Sub-study | Objective Response Rate (ORR): ALK Treatment Sub-study and ROS1 Treatment Sub-Study | 59.3 Percentage of participants |
| ROS1 Treatment Sub-study | Objective Response Rate (ORR): ALK Treatment Sub-study and ROS1 Treatment Sub-Study | 48.9 Percentage of participants |
Primary
Overall Survival (OS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study
Overall survival (OS) was defined as the period from the first day of treatment until death or censored up to the last date on which it was known that the participant was alive.
Time frame: From first day of treatment until date of death or censored, whichever was earliest (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
Population: For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ALK Treatment Sub-study | Overall Survival (OS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study | 46.5 Months |
| ROS1 Treatment Sub-study | Overall Survival (OS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study | 21.9 Months |
Primary
Percentage of Participants With Anaplastic Lymphoma Kinase Positive Translocations: ALK Incidence Sub-Study
The percentage of participants with ALK positive translocations were reported in this outcome measure.
Time frame: At baseline (after initial diagnosis of lung cancer and until end of recruitment of ALK incidence sub study)
Population: Analysis population included all participants presented an evaluable test for ALK translocation. This outcome measure was planned to be analyzed for ALK incidence sub-study only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ALK Treatment Sub-study | Percentage of Participants With Anaplastic Lymphoma Kinase Positive Translocations: ALK Incidence Sub-Study | 31 Participants |
Primary
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
QLQ-C30: 30 item questionnaire consisted of a global health (GH) score, 5 functional domains, 8 symptom scales and single item about financial difficulties. All items were graded by severity experienced during previous week and used a 4-point-scale (1: not at all, 2: a little, 3: quite a bit, 4: very much). The scores were converted to health-related quality of life (HRQoL) scale ranging from 0 - 100. Higher GH and functional domain scores indicated better function and lower scores in symptom scales and single item indicated more severity. Positive changes from baseline indicated improvement and negative changes from baseline indicated worsening for GH and functional domains. Negative changes from baseline indicated improvement and higher levels of functioning and positive changes from baseline indicated worsening for symptom scale and single item. Stable indicated that the symptoms were neither improving nor worsening.
Time frame: Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months)
Population: Analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. This outcome measure was planned to be analyzed in ALK treatment sub-study only. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' indicates number of participants evaluable at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Role functioning: Worsening | 8 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Pain: Worsening | 7 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Pain: Worsening | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Dyspnoea: Worsening | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Loss of appetite: Improvement | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Constipation: Worsening | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Diarrhea: Stable | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Global QoL: Improvement | 8 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Global QoL: Stable | 9 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Global QoL: Worsening | 4 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Physical functioning: Improvement | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Physical functioning: Stable | 10 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Physical functioning: Worsening | 10 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Role functioning: Improvement | 7 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Role functioning: Stable | 8 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Emotional functioning: Improvement | 4 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Emotional functioning: Stable | 13 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Emotional functioning: Worsening | 4 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Cognitive functioning: Improvement | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Cognitive functioning: Stable | 13 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Cognitive functioning: Worsening | 7 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Social functioning: Improvement | 4 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Social functioning: Stable | 9 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Social functioning: Worsening | 8 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Fatigue: Improvement | 9 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Fatigue: Stable | 6 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Fatigue: Worsening | 8 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Nausea and vomiting: Improvement | 8 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Nausea and vomiting: Stable | 9 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Nausea and vomiting: Worsening | 6 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Pain: Improvement | 6 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Pain: Stable | 10 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Dyspnoea: Improvement | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Dyspnoea: Stable | 13 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Dyspnoea: Worsening | 7 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Insomnia: Improvement | 5 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Insomnia: Stable | 12 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Insomnia: Worsening | 6 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Loss of appetite: Improvement | 5 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Loss of appetite: Stable | 14 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Loss of appetite: Worsening | 4 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Constipation: Improvement | 6 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Constipation: Stable | 10 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Constipation: Worsening | 7 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Diarrhea: Improvement | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Diarrhea: Stable | 14 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Diarrhea: Worsening | 7 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Economic difficulties: Improvement | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Economic difficulties: Stable | 12 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Economic difficulties: Worsening | 6 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Global QoL: Improvement | 6 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Global QoL: Stable | 7 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Global QoL: Worsening | 4 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Physical functioning: Improvement | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Physical functioning: Stable | 10 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Physical functioning: Worsening | 6 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Role functioning: Improvement | 5 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Role functioning: Stable | 7 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Role functioning: Worsening | 4 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Emotional functioning: Improvement | 5 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Emotional functioning: Stable | 7 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Emotional functioning: Worsening | 5 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Cognitive functioning: Improvement | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Cognitive functioning: Stable | 8 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Cognitive functioning: Worsening | 7 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Social functioning: Improvement | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Social functioning: Stable | 9 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Social functioning: Worsening | 5 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Fatigue: Improvement | 6 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Fatigue: Stable | 6 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Fatigue: Worsening | 5 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Nausea and vomiting: Improvement | 4 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Nausea and vomiting: Stable | 10 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Nausea and vomiting: Worsening | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Pain: Improvement | 4 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Pain: Stable | 7 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Pain: Worsening | 6 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Dyspnoea: Improvement | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Dyspnoea: Stable | 7 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Dyspnoea: Worsening | 7 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Insomnia: Improvement | 6 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Insomnia: Stable | 7 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Insomnia: Worsening | 4 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Loss of appetite: Improvement | 5 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Loss of appetite: Stable | 9 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Loss of appetite: Worsening | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Constipation: Improvement | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Constipation: Stable | 9 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Constipation: Worsening | 5 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Diarrhea: Improvement | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Diarrhea: Stable | 14 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Diarrhea: Worsening | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Economic difficulties: Improvement | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Economic difficulties: Stable | 12 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Economic difficulties: Worsening | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Global QoL: Improvement | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Global QoL: Stable | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Global QoL: Worsening | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Physical functioning: Improvement | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Physical functioning: Stable | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Physical functioning: Worsening | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Role functioning: Improvement | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Role functioning: Stable | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Role functioning: Worsening | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Emotional functioning: Improvement | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Emotional functioning: Stable | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Emotional functioning: Worsening | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Cognitive functioning: Improvement | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Cognitive functioning: Stable | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Cognitive functioning: Worsening | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Social functioning: Improvement | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Social functioning: Stable | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Social functioning: Worsening | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Fatigue: Improvement | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Fatigue: Stable | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Fatigue: Worsening | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Nausea and vomiting: Improvement | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Nausea and vomiting: Stable | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Nausea and vomiting: Worsening | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Pain: Improvement | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Pain: Stable | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Dyspnoea: Improvement | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Dyspnoea: Stable | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Insomnia: Improvement | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Insomnia: Stable | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Insomnia: Worsening | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Loss of appetite: Stable | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Loss of appetite: Worsening | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Constipation: Improvement | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Constipation: Stable | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Diarrhea: Improvement | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Diarrhea: Worsening | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Economic difficulties: Improvement | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Economic difficulties: Stable | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Economic difficulties: Worsening | 2 Participants |
Primary
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer & treatment side effects typical of treatment with chemotherapy and radiotherapy. It comprised of multi-item scale and single-item scale for symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, & medicine for pain). Response range - 1: Not at all to 4: Very much. The scores were converted to a HRQoL scale ranging from 0 - 100 where, higher scores = greater level of symptoms. Negative changes from baseline indicated improvement and positive changes from baseline indicated worsening. Stable indicated that the symptoms were neither improving nor deteriorating.
Time frame: Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months)
Population: Analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study only. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' indicates number of participants evaluable at specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Cough: Stable | 11 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Sore mouth: Improvement | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Hemoptysis: Stable | 16 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Sore mouth: Worsening | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Dysphagia: Improvement | 4 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Cough: Worsening | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Hemoptysis: Stable | 5 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Sore mouth: Stable | 5 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Dyspnoea: Improvement | 5 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Dyspnoea: Stable | 9 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Dyspnoea: Worsening | 9 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Cough: Improvement | 8 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Cough: Worsening | 5 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Hemoptysis: Improvement | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Hemoptysis: Stable | 22 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Hemoptysis: Worsening | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Sore mouth: Stable | 21 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Sore mouth: Worsening | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Dysphagia: Improvement | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Dysphagia: Stable | 18 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Dysphagia: Worsening | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Peripheral neuropathy: Improvement | 4 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Peripheral neuropathy: Stable | 14 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Peripheral neuropathy: Worsening | 5 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Alopecia: Improvement | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Alopecia: Stable | 18 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Alopecia: Worsening | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Chest pain: Improvement | 7 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Chest pain: Stable | 13 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Chest pain: Worsening | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Arm/shoulder pain: Improvement | 9 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Arm/shoulder pain: Stable | 13 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Arm/shoulder pain: Worsening | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Pain elsewhere: Improvement | 7 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Pain elsewhere: Stable | 8 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 1, Pain elsewhere: Worsening | 6 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Dyspnoea: Improvement | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Dyspnoea: Stable | 6 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Dyspnoea: Worsening | 7 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Cough: Improvement | 7 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Cough: Stable | 6 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Cough: Worsening | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Hemoptysis: Improvement | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Hemoptysis: Worsening | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Sore mouth: Improvement | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Sore mouth: Stable | 14 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Dysphagia: Stable | 10 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Dysphagia: Worsening | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Peripheral neuropathy: Improvement | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Peripheral neuropathy: Stable | 8 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Peripheral neuropathy: Worsening | 6 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Alopecia: Improvement | 4 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Alopecia: Stable | 11 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Alopecia: Worsening | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Chest pain: Improvement | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Chest pain: Stable | 10 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Chest pain: Worsening | 4 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Arm/shoulder pain: Improvement | 5 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Arm/shoulder pain: Stable | 10 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Arm/shoulder pain: Worsening | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Pain elsewhere: Improvement | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Pain elsewhere: Stable | 8 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End cycle 3, Pain elsewhere: Worsening | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Dyspnoea: Improvement | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Dyspnoea: Stable | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Dyspnoea: Worsening | 4 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Cough: Improvement | 4 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Cough: Stable | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Hemoptysis: Improvement | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Hemoptysis: Worsening | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Sore mouth: Improvement | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Sore mouth: Worsening | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Dysphagia: Improvement | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Dysphagia: Stable | 4 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Dysphagia: Worsening | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Peripheral neuropathy: Improvement | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Peripheral neuropathy: Stable | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Peripheral neuropathy: Worsening | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Alopecia: Improvement | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Alopecia: Stable | 5 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Alopecia: Worsening | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Chest pain: Improvement | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Chest pain: Stable | 4 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Chest pain: Worsening | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Arm/shoulder pain: Improvement | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Arm/shoulder pain: Stable | 3 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Arm/shoulder pain: Worsening | 0 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Pain elsewhere: Improvement | 1 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Pain elsewhere: Stable | 2 Participants |
| ALK Treatment Sub-study | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | Baseline-End of treatment, Pain elsewhere: Worsening | 2 Participants |
Primary
Progression-Free Survival (PFS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study
Progression-free survival (PFS) was defined as the period between the first day of treatment and the first day that progressive disease (PD) (at least a 20% increase \[including an absolute increase of at least 5 mm\] in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions) was observed according to response evaluation criteria in solid tumors (RECIST) criteria, or death. Participants who have not had an event at the time of the analysis of the study data were censored at the date of the last available follow-up.
Time frame: From first day of treatment until date of progressive disease, death or censored, whichever was the earliest (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
Population: For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ALK Treatment Sub-study | Progression-Free Survival (PFS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study | 15.8 Months |
| ROS1 Treatment Sub-study | Progression-Free Survival (PFS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study | 7.5 Months |