Non-small Cell Lung Cancer
Conditions
Keywords
prevalence of ALK rearrangement, NSCLC, MENA
Brief summary
Thet study aims to estimate the prevalence of ALK rearrangement in the Middle East North Africa population by using the Ventana ALK-IHC method for ALK protein detection in retrospective NSCLC clinical samples, & to evaluate the association of ALK rearrangement with clinical and pathological parameters of NSCLC patients in MENA.
Detailed description
This is a retrospective, cross-sectional non-interventional epidemiology study to investigate the prevalence of ALK rearrangement in NSCLC patients in Middle East & North Africa. Approximately 700 retained tumor tissue specimens (tissue block) of patients previously diagnosed with NSCLC will be selected & subjected to ALK immune-staining using Ventana anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody combined with OptiView Benchmark System in 6-8 centers in 5-7 countries in the MENA region. The tissue samples of NSCLC cases will be retrieved from tissue banks of the molecular diagnostic units & pathology departments in these study centers. The histological diagnosis will be confirmed by the pathologists. The retained samples will then be tested by performing the Ventana ALK-IHC to assess the absence or presence of the ALK rearrangement by the detection of the ALK protein in formalin-fixed, paraffin-embedded NSCLC stored tissue samples using Ventana anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody (Roche Diagnostics GmbH) in the selected study centers. The results of ALK testing within this study population will then be used to establish the prevalence of ALK rearrangement in MENA NSCLC patients. The patients' characteristics, demographic, clinical and pathologic parameters will be obtained from their medical records & analyzed to determine any association with the presence of the EML4-ALK fusion gene in MENA NSCLC patients. The assessment of concordance of the results between FISH & IHC will be done in 2-3 centers. Results of FISH testing will be collected & recorded, if the retained tissue samples had been previously tested. If not, the Vysis FISH test will be performed, to assess the concordance between the results obtained using Vysis Break-apart FISH & Ventana IHC testing methods for ALK rearrangement detection.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- 1. Histological confirmation of nonsquamous NSCLC, with any TNM stage. 2. Available and sufficient tissue sample for ALK testing 3.Tissue samples are less than 5 years old 4.Routinely processed formalin-fixed, paraffin-embedded tissue samples only (see
Exclusion criteria
pertaining to tissue samples). 5.Histological sections mounted on glass slides must not be older than 3 months 6.Age \> 18 years 7.Any ECOG Performance status 8.Still alive, or death confirmed before inclusion, or is unknown 9.Disease diagnosis and/or treatment in one of the centers, in the last 5 years, assigned to participate in the study; 10.Written informed consent for general investigational testing was previously obtained, or specifically obtained for this retrospective epidemiology study, or having a documented waiver for the Informed consent document use, as required by local regulatory authorities, &/or Research Ethics committee/Institutional Review Board.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Rearrangement | 3 years | Participants with prevalence of ALK rearrangement were positive for ALK: defined as presence of strong granular cytoplasmic staining in tumor cells (any percentage of positive tumor cells). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender | 3 years | In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the gender of study participants. |
| Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race | 3 years | In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the race of study participants. |
| Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History | 3 years | In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the smoking history of study participants as participants who never smoked, current smoker and ex-smoker. |
| Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage | 3 years | In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the tumor stage of study participants. |
| Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type | 3 years | In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the treatment type of study participants. |
| Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Progression Free Survival (PFS) | 3 years | In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the PFS of study participants. |
| Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis | 3 years | In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the diagnosis of tumor histology of study participants. |
| Percentage Agreement Between Vysis Fluorescent In Situ Hybridization (FISH) and Ventana Immunohistochemistry (IHC) Methods for ALK Rearrangement Detection | 3 years | Percent overall agreement between Vysis ALK-FISH and Ventana ALK IHC tests and its 95% CI is reported in this outcome measure. |
| Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR) | 3 years | Percentage of participants with best overall response. Complete response (CR) is equal to (=) disappearance of all target lesions. Partial Response (PR) = greater than equal to (\>=) 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) \>= 20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of \>= 1 new lesion. Stable disease (SD) =neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start. |
| Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Participant's Status | 3 years | In this outcome measure participant's status at the time of sampling were evaluable for treatment-naive and treated. |
| Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status | 3 years | In this outcome measure EGFR status of participants were evaluable for not tested, wild type and mutant. |
| Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Knowledge Representation for Autonomous Systems (KRAS) Status | 3 years | In this outcome measure KRAS status of participants were evaluable for not tested, wild type, and mutant. |
| Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Line of Therapy | 3 years | In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the line of therapy of study participants. |
Countries
Egypt, Lebanon, Morocco, Saudi Arabia, United Arab Emirates
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-Small Cell Lung Cancer Tissue samples of participants of MENA previously diagnosed with NSCLC were tested retrospectively for the prevalence of ALK rearrangement. | 449 |
| Total | 449 |
Baseline characteristics
| Characteristic | Non-Small Cell Lung Cancer |
|---|---|
| Age, Customized 18 to 65 years | 272 Participants |
| Age, Customized Greater than equal to 65 years | 157 Participants |
| Age, Customized Missing | 20 Participants |
| Race/Ethnicity, Customized Arabic | 389 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants |
| Race/Ethnicity, Customized Other | 5 Participants |
| Race/Ethnicity, Customized White / Caucasian | 54 Participants |
| Sex: Female, Male Female | 141 Participants |
| Sex: Female, Male Male | 308 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Percentage of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Rearrangement
Participants with prevalence of ALK rearrangement were positive for ALK: defined as presence of strong granular cytoplasmic staining in tumor cells (any percentage of positive tumor cells).
Time frame: 3 years
Population: Full analysis set (FAS).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Small Cell Lung Cancer | Percentage of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Rearrangement | 8.69 percentage of participants |
Secondary
Percentage Agreement Between Vysis Fluorescent In Situ Hybridization (FISH) and Ventana Immunohistochemistry (IHC) Methods for ALK Rearrangement Detection
Percent overall agreement between Vysis ALK-FISH and Ventana ALK IHC tests and its 95% CI is reported in this outcome measure.
Time frame: 3 years
Population: FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Small Cell Lung Cancer | Percentage Agreement Between Vysis Fluorescent In Situ Hybridization (FISH) and Ventana Immunohistochemistry (IHC) Methods for ALK Rearrangement Detection | 98.45 percentage agreement |
Secondary
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status
In this outcome measure EGFR status of participants were evaluable for not tested, wild type and mutant.
Time frame: 3 years
Population: FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status | Not tested | 12.0 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status | Wild type | 6.8 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status | Mutant | 0 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status | Unknown | 0 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status | Other | 14.3 percentage of participants |
p-value: 0.0294Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender
In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the gender of study participants.
Time frame: 3 years
Population: FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender | Male | 10.1 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender | Female | 5.7 percentage of participants |
p-value: 0.130495% CI: [0.8, 4.77]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Knowledge Representation for Autonomous Systems (KRAS) Status
In this outcome measure KRAS status of participants were evaluable for not tested, wild type, and mutant.
Time frame: 3 years
Population: FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Knowledge Representation for Autonomous Systems (KRAS) Status | Not tested | 9.0 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Knowledge Representation for Autonomous Systems (KRAS) Status | Wild type | 0 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Knowledge Representation for Autonomous Systems (KRAS) Status | Mutant | 0 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Knowledge Representation for Autonomous Systems (KRAS) Status | Unknown | 0 percentage of participants |
p-value: 0.6877Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Line of Therapy
In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the line of therapy of study participants.
Time frame: 3 years
Population: FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Line of Therapy | First-line | 9.1 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Line of Therapy | Second-line | 8.5 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Line of Therapy | Unknown | 9.4 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Line of Therapy | Missing | 3.1 percentage of participants |
p-value: 0.978Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR)
Percentage of participants with best overall response. Complete response (CR) is equal to (=) disappearance of all target lesions. Partial Response (PR) = greater than equal to (\>=) 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) \>= 20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of \>= 1 new lesion. Stable disease (SD) =neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.
Time frame: 3 years
Population: FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR) | CR | 14.3 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR) | PR | 20.0 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR) | PD | 7.6 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR) | SD | 1.8 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR) | Unknown | 9.9 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR) | Missing | 0 percentage of participants |
p-value: 0.1144Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Participant's Status
In this outcome measure participant's status at the time of sampling were evaluable for treatment-naive and treated.
Time frame: 3 years
Population: FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Participant's Status | Treatment-naive | 8.2 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Participant's Status | Treated | 11.1 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Participant's Status | Unknown | 33.3 percentage of participants |
p-value: 0.0862Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Progression Free Survival (PFS)
In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the PFS of study participants.
Time frame: 3 years
Population: FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Progression Free Survival (PFS) | 8.0 percentage of participants |
p-value: 0.9231Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race
In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the race of study participants.
Time frame: 3 years
Population: FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race | White /Caucasian | 11.1 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race | Arabic | 8.5 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race | Others | 0 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race | Missing | 0 percentage of participants |
p-value: 0.6422Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History
In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the smoking history of study participants as participants who never smoked, current smoker and ex-smoker.
Time frame: 3 years
Population: FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History | Never | 9.0 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History | Current | 7.5 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History | Ex-smoker | 5.8 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History | Unknown | 11.9 percentage of participants |
p-value: 0.4524Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type
In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the treatment type of study participants.
Time frame: 3 years
Population: FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type | Surgery with chemotherapy | 7.5 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type | Surgery without chemotherapy | 5.2 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type | Targeted therapy | 10.0 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type | Chemotherapy only | 10.4 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type | Other | 7.8 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type | Unknown | 9.9 percentage of participants |
p-value: 0.8785Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis
In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the diagnosis of tumor histology of study participants.
Time frame: 3 years
Population: FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis | Adenocarcinoma: Positive | 8.6 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis | Large cell carcinoma: Positive | 16.7 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis | Not specified | 0 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis | Others | 9.1 percentage of participants |
p-value: 0.901Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage
In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the tumor stage of study participants.
Time frame: 3 years
Population: FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage | Stage 1 | 6.3 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage | Stage 2 | 7.8 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage | Stage 3 | 6.3 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage | Stage 3 A | 0 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage | Stage 3 B | 10.0 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage | Stage 4 | 10.0 percentage of participants |
| Non-Small Cell Lung Cancer | Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage | Missing | 7.0 percentage of participants |
p-value: 0.9067Cochran-Mantel-Haenszel