Non-Squamous Non-Small Cell Lung Cancer
Conditions
Brief summary
This study will assess the prevalence of epidermal growth factor receptor (EGFR) mutations in newly diagnosed patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients with positive EGFR mutation results will enter an open-label, single arm study to evaluate progression-free survival and quality of life with first-line Tarceva (erlotinib) therapy. Patients will receive Tarceva at a dose of 150 mg orally daily. Anticipated time on study treatment is until progressive disease or unacceptable toxicity occurs. Patients with negative EGFR mutation results will be offered treatment as per the centre's standard of care.
Interventions
DRUGerlotinib [Tarceva]
150 mg daily, orally
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/= 18 years of age * Locally advanced or metastatic (stage IIIB/IV) non-small cell lung cancer (NSCLC) * ECOG performance status 0-3 * Treatment phase: histologically confirmed EGFR exon 19 deletion or exon 21 mutation in the diagnostic phase of the study * Adequate haematological, liver and renal function * Female patients must be postmenopausal, surgically sterile, or agree to use a barrier method of contraception * Male patients must be surgically sterile or agree to use a barrier method of contraception
Exclusion criteria
* Previous treatment for NSCLC with chemotherapy or therapy against EGFR, either with antibody or small molecule (tyrosine kinase inhibitor) * Symptomatic cerebral metastases * Pregnant or lactating women * Any other concomitant anti-cancer therapy (until disease progression and discontinuation of Tarceva therapy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With EGFR Mutations by Subgroup | 14 Days | Incidence of EGFR mutations were summarized with respect to different subgroups as follows: (1) equals (=) Histopathology, (2) = Stage of disease, (3) = Age at consent, (4) = Gender, (5) = Race, (6) = Smoking history. |
| Percentage of Participants Who Tested Positive for EGFR Mutations | 14 days | All participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletion or exon 21 mutations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival Time in Months | Baseline, Day 1 of each 6-week visit starting from Visit 3 until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months | Duration of time in months from Screening until Death due to any cause. |
| Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument | Screening, Baseline and Final or Withdrawal Visit up to 34 months | The EQ-5D contains a descriptive system that measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). A negative change indicates improvement. |
| Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their mobility as the following categories: Category 1. I have no problems in walking about; Category 2. I have some problems in walking about; Category 3. I am confined to bed. |
| Percentage of Participants With a Response by Best Objective Tumor Response | Screening, Day 1 of each 6 week visit starting from Visit 3 until PD, Death, Unacceptable Toxicity or Withdrawal of Consent up to 34 months | Best objective response was defined as the best response recorded from the start of treatment until disease progression/recurrence. Tumor response was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). Partial Response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their ability to perform usual activities as the following categories: Category 1. I have no problems with performing my usual activities; Category 2. I have some problems with performing my usual activities; Category 3. I am unable to perform my usual activities. |
| Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I have no pain or discomfort; Category 2. I have moderate pain or discomfort; Category 3. I have extreme pain or discomfort. |
| Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I am not anxious or depressed; Category 2. I am moderately anxious or depressed; Category 3.I am extremely anxious or depressed. |
| Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months | The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their self-care as the following categories: Category 1. I have no problems with self-care; Category 2. I have some problems washing or dressing myself; Category 3. I am unable to wash or dress myself. |
| Probability of Being Alive and Free of Progression by Timepoint | Months 0, 3, 6, 9, 12, 15, and 18 | Progression Free Survival (PFS) was defined as the interval (number of days) from the trial treatment start date to the earlier of the date of the first tumor response assessment of PD or the date of death by any cause. Participants who experienced neither of these events or who were lost to followup at the time of the analysis were censored at date of last contact. PFS was summarized according to the Kaplan-Meier method. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NSCLC Group During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations. | 688 |
| Total | 688 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Diagnostic Phase | Failed to Produce a Test Results | 69 | 0 |
| Diagnostic Phase | Participants Not Tested | 44 | 0 |
| Treatment Phase | Adverse Event | 0 | 2 |
| Treatment Phase | Death | 0 | 2 |
| Treatment Phase | Progressive Disease | 0 | 32 |
| Treatment Phase | Unknown reason | 0 | 4 |
| Treatment Phase | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | NSCLC Group |
|---|---|
| Age, Continuous | 68.0 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 299 Participants |
| Sex: Female, Male Male | 389 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 40 / 41 |
| serious Total, serious adverse events | 16 / 41 |
Outcome results
Primary
Percentage of Participants Who Tested Positive for EGFR Mutations
All participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletion or exon 21 mutations.
Time frame: 14 days
Population: Diagnostic population; Only participants who were tested for EGFR mutations were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NSCLC Group | Percentage of Participants Who Tested Positive for EGFR Mutations | 8.1 percentage of participants |
Primary
Percentage of Participants With EGFR Mutations by Subgroup
Incidence of EGFR mutations were summarized with respect to different subgroups as follows: (1) equals (=) Histopathology, (2) = Stage of disease, (3) = Age at consent, (4) = Gender, (5) = Race, (6) = Smoking history.
Time frame: 14 Days
Population: Only participants with a valid EGFR mutations test result were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (1) Squamous cell carcinoma | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (1) Adenocarcinoma | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (1) Bronchoalveolar carcinoma | 0 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (1) Large cell carcinoma | 0 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (1) Other | 0 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (2) Unresectable Stage IIIB | 1.9 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (2) Stage IIIB with malignant effusions | 1.9 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (2) Stage IV | 96.2 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (3) Less than 70 years | 73.1 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (3) Greater than 70 years | 26.9 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (4) Male | 23.1 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (4) Female | 76.9 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (5) Asian | 13.5 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (5) Black | 9.6 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (5) Caucasian | 75.0 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (5) Other | 1.9 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (6) Never smoked | 44.2 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (6) Previous smoker | 44.2 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (6) Current smoker | 7.7 percentage of participants |
| NSCLC Group | Percentage of Participants With EGFR Mutations by Subgroup | (6) Missing | 3.8 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (6) Previous smoker | 60.6 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (1) Squamous cell carcinoma | 22.6 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (4) Male | 60.8 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (1) Adenocarcinoma | 67.3 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (5) Other | 0.4 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (1) Bronchoalveolar carcinoma | 1.7 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (4) Female | 39.2 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (1) Large cell carcinoma | 0.6 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (6) Missing | 0.6 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (1) Other | 7.8 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (5) Asian | 2.9 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (2) Unresectable Stage IIIB | 11.9 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (6) Never smoked | 7.8 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (2) Stage IIIB with malignant effusions | 3.4 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (5) Black | 3.3 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (2) Stage IV | 84.7 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (6) Current smoker | 31.0 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (3) Less than 70 years | 55.6 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (5) Caucasian | 93.5 percentage of participants |
| EGFR Negative | Percentage of Participants With EGFR Mutations by Subgroup | (3) Greater than 70 years | 44.4 percentage of participants |
p-value: 0Wald Test
p-value: 0.1038Wald Test
p-value: 0.0588Wald Test
p-value: 0.4802Wald Test
p-value: 0.0147Wald Test
p-value: 0.1181Wald Test
p-value: 0Wald Test
p-value: 0.0006Wald Test
p-value: 0.0004Wald Test
p-value: 0.3371Wald Test
p-value: 0Wald Test
p-value: 0.0001Wald Test
Secondary
Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I am not anxious or depressed; Category 2. I am moderately anxious or depressed; Category 3.I am extremely anxious or depressed.
Time frame: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months
Population: ITT population; n = number of participants analyzed for the given parameter at the specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Screening Category 1 (n=40) | 52.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Screening Category 2 (n=40) | 37.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Screening Category 3 (n=40) | 10.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 01 Category 1 (n=19) | 57.9 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 01 Category 2 (n=19) | 42.1 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 01 Category 3 (n=19) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 02 Category 1 (n=33) | 57.6 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 02 Category 2 (n=33) | 42.4 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 02 Category 3 (n=33) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 03 Category 1 (n=30) | 43.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 03 Category 2 (n=30) | 56.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 03 Category 3 (n=30) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 04 Category 1 (n=29) | 58.6 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 04 Category 2 (n=29) | 41.4 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 04 Category 3 (n=29) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 05 Category 1 (n=33) | 60.6 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 05 Category 2 (n=33) | 36.4 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 05 Category 3 (n=33) | 3.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 06 Category 1 (n=31) | 48.4 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 06 Category 2 (n=31) | 51.6 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 06 Category 3 (n=31) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 07 Category 1 (n=29) | 62.1 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 07 Category 2 (n=29) | 37.9 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 07 Category 3 (n=29) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 08 Category 1 (n=27) | 55.6 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 08 Category 2 (n=27) | 44.4 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 08 Category 3 (n=27) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 09 Category 1 (n=24) | 62.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 09 Category 2 (n=24) | 25.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 09 Category 3 (n=24) | 12.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 10 Category 1 (n=21) | 61.9 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 10 Category 2 (n=21) | 28.6 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 10 Category 3 (n=21) | 9.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 11 Category 1 (n=13) | 61.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 11 Category 2 (n=13) | 30.8 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 11 Category 3 (n=13) | 7.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 12 Category 1 (n=11) | 45.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 12 Category 2 (n=11) | 45.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 12 Category 3 (n=11) | 9.1 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 13 Category 1 (n=9) | 77.8 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 13 Category 2 (n=9) | 22.2 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 13 Category 3 (n=9) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 14 Category 1 (n=8) | 75.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 14 Category 2 (n=8) | 25.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 14 Category 3 (n=8) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 15 Category 1 (n=5) | 60.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 15 Category 2 (n=5) | 40.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 15 Category 3 (n=5) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 16 Category 1 (n=4) | 75.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 16 Category 2 (n=4) | 25.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 16 Category 3 (n=4) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 17 Category 1 (n=4) | 75.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 17 Category 2 (n=4) | 25.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 17 Category 3 (n=4) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 18 Category 1 (n=3) | 66.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 18 Category 2 (n=3) | 33.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 18 Category 3 (n=3) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 19 Category 1 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 19 Category 2 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 19 Category 3 (n=2) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 20 Category 1 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 20 Category 2 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 20 Category 3 (n=2) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 21 Category 1 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 21 Category 2 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 21 Category 3 (n=2) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 22 Category 1 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 22 Category 2 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 22 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 23 Category 1 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 23 Category 2 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 23 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 24 Category 1 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 24 Category 2 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 24 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 25 Category 1 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 25 Category 2 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Visit 25 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Final visit/Withdrawal Category 1 (n=21) | 57.1 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Final visit/Withdrawal Category 2 (n=21) | 38.1 percentage of participants |
| NSCLC Group | Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D | Final visit/Withdrawal Category 3 (n=21) | 4.8 percentage of participants |
Secondary
Percentage of Participants With a Response by Best Objective Tumor Response
Best objective response was defined as the best response recorded from the start of treatment until disease progression/recurrence. Tumor response was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). Partial Response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time frame: Screening, Day 1 of each 6 week visit starting from Visit 3 until PD, Death, Unacceptable Toxicity or Withdrawal of Consent up to 34 months
Population: Intention-to-treat (ITT) population: All participants in the target population who were eligible for treatment and who actually received one dose of treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NSCLC Group | Percentage of Participants With a Response by Best Objective Tumor Response | CR | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With a Response by Best Objective Tumor Response | PR | 84.8 percentage of participants |
| NSCLC Group | Percentage of Participants With a Response by Best Objective Tumor Response | SD | 9.1 percentage of participants |
| NSCLC Group | Percentage of Participants With a Response by Best Objective Tumor Response | PD | 6.1 percentage of participants |
Secondary
Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their pain as the following categories: Category 1. I have no pain or discomfort; Category 2. I have moderate pain or discomfort; Category 3. I have extreme pain or discomfort.
Time frame: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months
Population: ITT population; n = number of participants analyzed for the given parameter at the specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Screening Category 1 (n=41) | 29.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Screening Category 2 (n=41) | 63.4 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Screening Category 3 (n=41) | 7.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 01 Category 1 (n=20) | 10.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 01 Category 2 (n=20) | 85.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 01 Category 3 (n=20) | 5.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 02 Category 1 (n=32) | 43.8 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 02 Category 2 (n=32) | 56.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 02 Category 3 (n=32) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 03 Category 1 (n=30) | 40.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 03 Category 2 (n=30) | 60.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 03 Category 3 (n=30) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 04 Category 1 (n=29) | 55.2 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 04 Category 2 (n=29) | 37.9 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 04 Category 3 (n=29) | 6.9 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 05 Category 1 (n=33) | 45.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 05 Category 2 (n=33) | 51.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 05 Category 3 (n=33) | 3.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 06 Category 1 (n=31) | 48.4 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 06 Category 2 (n=31) | 51.6 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 06 Category 3 (n=31) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 07 Category 1 (n=29) | 48.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 07 Category 2 (n=29) | 51.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 07 Category 3 (n=29) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 08 Category 1 (n=27) | 37.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 08 Category 2 (n=27) | 59.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 08 Category 3 (n=27) | 3.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 09 Category 1 (n=24) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 09 Category 2 (n=24) | 37.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 09 Category 3 (n=24) | 12.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 10 Category 1 (n=21) | 42.9 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 10 Category 2 (n=21) | 47.6 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 10 Category 3 (n=21) | 9.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 11 Category 1 (n=13) | 46.2 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 11 Category 2 (n=13) | 53.8 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 11 Category 3 (n=13) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 12 Category 1 (n=11) | 45.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 12 Category 2 (n=11) | 36.4 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 12 Category 3 (n=11) | 18.2 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 13 Category 1 (n=9) | 44.4 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 13 Category 2 (n=9) | 55.6 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 13 Category 3 (n=9) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 14 Category 1 (n=8) | 62.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 14 Category 2 (n=8) | 37.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 14 Category 3 (n=8) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 15 Category 1 (n=5) | 60.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 15 Category 2 (n=5) | 40.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 15 Category 3 (n=5) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 16 Category 1 (n=4) | 25.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 16 Category 2 (n=4) | 75.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 16 Category 3 (n=4) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 17 Category 1 (n=4) | 25.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 17 Category 2 (n=4) | 75.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 17 Category 3 (n=4) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 18 Category 1 (n=3) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 18 Category 2 (n=3) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 18 Category 3 (n=3) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 19 Category 1 (n=2) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 19 Category 2 (n=2) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 19 Category 3 (n=2) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 20 Category 1 (n=2) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 20 Category 2 (n=2) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 20 Category 3 (n=2) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 21 Category 1 (n=2) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 21 Category 2 (n=2) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 21 Category 3 (n=2) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 22 Category 1 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 22 Category 2 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 22 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 23 Category 1 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 23 Category 2 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 23 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 24 Category 1 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 24 Category 2 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 24 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 25 Category 1 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 25 Category 2 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Visit 25 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Final visit/Withdrawal Category 1 (n=21) | 38.1 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Final visit/Withdrawal Category 2 (n=21) | 57.1 percentage of participants |
| NSCLC Group | Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D | Final visit/Withdrawal Category 3 (n=21) | 4.8 percentage of participants |
Secondary
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their mobility as the following categories: Category 1. I have no problems in walking about; Category 2. I have some problems in walking about; Category 3. I am confined to bed.
Time frame: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months
Population: ITT population; n = number of participants analyzed at for the given parameter at the specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Screening Category 1 (n=41) | 43.9 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Screening Category 2 (n=41) | 56.1 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Screening Category 3 (n=41) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 01 Category 1 (n=20) | 45.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 01 Category 2 (n=20) | 55.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 01 Category 3 (n=20) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 02 Category 1 (n=33) | 45.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 02 Category 2 (n=33) | 54.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 02 Category 3 (n=33) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 03 Category 1 (n=30) | 56.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 03 Category 2 (n=30) | 43.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 03 Category 3 (n=30) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 04 Category 1 (n=29) | 51.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 04 Category 2 (n=29) | 48.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 04 Category 3 (n=29) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 05 Category 1 (n=33) | 54.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 05 Category 2 (n=33) | 45.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 05 Category 3 (n=33) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 06 Category 1 (n=31) | 54.8 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 06 Category 2 (n=31) | 45.2 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 06 Category 3 (n=31) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 07 Category 1 (n=29) | 58.6 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 07 Category 2 (n=29) | 41.4 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 07 Category 3 (n=29) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 08 Category 1 (n=27) | 55.6 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 08 Category 2 (n=27) | 44.4 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 08 Category 3 (n=27) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 09 Category 1 (n=24) | 62.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 09 Category 2 (n=24) | 37.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 09 Category 3 (n=24) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 10 Category 1 (n=21) | 42.9 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 10 Category 2 (n=21) | 57.1 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 10 Category 3 (n=21) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 11 Category 1 (n=13) | 46.2 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 11 Category 2 (n=13) | 53.8 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 11 Category 3 (n=13) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 12 Category 1 (n=11) | 45.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 12 Category 2 (n=11) | 54.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 12 Category 3 (n=11) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 13 Category 1 (n=9) | 55.6 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 13 Category 2 (n=9) | 44.4 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 13 Category 3 (n=9) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 14 Category 1 (n=8) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 14 Category 2 (n=8) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 14 Category 3 (n=8) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 15 Category 1 (n=5) | 40.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 15 Category 2 (n=5) | 60.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 15 Category 3 (n=5) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 16 Category 1 (n=4) | 25.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 16 Category 2 (n=4) | 75.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 16 Category 3 (n=4) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 17 Category 1 (n=4) | 25.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 17 Category 2 (n=4) | 75.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 17 Category 3 (n=4) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 18 Category 1 (n=3) | 33.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 18 Category 2 (n=3) | 66.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 18 Category 3 (n=3) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 19 Category 1 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 19 Category 2 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 19 Category 3 (n=2) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 20 Category 1 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 20 Category 2 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 20 Category 3 (n=2) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 21 Category 1 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 21 Category 2 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 21 Category 3 (n=2) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 22 Category 1 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 22 Category 2 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 22 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 23 Category 1 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 23 Category 2 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 23 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 24 Category 1 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 24 Category 2 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 24 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 25 Category 1 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 25 Category 2 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Visit 25 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Final visit/Withdraw Category 1 (n=21) | 33.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Final visit/Withdraw Category 2 (n=21) | 66.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D | Final visit/Withdraw Category 3 (n=21) | 0.0 percentage of participants |
Secondary
Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their self-care as the following categories: Category 1. I have no problems with self-care; Category 2. I have some problems washing or dressing myself; Category 3. I am unable to wash or dress myself.
Time frame: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months
Population: ITT population; n = number of participants analyzed for the given parameter at the specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Screening Category 1 (n=41) | 78.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Screening Category 2 (n=41) | 17.1 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Screening Category 3 (n=41) | 4.9 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 01 Category 1 (n=20) | 80.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 01 Category 2 (n=20) | 20.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 01 Category 3 (n=20) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 02 Category 1 (n=33) | 81.8 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 02 Category 2 (n=33) | 18.2 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 02 Category 3 (n=33) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 03 Category 1 (n=29) | 86.2 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 03 Category 2 (n=29) | 13.8 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 03 Category 3 (n=29) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 04 Category 1 (n=28) | 82.1 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 04 Category 2 (n=28) | 17.9 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 04 Category 3 (n=28) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 05 Category 1 (n=33) | 78.8 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 05 Category 2 (n=33) | 21.2 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 05 Category 3 (n=33) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 06 Category 1 (n=31) | 83.9 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 06 Category 2 (n=31) | 16.1 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 06 Category 3 (n=31) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 07 Category 1 (n=29) | 79.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 07 Category 2 (n=29) | 20.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 07 Category 3 (n=29) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 08 Category 1 Visit 08 Category 1 (n=27) | 85.2 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 08 Category 2 (n=27) | 14.8 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 08 - Category 3 (n=27) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 09 Category 1 (n=24) | 75.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 09 Category 2 (n=24) | 25.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 09 Category 3 (n=24) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 10 Category 1 (n=21) | 71.4 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 10 Category 2 (n=21) | 28.6 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 10 Category 3 (n=21) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 11 Category 1 (n=13) | 61.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 11 Category 2 (n=13) | 38.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 11 Category 3 (n=13) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 12 Category 1 (n=11) | 54.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 12 Category 2 (n=11) | 45.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 12 Category 3 (n=11) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 13 Category 1 (n=9) | 55.6 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 13 Category 2 (n=9) | 44.4 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 13 Category 3 (n=9) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 14 Category 1 (n=8) | 62.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 14 Category 2 (n=8) | 37.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 14 Category 3 (n=8) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 15 Category 1 (n=5) | 40.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 15 Category 2 (n=5) | 60.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 15 Category 3 (n=5) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 16 Category 1 (n=4) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 16 Category 2 ((n=4)) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 16 Category 3 (n=4) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 17 Category 1 (n=4) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 17 Category 2 (n=4) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 17 Category 3 (n=4) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 18 Category 1 (n=3) | 33.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 18 Category 2 (n=3) | 66.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 18 Category 3 (n=3) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 19 Category 1 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 19 Category 2 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 19 Category 3 (n=2) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 20 Category 1 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 20 Category 2 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 20 Category 3 (n=2) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 21 Category 1 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 21 Category 2 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 21 Category 3 (n=2) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 22 Category 1 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 22 Category 2 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 22 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 23 Category 1 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 23 Category 2 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 23 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 24 Category 1 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 24 Category 2 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 24 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 25 Category 1 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 25 Category 2 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Visit 25 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Final visit/Withdraw Category 1 (n=21) | 66.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Final visit/Withdraw Category 2 (n=21) | 33.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D | Final visit/Withdraw Category 3 (n=21) | 0.0 percentage of participants |
Secondary
Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D
The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their ability to perform usual activities as the following categories: Category 1. I have no problems with performing my usual activities; Category 2. I have some problems with performing my usual activities; Category 3. I am unable to perform my usual activities.
Time frame: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months
Population: ITT population; n = number of participants analyzed for the given parameter at the specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 05 Category 2 (n=33) | 48.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 05 Category 3 (n=33) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 06 Category 1 (n=31) | 45.2 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 06 Category 2 (n=31) | 54.8 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 06 Category 3 (n=31) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 07 Category 1 (n=29) | 48.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 07 Category 2 (n=29) | 51.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 07 Category 3 (n=29) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 08 Category 1 (n=27) | 40.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 08 Category 2 (n=27) | 59.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 08 Category 3 (n=27) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 09 Category 1 (n=24) | 33.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 09 Category 2 (n=24) | 66.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 09 Category 3 (n=24) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 10 Category 1 (n=21) | 38.1 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 10 Category 2 (n=21) | 61.9 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 10 Category 3 (n=21) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 11 Category 1 (n=13) | 30.8 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 11 Category 2 (n=13) | 69.2 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 11 Category 3 (n=13) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 12 Category 1 (n=11) | 27.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 12 Category 2 (n=11) | 72.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 12 Category 3 (n=11) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 13 Category 1 (n=9) | 22.2 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 13 Category 2 (n=9) | 77.8 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 13 Category 3 (n=9) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 14 Category 1 (n=8) | 37.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 14 Category 2 (n=8) | 62.5 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 14 Category 3 (n=8) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 15 Category 1 (n=5) | 20.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 15 Category 2 (n=5) | 80.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 15 Category 3 (n=5) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 16 Category 1 (n=4) | 25.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 16 Category 2 (n=4) | 75.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 16 Category 3 (n=4) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 17 Category 1 (n=4) | 25.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 17 Category 2 (n=4) | 75.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 17 Category 3 (n=4) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 18 Category 1 (n=3) | 33.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 18 Category 2 (n=3) | 66.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 18 Category 3 (n=3) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 19 Category 1 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 19 Category 2 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 19 Category 3 (n=2) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 20 Category 1 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 20 Category 2 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 20 Category 3 (n=2) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 21 Category 1 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 21 Category 2 (n=2) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 21 Category 3 (n=2) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 22 Category 1 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 22 Category 2 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 22 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 23 Category 1 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 23 Category 2 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 23 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 24 Category 1 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 24 Category 2 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 24 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 25 Category 1 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 25 Category 2 (n=1) | 100.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 25 Category 3 (n=1) | 0.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Final visit/Withdrawal Category 1 (n=21) | 33.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Final visit/Withdrawal Category 2 (n=21) | 61.9 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Final visit/Withdrawal Category 3 (n=21) | 4.8 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Screening Category 1 (n=41) | 39.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Screening Category 2 (n=41) | 46.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Screening Category 3 (n=41) | 14.6 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 01 Category 1 (n=20) | 40.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 01 Category 2 (n=20) | 50.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 01 Category 3 (n=20) | 10.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 02 Category 1 (n=33) | 36.4 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 02 Category 2 (n=33) | 60.6 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 02 Category 3 (n=33) | 3.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 03 Category 1 (n=30) | 40.0 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 03 Category 2 (n=30) | 53.3 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 03 Category 3 (n=30) | 6.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 04 Category 1 (n=29) | 51.7 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 04 Category 2 (n=29) | 44.8 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 04 Category 3 (n=29) | 3.4 percentage of participants |
| NSCLC Group | Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D | Visit 05 Category 1 (n=33) | 51.5 percentage of participants |
Secondary
Probability of Being Alive and Free of Progression by Timepoint
Progression Free Survival (PFS) was defined as the interval (number of days) from the trial treatment start date to the earlier of the date of the first tumor response assessment of PD or the date of death by any cause. Participants who experienced neither of these events or who were lost to followup at the time of the analysis were censored at date of last contact. PFS was summarized according to the Kaplan-Meier method.
Time frame: Months 0, 3, 6, 9, 12, 15, and 18
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NSCLC Group | Probability of Being Alive and Free of Progression by Timepoint | 0 Months | 1.00 probability of being alive |
| NSCLC Group | Probability of Being Alive and Free of Progression by Timepoint | 3 Months | 0.97 probability of being alive |
| NSCLC Group | Probability of Being Alive and Free of Progression by Timepoint | 6 Months | 0.94 probability of being alive |
| NSCLC Group | Probability of Being Alive and Free of Progression by Timepoint | 9 Months | 0.73 probability of being alive |
| NSCLC Group | Probability of Being Alive and Free of Progression by Timepoint | 12 Months | 0.54 probability of being alive |
| NSCLC Group | Probability of Being Alive and Free of Progression by Timepoint | 15 Months | 0.37 probability of being alive |
| NSCLC Group | Probability of Being Alive and Free of Progression by Timepoint | 18 Months | 0.22 probability of being alive |
Secondary
Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument
The EQ-5D contains a descriptive system that measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). A negative change indicates improvement.
Time frame: Screening, Baseline and Final or Withdrawal Visit up to 34 months
Population: ITT population; number (n) = number of participants analyzed for the given parameter at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NSCLC Group | Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument | Screening (n=40) | 62.6 mm | Standard Deviation 23.5 |
| NSCLC Group | Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument | Baseline (n=20) | 65.4 mm | Standard Deviation 19.9 |
| NSCLC Group | Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument | Final visit/Withdrawal (n=20) | 63.0 mm | Standard Deviation 22.4 |
| NSCLC Group | Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument | Change from Baseline Final visit(n=20) | -0.4 mm | Standard Deviation 22 |
Secondary
Survival Time in Months
Duration of time in months from Screening until Death due to any cause.
Time frame: Baseline, Day 1 of each 6-week visit starting from Visit 3 until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NSCLC Group | Survival Time in Months | 12.57 months |