Small Cell Lung Carcinoma
Conditions
Brief summary
This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.
Detailed description
With Amendment 4, the experimental Pembrolizumab/Vibostolimab arm (MK-7684A) was discontinued and all ongoing participants were offered an option to move to the comparator Atezolizumab monotherapy arm for the remainder of the study. There will be no further analyses of efficacy, and no European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) and Lung Cancer 13 module (EORTC QLQ-LC13) outcome measures will be reported. Effective as of Amendment 5, participants with access to approved standard of care (SOC) should be considered for discontinuation from the study. Those benefiting from atezolizumab, but unable to access it as SOC outside the study, may continue on study and receive treatment with atezolizumab until discontinuation criteria are met.
Interventions
Pembrolizumab 200 mg plus vibostolimab 200 mg fixed dose coformulation administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.
DRUGSaline placebo
Saline solution administered via IV infusion on Cycle 1 (and Q3W as needed beyond Cycle 1)
DRUGEtoposide
Etoposide 100 mg/m\^2 administered via IV infusion Q3W on Days 1 2, 3 of each cycle for up to 4 cycles
DRUGCisplatin
Cisplatin 75 mg/m\^2 administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.
BIOLOGICALAtezolizumab
Atezolizumab 1200 mg administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.
DRUGCarboplatin
Carboplatin AUC 5 mg/mL/min administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) in need of first-line therapy * Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan * Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse * Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse * Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 * Has a predicted life expectancy of \>3 months
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 25 months | Overall Survival (OS) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was calculated using the nonparametric Kaplan-Meier method for censored data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to approximately 25 months | ORR was defined as the percentage of participants in the analysis population who have a confirmed Complete Response (CR: disappearance of all lesions) or a Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR). Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The ORR was calculated using the Miettinen & Nurminen method stratified by baseline ECOG performance status (0 or 1), baseline LDH (≤ or \> upper limit of normal \[ULN\]), and baseline presence of liver metastasis (Yes or No), or brain metastasis (Yes or No). |
| Duration of Response (DOR) | Up to approximately 25 months | For participants who demonstrated a confirmed Complete Response (CR: disappearance of all lesions) or Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per RECIST 1.1, DOR was defined as the time from first documented CR or PR until progressive disease (PD) or death from any cause, whichever occurs first. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). DOR was calculated using the nonparametric Kaplan-Meier method for censored data. |
| Percentage of Participants Who Experienced an Adverse Event (AE) | Up to approximately 60 months | An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Percentage of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 60 months | An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. |
| Change From Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Baseline and up to approximately 60 months | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 (How would you rate your overall health during the past week? and How would you rate your overall QoL during the past week?) are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. |
| Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 | Baseline and up to approximately 60 months | The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. |
| Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 | Baseline and up to approximately 60 months | The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant response to the question Were you short of breath? is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. |
| Progression-Free Survival (PFS) | Up to approximately 25 months | PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). PFS was calculated using the nonparametric Kaplan-Meier method; participants who did not experience a PFS event were censored at the last disease assessment, or the last assessment before new anticancer treatment if new treatment was initiated. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented. |
| Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 | Baseline and up to approximately 60 months | EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question Have you had pain in your chest? is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. |
| Time to True Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30 | Baseline and up to approximately 60 months | The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of individuals with cancer. Participant responses to Items 29 and 30 (How would you rate your overall health during the past week? and How would you rate your overall QoL during the past week?) are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. |
| TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 | Baseline and up to approximately 60 months | The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. |
| TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 | Baseline and up to approximately 60 months | The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant response to the question Were you short of breath? is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. |
| TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 | Baseline and up to approximately 60 months | The EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question Have you coughed? is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. |
| TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 | Baseline and up to approximately 60 months | The EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question Have you had pain in your chest? is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. |
| Change From Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) | Baseline and up to approximately 60 months | The EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question Have you coughed? is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. |
Countries
Argentina, Australia, Austria, Canada, China, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Portugal, Romania, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pembrolizumab/Vibostolimab Participants received 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve \[AUC\] 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1. | 230 |
| Atezolizumab Participants received 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This was followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo was administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1. | 230 |
| Total | 460 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 153 | 138 |
| Overall Study | Ongoing | 75 | 88 |
| Overall Study | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | Pembrolizumab/Vibostolimab | Atezolizumab | Total |
|---|---|---|---|
| Age, Continuous | 63.6 Years STANDARD_DEVIATION 8.8 | 63.9 Years STANDARD_DEVIATION 8.5 | 63.7 Years STANDARD_DEVIATION 8.7 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline ECOG= 0 | 77 Participants | 81 Participants | 158 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline ECOG= 1 | 153 Participants | 149 Participants | 302 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 18 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 213 Participants | 209 Participants | 422 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 3 Participants | 8 Participants |
| Lactate Dehydrogenase (LDH) Status at Baseline ≤Upper Limit of Normal (ULN) | 92 Participants | 94 Participants | 186 Participants |
| Lactate Dehydrogenase (LDH) Status at Baseline >Upper Limit of Normal (ULN) | 138 Participants | 136 Participants | 274 Participants |
| Presence of Brain Metastases at Baseline No | 215 Participants | 215 Participants | 430 Participants |
| Presence of Brain Metastases at Baseline Yes | 15 Participants | 15 Participants | 30 Participants |
| Presence of Liver Metastases at Baseline No | 137 Participants | 132 Participants | 269 Participants |
| Presence of Liver Metastases at Baseline Yes | 93 Participants | 98 Participants | 191 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 78 Participants | 64 Participants | 142 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 4 Participants | 14 Participants |
| Race (NIH/OMB) White | 135 Participants | 158 Participants | 293 Participants |
| Sex: Female, Male Female | 76 Participants | 64 Participants | 140 Participants |
| Sex: Female, Male Male | 154 Participants | 166 Participants | 320 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 155 / 230 | 141 / 230 |
| other Total, other adverse events | 228 / 229 | 222 / 229 |
| serious Total, serious adverse events | 120 / 229 | 96 / 229 |
Outcome results
Primary
Overall Survival (OS)
Overall Survival (OS) was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was calculated using the nonparametric Kaplan-Meier method for censored data.
Time frame: Up to approximately 25 months
Population: Per protocol, the analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab/Vibostolimab | Overall Survival (OS) | 11.5 Months |
| Atezolizumab | Overall Survival (OS) | 12.9 Months |
Comparison: Statistical analyses stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).p-value: 0.976295% CI: [1, 1.59]Log Rank
Secondary
Change From Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question Have you had pain in your chest? is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.
Time frame: Baseline and up to approximately 60 months
Secondary
Change From Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)
The EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question Have you coughed? is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.
Time frame: Baseline and up to approximately 60 months
Secondary
Change From Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30
The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant response to the question Were you short of breath? is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.
Time frame: Baseline and up to approximately 60 months
Secondary
Change From Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Time frame: Baseline and up to approximately 60 months
Secondary
Change From Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to Items 29 and 30 (How would you rate your overall health during the past week? and How would you rate your overall QoL during the past week?) are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.
Time frame: Baseline and up to approximately 60 months
Secondary
Duration of Response (DOR)
For participants who demonstrated a confirmed Complete Response (CR: disappearance of all lesions) or Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per RECIST 1.1, DOR was defined as the time from first documented CR or PR until progressive disease (PD) or death from any cause, whichever occurs first. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). DOR was calculated using the nonparametric Kaplan-Meier method for censored data.
Time frame: Up to approximately 25 months
Population: Per protocol, the analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized and experienced a CR or PR.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab/Vibostolimab | Duration of Response (DOR) | 4.2 Months |
| Atezolizumab | Duration of Response (DOR) | 3.9 Months |
Secondary
Objective Response Rate (ORR)
ORR was defined as the percentage of participants in the analysis population who have a confirmed Complete Response (CR: disappearance of all lesions) or a Partial Response (PR: ≥30% decrease in the sum of target lesion diameters without progression in other lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR). Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The ORR was calculated using the Miettinen & Nurminen method stratified by baseline ECOG performance status (0 or 1), baseline LDH (≤ or \> upper limit of normal \[ULN\]), and baseline presence of liver metastasis (Yes or No), or brain metastasis (Yes or No).
Time frame: Up to approximately 25 months
Population: Per protocol, the analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pembrolizumab/Vibostolimab | Objective Response Rate (ORR) | 71.7 Percentage of Participants |
| Atezolizumab | Objective Response Rate (ORR) | 74.8 Percentage of Participants |
Comparison: Statistical analyses stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).95% CI: [-11.1, 4.9]
Secondary
Percentage of Participants Who Discontinued Study Treatment Due to an AE
An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time frame: Up to approximately 60 months
Secondary
Percentage of Participants Who Experienced an Adverse Event (AE)
An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Time frame: Up to approximately 60 months
Secondary
Progression-Free Survival (PFS)
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). PFS was calculated using the nonparametric Kaplan-Meier method; participants who did not experience a PFS event were censored at the last disease assessment, or the last assessment before new anticancer treatment if new treatment was initiated. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented.
Time frame: Up to approximately 25 months
Population: Per protocol, the analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pembrolizumab/Vibostolimab | Progression-Free Survival (PFS) | 5.3 Months |
| Atezolizumab | Progression-Free Survival (PFS) | 4.5 Months |
Comparison: Statistical analyses stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).p-value: 0.531695% CI: [0.82, 1.23]Log Rank
Secondary
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of individuals with cancer. Participant responses to Items 29 and 30 (How would you rate your overall health during the past week? and How would you rate your overall QoL during the past week?) are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time frame: Baseline and up to approximately 60 months
Secondary
TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
The EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question Have you had pain in your chest? is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time frame: Baseline and up to approximately 60 months
Secondary
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13
The EORTC QLQ-LC13 is a lung cancer specific health-related QoL questionnaire. Participant response to the question Have you coughed? is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time frame: Baseline and up to approximately 60 months
Secondary
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30
The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant response to the question Were you short of breath? is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time frame: Baseline and up to approximately 60 months
Secondary
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
The EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Time frame: Baseline and up to approximately 60 months