Non-Small Cell Lung Cancer
Conditions
Brief summary
The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.
Interventions
DRUGNivolumab
DRUGIpilimumab
DRUGCarboplatin
DRUGCisplatin
DRUGGemcitabine
DRUGPemetrexed
DRUGPaclitaxel
Sponsors
Ono Pharmaceutical Co. Ltd
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy * Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 * Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria
Exclusion criteria
* Subjects with untreated Central nervous system (CNS) metastases are excluded * Subjects with an active, known or suspected autoimmune disease are excluded * Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival Per BICR | From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks) | Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Overall Survival | From randomization untill death or last follow up whichever occurs first (up to approximately 481 weeks) | OS for all randomized participants is the time between randomization date and the date of death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) Per BICR | From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks) | Objective response rate (ORR) is defined as the number of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale | Week 12 | The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Disease-Related Symptom Deterioration by Week 12 defined as a 10 points or more increase from baseline in LCSS average score at any time (on or off-treatment) up to 95 days from randomization date. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Mexico, Netherlands, Peru, Poland, Romania, Russia, South Africa, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part 1-Arm B: Nivo + Ipi Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity. | 396 |
| Part 1-Arm A: Nivolumab Participants with PD-L1 positive status Non Small Cell Lung Cancer received nivolumab 240 mg intravenously (IV) over 30 minutes every 2 weeks (Q2W) given for up to 24months in the absence of disease progression or unacceptable toxicity. | 396 |
| Part 1-Arm C: Chemotherapy Participants with PD-L1 positive status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy. | 397 |
| Part 1-Arm D: Nivo + Ipi Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes Q6W given for up to 24 months in the absence of disease progression or unacceptable toxicity. | 187 |
| Part 1-Arm G: Nivo + Chemo Participants with PD-L1 negative status Non Small Cell Lung Cancer received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy. | 177 |
| Part 1-Arm F: Chemotherapy Participants with PD-L1 negative status Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy. | 186 |
| Part 2 - Arm H: Nivolumab + Chemotherapy Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received nivolumab 360 mg IV over 30 minutes combined with platinum-doublet chemotherapy administered IV every 3 weeks for a maximum of 4 cycles. Participants who have not experienced disease progression were to receive nivolumab 360 mg every 3weeks until the progression of disease, discontinuation due to toxicity, or up to 24 months (whichever comes first). For subjects with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy. | 377 |
| Part 2 - Arm I: Chemotherapy Chemotherapy-naive participants with stage IV or recurrent NSCLC irrespective of PD-L1 expressing levels received histology-based platinum-doublet chemotherapy IV in 3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy. | 378 |
| Part 3 -Arm J: Nivolumab + Ipilimumab Participants in China with PD-L1 Non Small Cell Lung Cancer received nivolumab 3 mg/kg IV over 30 minutes Q2W + ipilimumab 1 mg/kg over 30minutes every 6 weeks (Q6W) given for up to 24 months in the absence of disease progression or unacceptable toxicity. | 126 |
| Part 3 - Arm K: Chemotherapy Participants in China with PD-L1 Non Small Cell Lung Cancer received histology-based platinum-doublet chemotherapy IV in3-week cycles for a maximum of 4 cycles or until disease progression or unacceptable toxicity (whichever comes first). For participants with NSQ histology, pemetrexed maintenance was allowed until disease progression or unacceptable toxicity after 4 cycles of chemotherapy. | 127 |
| Total | 2,747 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Treatment | Adverse events unrelated to study drug | 0 | 1 | 2 | 1 | 0 | 0 | 1 | 5 | 0 | 0 |
| Pre-Treatment | Death | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Pre-Treatment | Other reasons | 4 | 1 | 4 | 1 | 4 | 2 | 0 | 0 | 0 | 0 |
| Pre-Treatment | Subject no longer meets study criteria | 1 | 2 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
| Pre-Treatment | Subject request to discontinue study treatment | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Pre-Treatment | Subject withdrew consent | 0 | 0 | 3 | 0 | 0 | 1 | 0 | 1 | 0 | 3 |
| Treatment Period | Administrative reason by sponsor | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period | Adverse event unrelated to study drug | 23 | 29 | 22 | 18 | 11 | 15 | 25 | 19 | 4 | 2 |
| Treatment Period | Death | 4 | 7 | 0 | 0 | 1 | 2 | 6 | 5 | 9 | 0 |
| Treatment Period | Disease progression | 212 | 240 | 202 | 93 | 113 | 96 | 208 | 195 | 59 | 46 |
| Treatment Period | Lost to Follow-up | 0 | 0 | 1 | 1 | 0 | 0 | 2 | 2 | 0 | 0 |
| Treatment Period | Maximum Clinical Benefit | 3 | 3 | 1 | 1 | 3 | 0 | 3 | 2 | 2 | 2 |
| Treatment Period | Not reported | 8 | 6 | 4 | 4 | 2 | 1 | 14 | 8 | 5 | 2 |
| Treatment Period | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Treatment Period | Other reasons | 5 | 6 | 12 | 7 | 5 | 1 | 8 | 8 | 21 | 1 |
| Treatment Period | Participant meet no longer study criteria | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 |
| Treatment Period | Participant request to discontinue treatment | 5 | 3 | 15 | 5 | 3 | 6 | 13 | 15 | 4 | 18 |
| Treatment Period | Participant withdrew Consent | 5 | 5 | 3 | 3 | 1 | 3 | 3 | 3 | 2 | 3 |
| Treatment Period | Poor/Non Compliance | 1 | 0 | 2 | 0 | 0 | 1 | 1 | 0 | 0 | 1 |
| Treatment Period | Pregnancy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Treatment Period | Study Drug Toxicity | 79 | 51 | 31 | 39 | 12 | 25 | 52 | 30 | 20 | 9 |
Baseline characteristics
| Characteristic | Part 1-Arm A: Nivolumab | Part 1-Arm C: Chemotherapy | Part 1-Arm D: Nivo + Ipi | Part 1-Arm G: Nivo + Chemo | Part 1-Arm F: Chemotherapy | Part 1-Arm B: Nivo + Ipi | Part 2 - Arm H: Nivolumab + Chemotherapy | Part 2 - Arm I: Chemotherapy | Part 3 -Arm J: Nivolumab + Ipilimumab | Part 3 - Arm K: Chemotherapy | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized < 65 | 210 Participants | 207 Participants | 107 Participants | 91 Participants | 98 Participants | 199 Participants | 214 Participants | 196 Participants | 82 Participants | 84 Participants | 1488 Participants |
| Age, Customized =>65 | 186 Participants | 190 Participants | 80 Participants | 86 Participants | 88 Participants | 197 Participants | 163 Participants | 182 Participants | 44 Participants | 43 Participants | 1259 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 1 Participants | 4 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 13 Participants |
| Race/Ethnicity, Customized Asian | 67 Participants | 82 Participants | 41 Participants | 38 Participants | 45 Participants | 84 Participants | 93 Participants | 94 Participants | 126 Participants | 127 Participants | 797 Participants |
| Race/Ethnicity, Customized Black | 6 Participants | 5 Participants | 0 Participants | 2 Participants | 2 Participants | 4 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 23 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other pacific islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 3 Participants | 1 Participants | 1 Participants | 5 Participants | 5 Participants | 8 Participants | 12 Participants | 0 Participants | 0 Participants | 41 Participants |
| Race/Ethnicity, Customized White | 317 Participants | 305 Participants | 143 Participants | 136 Participants | 133 Participants | 299 Participants | 272 Participants | 266 Participants | 0 Participants | 0 Participants | 1871 Participants |
| Sex: Female, Male Female | 124 Participants | 137 Participants | 49 Participants | 47 Participants | 61 Participants | 141 Participants | 113 Participants | 115 Participants | 18 Participants | 20 Participants | 825 Participants |
| Sex: Female, Male Male | 272 Participants | 260 Participants | 138 Participants | 130 Participants | 125 Participants | 255 Participants | 264 Participants | 263 Participants | 108 Participants | 107 Participants | 1922 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 316 / 391 | 333 / 391 | 339 / 387 | 159 / 185 | 157 / 172 | 174 / 183 | 314 / 375 | 335 / 371 | 95 / 126 | 94 / 123 |
| other Total, other adverse events | 366 / 391 | 356 / 391 | 361 / 387 | 172 / 185 | 167 / 172 | 165 / 183 | 357 / 375 | 345 / 371 | 124 / 126 | 121 / 123 |
| serious Total, serious adverse events | 275 / 391 | 239 / 391 | 213 / 387 | 128 / 185 | 112 / 172 | 91 / 183 | 240 / 375 | 180 / 371 | 78 / 126 | 60 / 123 |
Outcome results
Primary
Overall Survival
OS for all randomized participants is the time between randomization date and the date of death from any cause.
Time frame: From randomization untill death or last follow up whichever occurs first (up to approximately 481 weeks)
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1-Arm B: Nivo + Ipi | Overall Survival | 17.12 months |
| Part 1-Arm A: Nivolumab | Overall Survival | 15.70 months |
| Part 1-Arm C: Chemotherapy | Overall Survival | 14.88 months |
| Part 1-Arm D: Nivo + Ipi | Overall Survival | 17.45 months |
| Part 1-Arm G: Nivo + Chemo | Overall Survival | 15.21 months |
| Part 1-Arm F: Chemotherapy | Overall Survival | 12.19 months |
| Part 2 - Arm H: Nivolumab + Chemotherapy | Overall Survival | 18.27 months |
| Part 2 - Arm I: Chemotherapy | Overall Survival | 14.72 months |
| Part 3 -Arm J: Nivolumab + Ipilimumab | Overall Survival | 20.99 months |
| Part 3 - Arm K: Chemotherapy | Overall Survival | 15.11 months |
95% CI: [0.67, 0.91]
95% CI: [0.78, 1.05]
95% CI: [0.74, 1.01]
95% CI: [0.51, 0.79]
95% CI: [0.63, 0.96]
95% CI: [0.64, 0.87]
95% CI: [0.64, 1.14]
Primary
Progression-Free Survival Per BICR
Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)
Population: All randomized participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1-Arm B: Nivo + Ipi | Progression-Free Survival Per BICR | 5.06 months |
| Part 1-Arm A: Nivolumab | Progression-Free Survival Per BICR | 4.17 months |
| Part 1-Arm C: Chemotherapy | Progression-Free Survival Per BICR | 5.55 months |
| Part 1-Arm D: Nivo + Ipi | Progression-Free Survival Per BICR | 4.90 months |
| Part 1-Arm G: Nivo + Chemo | Progression-Free Survival Per BICR | 5.55 months |
| Part 1-Arm F: Chemotherapy | Progression-Free Survival Per BICR | 4.70 months |
| Part 2 - Arm H: Nivolumab + Chemotherapy | Progression-Free Survival Per BICR | 8.34 months |
| Part 2 - Arm I: Chemotherapy | Progression-Free Survival Per BICR | 5.52 months |
| Part 3 -Arm J: Nivolumab + Ipilimumab | Progression-Free Survival Per BICR | 5.78 months |
| Part 3 - Arm K: Chemotherapy | Progression-Free Survival Per BICR | 5.49 months |
95% CI: [0.67, 0.93]
95% CI: [0.81, 1.12]
95% CI: [0.72, 0.99]
95% CI: [0.6, 0.97]
95% CI: [0.59, 0.93]
95% CI: [0.52, 0.72]
95% CI: [0.49, 0.89]
Secondary
Objective Response Rate (ORR) Per BICR
Objective response rate (ORR) is defined as the number of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)
Population: All randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1-Arm B: Nivo + Ipi | Objective Response Rate (ORR) Per BICR | 36.4 percentage of participants |
| Part 1-Arm A: Nivolumab | Objective Response Rate (ORR) Per BICR | 27.5 percentage of participants |
| Part 1-Arm C: Chemotherapy | Objective Response Rate (ORR) Per BICR | 29.7 percentage of participants |
| Part 1-Arm D: Nivo + Ipi | Objective Response Rate (ORR) Per BICR | 26.2 percentage of participants |
| Part 1-Arm G: Nivo + Chemo | Objective Response Rate (ORR) Per BICR | 37.9 percentage of participants |
| Part 1-Arm F: Chemotherapy | Objective Response Rate (ORR) Per BICR | 23.1 percentage of participants |
| Part 2 - Arm H: Nivolumab + Chemotherapy | Objective Response Rate (ORR) Per BICR | 52.3 percentage of participants |
| Part 2 - Arm I: Chemotherapy | Objective Response Rate (ORR) Per BICR | 29.9 percentage of participants |
| Part 3 -Arm J: Nivolumab + Ipilimumab | Objective Response Rate (ORR) Per BICR | 38.1 percentage of participants |
| Part 3 - Arm K: Chemotherapy | Objective Response Rate (ORR) Per BICR | 30.7 percentage of participants |
Secondary
Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale
The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Disease-Related Symptom Deterioration by Week 12 defined as a 10 points or more increase from baseline in LCSS average score at any time (on or off-treatment) up to 95 days from randomization date.
Time frame: Week 12
Population: All randomized participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1-Arm B: Nivo + Ipi | Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale | 31.3 percentage of participants |
| Part 1-Arm A: Nivolumab | Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale | 35.4 percentage of participants |
| Part 1-Arm C: Chemotherapy | Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale | 25.7 percentage of participants |
| Part 1-Arm D: Nivo + Ipi | Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale | 33.2 percentage of participants |
| Part 1-Arm G: Nivo + Chemo | Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale | 28.8 percentage of participants |
| Part 1-Arm F: Chemotherapy | Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale | 37.6 percentage of participants |
| Part 2 - Arm H: Nivolumab + Chemotherapy | Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale | 30.0 percentage of participants |
| Part 2 - Arm I: Chemotherapy | Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale | 24.3 percentage of participants |
| Part 3 -Arm J: Nivolumab + Ipilimumab | Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale | 23.0 percentage of participants |
| Part 3 - Arm K: Chemotherapy | Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale | 26.0 percentage of participants |