A Phase 3 Study of Pembrolizumab in Combination with Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants with Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC)

Conditions

Stage IV lung cancer condition

Brief summary

Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST 1.1), Overall Survival (OS)

Detailed description

Number of Participants Experiencing an Adverse Event (AE), Number of Participants Discontinuing Study Treatment Due to Adverse Event (AE), Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC)Quality of Life Questionnaire-Core 30 (QLQ-C30) GlobalHealth Status /Quality of Life(Items 29 and30) Scale Score, Change from Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score, Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score, Change from Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score, Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score, Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 & 30) Scale Score, Time to True Deterioration (TTD) in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score, Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score, Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item8) Scale Score, Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score

Related papers

No related papers found yet.

Interventions

DRUGOlaparib

DRUGCISPLATIN

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGPEMETREXED

DRUGCARBOPLATIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST 1.1), Overall Survival (OS)	—

Secondary

Measure	Time frame
Number of Participants Experiencing an Adverse Event (AE), Number of Participants Discontinuing Study Treatment Due to Adverse Event (AE), Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC)Quality of Life Questionnaire-Core 30 (QLQ-C30) GlobalHealth Status /Quality of Life(Items 29 and30) Scale Score, Change from Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score, Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score, Change from Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score, Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score, Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 & 30) Scale Score, Time to True Deterioration (TTD) in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score, Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pa	—

Measure

Time frame

Number of Participants Experiencing an Adverse Event (AE), Number of Participants Discontinuing Study Treatment Due to Adverse Event (AE), Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC)Quality of Life Questionnaire-Core 30 (QLQ-C30) GlobalHealth Status /Quality of Life(Items 29 and30) Scale Score, Change from Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score, Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score, Change from Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score, Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score, Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 & 30) Scale Score, Time to True Deterioration (TTD) in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score, Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pa

—

Countries

Austria, France, Germany, Poland, Romania, Spain

Outcome results

None listed