A Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants with EGFR-mutated, Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors

Conditions

Non-small Cell Lung Cancer (NSCLC)

Brief summary

Progression-free survival (PFS), Overall survival (OS)

Detailed description

Objective response rate (ORR), Duration of response (DOR), Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) global health status (Item 29) and quality of life (Item 30) combined score, Change from baseline in the dyspnea (item 8) score, on the EORTC QLQ-C30, Change from baseline in the cough (item 31) score, on the EORTC Lung-Cancer specific Quality of Life Questionnaire (QLQ-LC13), Change from baseline in the chest pain (item 40) score, on the EORTC QLQ-LC13, Time to deterioration (TTD) in global health status/quality of life (items 29 and 30) score, on the EORTC-QLQ-C30, TTD in the dyspnea (item 8) score, on the EORTC QLQ-C30, TTD in the cough (item 31) score, on the EORTC QLQ-LC13, TTD in the chest pain (item 40) score, on the EORTC QLQ-LC13, Number of participants who experience one or more adverse events (AEs), Number of participants who discontinue study treatment due to an AE

Related papers

No related papers found yet.

Interventions

DRUG-

DRUGCARBOPLATIN

DRUGMK-2870

DRUGPEMETREXED

DRUGPARACETAMOL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS), Overall survival (OS)	—

Secondary

Measure	Time frame
Objective response rate (ORR), Duration of response (DOR), Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) global health status (Item 29) and quality of life (Item 30) combined score, Change from baseline in the dyspnea (item 8) score, on the EORTC QLQ-C30, Change from baseline in the cough (item 31) score, on the EORTC Lung-Cancer specific Quality of Life Questionnaire (QLQ-LC13), Change from baseline in the chest pain (item 40) score, on the EORTC QLQ-LC13, Time to deterioration (TTD) in global health status/quality of life (items 29 and 30) score, on the EORTC-QLQ-C30, TTD in the dyspnea (item 8) score, on the EORTC QLQ-C30, TTD in the cough (item 31) score, on the EORTC QLQ-LC13, TTD in the chest pain (item 40) score, on the EORTC QLQ-LC13, Number of participants who experience one or more adverse events (AEs), Number of participants who discontinue study treatment due to an AE	—

Measure

Time frame

Objective response rate (ORR), Duration of response (DOR), Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) global health status (Item 29) and quality of life (Item 30) combined score, Change from baseline in the dyspnea (item 8) score, on the EORTC QLQ-C30, Change from baseline in the cough (item 31) score, on the EORTC Lung-Cancer specific Quality of Life Questionnaire (QLQ-LC13), Change from baseline in the chest pain (item 40) score, on the EORTC QLQ-LC13, Time to deterioration (TTD) in global health status/quality of life (items 29 and 30) score, on the EORTC-QLQ-C30, TTD in the dyspnea (item 8) score, on the EORTC QLQ-C30, TTD in the cough (item 31) score, on the EORTC QLQ-LC13, TTD in the chest pain (item 40) score, on the EORTC QLQ-LC13, Number of participants who experience one or more adverse events (AEs), Number of participants who discontinue study treatment due to an AE

—

Countries

France, Italy, Poland, Spain, Sweden

Outcome results

None listed