A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater than or Equal to 50% (TroFuse-007)

Conditions

Metastatic non-small cell lung cancer (NSCLC)

Brief summary

Overall Survival (OS)

Detailed description

Progression free survival (PFS), Objective Response (OR), Duration of Response (DOR), Change from Baseline in Global Health Status/Quality of Life (QOL) Score [European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) Items 29 and 30], Change From Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8), Change From Baseline in Cough Score (EORTC QLQ-LC13 Item 31), Change From Baseline in Chest Pain Score (EORTC QLQ-LC13 Item 40), Time to Deterioration (TTD) Based on Change from Baseline in Global Health Status (GHS)/ QOL Score (EORTC QLQ-C30 Items 29 and 30), TTD Based on Change from Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8), TTD Based on Change from Baseline in Cough Score (EORTC QLQ-LC13 Item 31), TTD Based on Change from Baseline in Chest Pain Score (EORTC QLQ-LC13 Item 40), Percentage of Participants that Experience at Least One Adverse Event (AE), Percentage of Participants who Discontinue Study Treatment Due to an AE

Related papers

No related papers found yet.

Interventions

DRUG-

DRUGMK-2870

DRUGDEXAMETHASONE

DRUGPARACETAMOL

DRUGCOMBINATIONS EXCL. PSYCHOLEPTICS

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS)	—

Secondary

Measure	Time frame
Progression free survival (PFS), Objective Response (OR), Duration of Response (DOR), Change from Baseline in Global Health Status/Quality of Life (QOL) Score [European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) Items 29 and 30], Change From Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8), Change From Baseline in Cough Score (EORTC QLQ-LC13 Item 31), Change From Baseline in Chest Pain Score (EORTC QLQ-LC13 Item 40), Time to Deterioration (TTD) Based on Change from Baseline in Global Health Status (GHS)/ QOL Score (EORTC QLQ-C30 Items 29 and 30), TTD Based on Change from Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8), TTD Based on Change from Baseline in Cough Score (EORTC QLQ-LC13 Item 31), TTD Based on Change from Baseline in Chest Pain Score (EORTC QLQ-LC13 Item 40), Percentage of Participants that Experience at Least One Adverse Event (AE), Percentage of Participants who Discontinue Study Treatment Due to an AE	—

Measure

Time frame

Progression free survival (PFS), Objective Response (OR), Duration of Response (DOR), Change from Baseline in Global Health Status/Quality of Life (QOL) Score [European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) Items 29 and 30], Change From Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8), Change From Baseline in Cough Score (EORTC QLQ-LC13 Item 31), Change From Baseline in Chest Pain Score (EORTC QLQ-LC13 Item 40), Time to Deterioration (TTD) Based on Change from Baseline in Global Health Status (GHS)/ QOL Score (EORTC QLQ-C30 Items 29 and 30), TTD Based on Change from Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8), TTD Based on Change from Baseline in Cough Score (EORTC QLQ-LC13 Item 31), TTD Based on Change from Baseline in Chest Pain Score (EORTC QLQ-LC13 Item 40), Percentage of Participants that Experience at Least One Adverse Event (AE), Percentage of Participants who Discontinue Study Treatment Due to an AE

—

Countries

Czechia, Denmark, France, Germany, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed