A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer

Conditions

Participants with treatment-naïve metastatic squamous Non-small Cell Lung Cancer (NSCLC)

Brief summary

Overall survival (OS)

Detailed description

Progression-Free Survival (PFS), Number of Participants With One or More Adverse Events (AEs), Number of Participants Discontinuing from Study Therapy Due to AE(s), Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Global health status/Quality of Life (QoL) Score (EORTC QLQ-C30 Items 29 and 30), Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Dyspnea (EORTC QLQ-C30 Item 8), Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Cough (EORTC QLQ-LC13 Item 31), Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Chest Pain (EORTC QLQ-LC13 Item 40), Time to First Deterioration (TTD) in Global Health Status/QoL Scores (EORTC QLQ-C30 Items 29 and 30), TTD in Dyspnea Score (EORTC QLQ-C30 Item 8), TTD in Cough Score (EORTC QLQ-LC13 Item 31), TTD in Chest Pain Score (EORTC QLQ-LC13 Item 40)

Related papers

No related papers found yet.

Interventions

DRUG-

DRUGDEXAMETHASONE

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGCARBOPLATIN

DRUGPARACETAMOL

DRUGMK-2870

DRUGPACLITAXEL ALBUMIN-BOUND

DRUGPACLITAXEL

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), Number of Participants With One or More Adverse Events (AEs), Number of Participants Discontinuing from Study Therapy Due to AE(s), Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Global health status/Quality of Life (QoL) Score (EORTC QLQ-C30 Items 29 and 30), Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Dyspnea (EORTC QLQ-C30 Item 8), Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Cough (EORTC QLQ-LC13 Item 31), Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Chest Pain (EORTC QLQ-LC13 Item 40), Time to First Deterioration (TTD) in Global Health Status/QoL Scores (EORTC QLQ-C30 Items 29 and 30), TTD in Dyspnea Score (EORTC QLQ-C30 Item 8), TTD in Cough Score (EORTC QLQ-LC13 Item 31), TTD in Chest Pain Score (EORTC QLQ-LC13 Item 40)	—

Measure

Time frame

Progression-Free Survival (PFS), Number of Participants With One or More Adverse Events (AEs), Number of Participants Discontinuing from Study Therapy Due to AE(s), Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Global health status/Quality of Life (QoL) Score (EORTC QLQ-C30 Items 29 and 30), Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Dyspnea (EORTC QLQ-C30 Item 8), Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Cough (EORTC QLQ-LC13 Item 31), Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Chest Pain (EORTC QLQ-LC13 Item 40), Time to First Deterioration (TTD) in Global Health Status/QoL Scores (EORTC QLQ-C30 Items 29 and 30), TTD in Dyspnea Score (EORTC QLQ-C30 Item 8), TTD in Cough Score (EORTC QLQ-LC13 Item 31), TTD in Chest Pain Score (EORTC QLQ-LC13 Item 40)

—

Countries

Austria, Czechia, France, Germany, Hungary, Ireland, Italy, Poland, Romania, Spain

Outcome results

None listed