NCT03840902

M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

A Multicenter, Double Blind, Randomized, Controlled Study of M7824 With Concurrent Chemoradiation Followed by M7824 Versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants With Unresectable Stage III Non-small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study was to evaluate safety and efficacy in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	M7824	Participants received intravenous infusion of 1200 milligram (mg) M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
DRUG	Placebo	Participants received intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
DRUG	Durvalumab	Participants received intravenous infusion of durvalumab 10 milligram per kilogram (mg/Kg) over 1 hour q2w up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
DRUG	Etoposide	Participants received etoposide 50 mg/m\^2 intravenously over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT.
DRUG	Pemetrexed	Participants received pemetrexed at a dose of 500 mg/m\^2 intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT.
DRUG	Carboplatin	Participants received carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT.
DRUG	Paclitaxel	Participants received paclitaxel intravenously at a dose of 45 mg/m\^2 over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT.
DRUG	Cisplatin	In combination with etoposide, participants received cisplatin 50 mg/m\^2 intravenously over 60 minutes on Days 1, 8, 29, and 36 during cCRT. In combination with pemetrexed, participants received cisplatin 75 mg/m2 intravenously over 60 minutes on Days 1, 22, and 43 during cCRT.
RADIATION	Intensity Modulated Radiation Therapy (IMRT)	Participants received IMRT 5 fractions per week for about 6 weeks (Total 60 gray \[Gy\]).

Timeline

• Start date: 2019-04-16
• Primary completion: 2023-02-17
• Completion: 2023-02-17
• First posted: 2019-02-15
• Last updated: 2024-01-16
• Results posted: 2024-01-16

Locations

104 sites across 15 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Japan, Netherlands, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study