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

Phase 2 Terminated 153 enrolled EMD Serono Research & Development Institute, Inc. Merck KGaA, Darmstadt, Germany · collab

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2019-04-16
Primary completion: 2023-02-17
Completion: 2023-02-17

Outcome

Outcome not reported

Stopped: “Based on recommendations by an external Independent data Monitoring Committee (IDMC), Sponsor decided to discontinue this clinical study due to a low likelihood of achieving superiority in the efficacy endpoints versus standard of care.”

Publications

Huang Y, Zhao JJ, Soon YY, Wong A, Aminkeng F, Ang Y, Asokumaran Y, Low JL, Lee M, Choo JRE, Chan G, Kee A, Tay SH, Goh BC, Soo RA. Real-world experience of consolidation durvalumab after concurrent chemoradiotherapy in stage III non-small cell lung cancer. Thorac Cancer. 2022 Nov;13(22):3152-3161. doi: 10.1111/1759-7714.14667. Epub 2022 Sep 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bintrafusp alfa	Protein / enzyme biologic	1200 mg	Intravenous
Comparator	Durvalumab	Monoclonal antibody	10 mg/kg	Intravenous
Background	Carboplatin	Small molecule	2 unknown	Intravenous
Background	Cisplatin	Other / unclassified	50 mg/m2	Intravenous
Background	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Background	Etoposide	Small molecule	50 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	45 mg/m2	Intravenous
Background	Pemetrexed	Small molecule	500 mg/m2	Intravenous