NCT03840915

M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)

A Phase Ib/II, Open-Label Study of M7824 in Combination With Chemotherapy in Participants With Stage IV Non-small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the study was to evaluate the safety and tolerability of M7824 in combination with chemotherapy.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Cisplatin	Cisplatin was administered intravenously at a dose of 75 milligrams per meter square (mg/m\^2) over 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
DRUG	Carboplatin	Carboplatin was administered at area under the concentration-time Curve (AUC) 5 when combined with pemetrexed over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
DRUG	Pemetrexed	Pemetrexed was administered intravenously at a dose of 500 mg/ m\^2 over 10 minutes every 21 days.
DRUG	Nab-paclitaxel	Nab-paclitaxel was administered intravenously at as dose of 100 mg/m\^2 over 30 minutes in a 21 days cycle on Day 1, 8, and 15 in each cycle for 4 cycles (each cycle is 21 days).
DRUG	Gemcitabine	Gemcitabine was administered intravenously at a dose of 1250 mg/m\^2 over 30 minutes in a 21 days cycle on Day 1, and 8, in each cycle for 4 cycles (each cycle is 21 days).
DRUG	Docetaxel	Docetaxel was administered intravenously at a dose of 75 mg/m\^2 over 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
DRUG	M7824	M7824 was administered intravenously at a dose of 2400 mg every 21 days in combination with chemotherapy for 4 cycles (each cycle is 21 days) followed by up to 31 cycles in maintenance with M7824 and pemetrexed.
DRUG	Carboplatin	Carboplatin was administered at area under the concentration-time Curve (AUC) 6 when combined with nab-paclitaxel over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
DRUG	Carboplatin	Carboplatin was administered at area under the concentration-time Curve (AUC) 5 when combined with gemcitabine over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
DRUG	Bintrafusp alfa	M7824 was administered intravenously at a dose of 2400 mg every 21 days in combination with chemotherapy for 4 cycles (each cycle is 21 days) followed by up to 31 cycles in maintenance with M7824 alone.
DRUG	Paclitaxel	Paclitaxel was administered intravenously at a dose of 200 mg/m2 over 3 hours every 3 weeks for 4 cycles (each cycle is 21 days).

Timeline

• Start date: 2019-04-02
• Primary completion: 2022-07-29
• Completion: 2022-07-29
• First posted: 2019-02-15
• Last updated: 2023-08-21
• Results posted: 2023-08-21

Locations

19 sites across 3 countries: United States, Belgium, France

Regulatory

• FDA-regulated drug study