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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

April 2, 2019

Primary Completion Date

July 29, 2022

Study Completion Date

July 29, 2022

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
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).

Trial Locations (19)

20817

RCCA MD LLC - Bethesda, Bethesda

21201

University of Maryland - DUPLICATE/Pediatric Surgery, Baltimore

34952

Hematology - Oncology Associates of Treasure Coast - Hematology-Oncology Associates of Treasure Coast, Port Saint Lucie

40503

Baptist Health Lexington Oncology Associates, Lexington

48202

Henry Ford Health System, Detroit

92069

California Cancer Associates for Research & Excellence, Inc., San Marcos

92708

Compassionate Care Research Group Inc - Edinger Medical Group, Inc., Fountain Valley

37232-8805

Vanderbilt University Medical Center, Nashville

Unknown

Universitair Ziekenhuis Brussel - Geriatrie, Brussels

UZ Antwerpen, Edegem

Universitair Ziekenhuis Gent - Medical Oncology, Ghent

CHU Sart Tilman, Liège

AZ Sint-Maarten, Mechelen

Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha, Bordeaux

Centre Georges François Leclerc - Unité de Phase I, Dijon

Hôpital de la Timone# - CPCEM CIC - Bat F 1er étage, Marseille

ICO - Site René Gauducheau, Nantes

Centre Antoine Lacassagne, Nice

CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale, Poitiers

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY

NCT03840915 - M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC) | Biotech Hunter | Biotech Hunter