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

Part of paid clinical trials in Orange, California.

Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID
NCT03840902
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • M7824 — DRUG
    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.
  • Placebo — DRUG
    Participants received intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
  • Durvalumab — DRUG
    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.
  • Etoposide — DRUG
    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.
  • Pemetrexed — DRUG
    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.
  • Carboplatin — DRUG
    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.
  • Paclitaxel — DRUG
    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.
  • Cisplatin — DRUG
    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.
  • Intensity Modulated Radiation Therapy (IMRT) — RADIATION
    Participants received IMRT 5 fractions per week for about 6 weeks (Total 60 gray \[Gy\]).

Study Details

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.

Key Dates

Start date
Apr 16, 2019
Status verified
Jan 2024
Primary completion
Feb 17, 2023
Completion
Feb 17, 2023

Study Design

Enrollment
153 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: cCRT plus M7824 followed by M7824
    Participants received cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with M7824 followed by M7824.
  • Active Comparator: cCRT plus placebo followed by durvalumab
    Participants received cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with placebo matched to M7824 followed by durvalumab.

Primary Outcome Measure

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator [ Time Frame: Time from randomization to the date of first documentation of PD or death, assessed approximately up to 27 months ]

Locations (21)

FacilityCityStateZIPSite coordinators
University of California Irvine Medical CenterOrangeCalifornia92868-
UCLA Hematology Oncology - Main Site - 2020 Santa MonicaSanta MonicaCalifornia90404-
University of Colorado Health - Memorial Hospital - Memorial HospitalColorado SpringsColorado80909-
Hematology Oncology AssociatesFort CollinsColorado80528-
Lynn Cancer Institute CenterBoca RatonFlorida33486-
Holy Cross Hospital - Michael and Dianne Bienes CCCFort LauderdaleFlorida33308-
Sylvester Comprehensive Cancer Center - University of Miami Health SystemMiamiFlorida33136-
The University of Chicago Medical CenterChicagoIllinois60637-
American Health Network of Indiana, LLCIndianapolisIndiana46202-
Franciscan St. Francis Health Cancer CenterIndianapolisIndiana46237-
Baptist Health Lexington Oncology AssociatesLexingtonKentucky40503-
University of Maryland - DUPLICATE/Pediatric SurgeryBaltimoreMaryland21201-
Henry Ford Health SystemDetroitMichigan48202-
Mayo ClinicRochesterMinnesota55902-
Columbia University Medical CenterNew YorkNew York10032-
Hematology Oncology Center of Nyack HospitalNyackNew York10960-
FirstHealth of the Carolinas, Inc.PinehurstNorth Carolina28374-
The James Cancer Hospital and Solove Research InstituteColumbusOhio43210-
UPMC Cancer CenterPittsburghPennsylvania15232-
Vanderbilt University Medical CenterNashvilleTennessee37232-
University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical OncologyHoustonTexas77030-

Find similar trials in Orange, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of California Irvine Medical Center· Orange, CAUCLA Hematology Oncology - Main Site - 2020 Santa Monica· Santa Monica, CAUniversity of Colorado Health - Memorial Hospital - Memorial Hospital· Colorado Springs, COHematology Oncology Associates· Fort Collins, COLynn Cancer Institute Center· Boca Raton, FLHoly Cross Hospital - Michael and Dianne Bienes CCC· Fort Lauderdale, FL

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