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Immunotherapy

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

Phase 2

Waitlist Available

Research Sponsored by EMD Serono Research & Development Institute, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from randomization up to data cut off (assessed up to 27 months)

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

Summary

This trial is testing whether adding a new drug called M7824 to standard chemoradiation therapy can improve patient outcomes compared to using another drug called durvalumab. The study focuses on patients receiving chemoradiation therapy. Both M7824 and durvalumab are designed to help the immune system better fight cancer. Durvalumab has been approved for treating advanced urothelial and non-small cell lung cancers and is being explored in other cancers.

Eligible Conditions

Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from randomization up to data cut off (assessed up to 27 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from randomization up to data cut off (assessed up to 27 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from randomization up to data cut off (assessed up to 27 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator

Secondary study objectives

Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator

Immediate Observed Serum Concentration at End of Infusion (Ceoi) of M7824

Number of Participants With Positive Antidrug Antibodies (ADA)

+4 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: cCRT plus M7824 followed by M7824Experimental Treatment7 Interventions

Participants received cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with M7824 followed by M7824.

Group II: cCRT plus placebo followed by durvalumabActive Control8 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

FDA approved

Carboplatin

FDA approved

Pemetrexed

FDA approved

Intensity Modulated Radiation Therapy (IMRT)

2010