Description:
The main purpose of this study is 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.
Title
- Brief Title: M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)
- Official Title: A Multicenter, Double Blind, Randomized, Controlled Study of M7824 With Concurrent Chemoradiation Followed by M7824 Versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants With Unresectable Stage III Non-small Cell Lung Cancer
Clinical Trial IDs
- ORG STUDY ID:
MS200647_0005
- SECONDARY ID:
2018-003265-34
- NCT ID:
NCT03840902
Conditions
- Non-small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
M7824 | | Arm 1: cCRT plus M7824 followed by M7824 |
Placebo | | Arm 2: cCRT plus placebo followed by durvalumab |
Durvalumab | | Arm 2: cCRT plus placebo followed by durvalumab |
Etoposide | | Arm 1: cCRT plus M7824 followed by M7824 |
Pemetrexed | | Arm 1: cCRT plus M7824 followed by M7824 |
Carboplatin | | Arm 1: cCRT plus M7824 followed by M7824 |
Paclitaxel | | Arm 1: cCRT plus M7824 followed by M7824 |
Cisplatin | | Arm 1: cCRT plus M7824 followed by M7824 |
Purpose
The main purpose of this study is 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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm 1: cCRT plus M7824 followed by M7824 | Experimental | Participants will receive cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with M7824 followed by M7824. | - M7824
- Etoposide
- Pemetrexed
- Carboplatin
- Paclitaxel
- Cisplatin
|
Arm 2: cCRT plus placebo followed by durvalumab | Active Comparator | Participants will receive 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. | - Placebo
- Durvalumab
- Etoposide
- Pemetrexed
- Carboplatin
- Paclitaxel
- Cisplatin
|
Eligibility Criteria
Inclusion Criteria:
- Participants must have histologically documented NSCLC who present with Stage III
locally advanced, unresectable disease (International Association for the Study of
Lung Cancer Staging Manual in Thoracic Oncology
- Participants with tumor harboring an Epidermal growth factor receptor (EGFR)
sensitizing (activating) mutation, Anaplastic lymphoma kinase (ALK) translocation,
ROS-1 rearrangement are eligible.
- Participants must have adequate pulmonary function defined as a forced expiratory
volume in 1 second (FEV1) greater than equals to (>=) 1.2 liters or >= 50% of
predicted normal volume measured within 3 weeks prior to randomization.
- Adequate hematological, hepatic and renal function as defined in the protocol
- Contraceptive use by males or females will be consistent with local regulations on
contraception methods for those participating in clinical studies
Exclusion Criteria:
- Participants with Mixed small cell with non-small cell lung cancer histology
- Recent major surgery within 4 weeks prior to entry into the study
- Significant acute or chronic infections including human immunodeficiency virus (HIV)
or known acquired immunodeficiency syndrome, Active hepatitis B virus (HBV) or
hepatitis C virus (HCV) infection and active tuberculosis
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness
requiring hospitalization
- Active autoimmune disease that has required systemic treatment in past 1 year (i.e.,
with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)
- Any prior systemic cytotoxic chemotherapy for their NSCLC or any antibody or drug
targeting T-cell coregulatory proteins
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) Assessed by Independent Review Committee (IRC) |
Time Frame: | Time from first dose up to 59 Months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Occurrence of Treatment Emergent Adverse Events (TEAEs) and Treatment-related AEs |
Time Frame: | Baseline up to 8.8 years |
Safety Issue: | |
Description: | |
Measure: | Overall Survival |
Time Frame: | Baseline up to 8.8 years |
Safety Issue: | |
Description: | |
Measure: | Changes from Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO) |
Time Frame: | Baseline up to 14 months |
Safety Issue: | |
Description: | |
Measure: | Programmed death-ligand 1 (PD-L1) Expression in Tumors Assessed with Immunohistochemistry (IHC) and Association with Efficacy |
Time Frame: | Baseline up to 8.8 years |
Safety Issue: | |
Description: | |
Measure: | Objective Response According to RECIST 1.1 Assessed by IRC |
Time Frame: | Baseline up to 8.8 years |
Safety Issue: | |
Description: | |
Measure: | Duration of Response According to RECIST 1.1 |
Time Frame: | Baseline up to 8.8 years |
Safety Issue: | |
Description: | |
Measure: | Immunogenicity of M7824 as Measured by Antidrug Antibody (ADA) Assays |
Time Frame: | Baseline up to 8.8 years |
Safety Issue: | |
Description: | |
Measure: | Concentration Immediately Before Next Dosing (Ctrough) |
Time Frame: | Baseline up to 14 months |
Safety Issue: | |
Description: | |
Measure: | Concentration Immediately at End of Infusion (Ceoi) |
Time Frame: | Baseline up to 14 months |
Safety Issue: | |
Description: | |
Measure: | Changes from Baseline in High-resolution Computed Tomography (HRCT) |
Time Frame: | Baseline up to 14 months |
Safety Issue: | |
Description: | |
Measure: | Changes from Baseline in Forced Expiratory Volume in one Second (FEV1) |
Time Frame: | Baseline up to 14 months |
Safety Issue: | |
Description: | |
Measure: | Changes from Baseline in Forced Vital Capacity (FVC) |
Time Frame: | Baseline up to 14 months |
Safety Issue: | |
Description: | |
Measure: | Changes from Baseline in 6-minutes Walking Test |
Time Frame: | Baseline up to 14 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | EMD Serono Research & Development Institute, Inc. |
Trial Keywords
- Non-small Cell Lung Cancer
- Bintrafusp alfa (proposed INN)
- M7824
- Durvalumab
- Stage III
- INTR@PID LUNG 005
Last Updated
January 5, 2021