NCT03840902|TerminatedPhase 2ResultsDMCFDA Drug

Study Stopped

Based on recommendations by an external Independent data Monitoring Committee (IDMC), Sponsor decided to discontinue this clinical study due to a low likelihood of achieving superiority in the efficacy endpoints versus standard of care.

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

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

EMD Serono Research & Development Institute, Inc.ClinicalTrials.gov

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2 other identifiers

MS200647_00052018-003265-34

Study Type

interventional

Target

153

Locations

15 countries

Sites

104

Timeline

RegisteredFeb 2019

StartedApr 2019

CompletionFeb 2023

Brief Summary

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

153

participants targeted

Target at P75+ for phase_2 nonsmall-cell-lung-cancer

Timeline

Completed

Started Apr 2019

Typical duration for phase_2 nonsmall-cell-lung-cancer

Geographic Reach

15 countries

104 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.8 years study duration

First Submitted

Initial submission to the registry

February 12, 2019

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed

2 months until next milestone

Study Start

First participant enrolled

April 16, 2019

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2023

Completed

11 months until next milestone

Results Posted

Study results publicly available

January 16, 2024

Completed

Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

3.8 years

First QC Date

February 12, 2019

Results QC Date

December 5, 2023

Last Update Submit

January 12, 2024

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung CancerBintrafusp alfa (proposed INN)M7824DurvalumabStage IIIINTR@PID LUNG 005

Outcome Measures

Primary Outcomes (1)

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator
PFS was defined as the time from randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was analyzed by using the Kaplan-Meier method.
Time from randomization to the date of first documentation of PD or death, assessed approximately up to 27 months

Secondary Outcomes (7)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events
Time from randomization up to data cut off (assessed up to 27 months)
Overall Survival (OS)
Time from randomization to the date of death due to any cause, assessed up to 27 months
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator
Time from randomization up to data cut off (assessed up to 27 months)
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator
Time from first documentation of objective response to the date of first documentation of PD or death due to any cause, assessed approximately up to 27 months
Immediate Observed Serum Concentration at End of Infusion (Ceoi) of M7824
Pre-dose, 30 minutes after end of infusion on Day 1, 15, 29, 57, 85, 127, 157, 343
+2 more secondary outcomes

Study Arms (2)

cCRT plus M7824 followed by M7824

EXPERIMENTAL

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

Drug: M7824Drug: EtoposideDrug: PemetrexedDrug: CarboplatinDrug: PaclitaxelDrug: CisplatinRadiation: Intensity Modulated Radiation Therapy (IMRT)

cCRT plus placebo followed by durvalumab

ACTIVE COMPARATOR

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.

Drug: PlaceboDrug: DurvalumabDrug: EtoposideDrug: PemetrexedDrug: CarboplatinDrug: PaclitaxelDrug: CisplatinRadiation: Intensity Modulated Radiation Therapy (IMRT)

Interventions

M7824DRUG

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.

cCRT plus M7824 followed by M7824

PlaceboDRUG

Participants received intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.

cCRT plus placebo followed by durvalumab

DurvalumabDRUG

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.

cCRT plus placebo followed by durvalumab

EtoposideDRUG

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.