Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Durvalumab | Drug | Durvalumab | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Intensity Modulated Radiation Therapy (IMRT) | Radiation | — | UNRESOLVED |
| M7824 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Placebo |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- cCRT plus M7824 followed by M7824
- description
- Participants received cCRT: Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed concomitant with Intensity Modulated Radiation Therapy (IMRT) along with M7824 followed by M7824.
- interventionNames
- Drug: M7824
- Drug: Etoposide
- Drug: Pemetrexed
- Drug: Carboplatin
- Drug: Paclitaxel
- Drug: Cisplatin
- Radiation: Intensity Modulated Radiation Therapy (IMRT)
- type
- ACTIVE_COMPARATOR
- label
- cCRT plus placebo followed by durvalumab
- description
- 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.
- interventionNames
- Drug: Placebo
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHuang Y, Zhao JJ, Soon YY, Wong A, Aminkeng F, Ang Y, Asokumaran Y, Low JL, Lee M, Choo JRE, Chan G, Kee A, Tay SH, Goh BC, Soo RA. Real-world experience of consolidation durvalumab after concurrent chemoradiotherapy in stage III non-small cell lung cancer. Thorac Cancer. 2022 Nov;13(22):3152-3161. doi: 10.1111/1759-7714.14667. Epub 2022 Sep 30. PMID 36177913