Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Clinical summary
Summary
All patients eligible to participate in this trial will receive cCRT, which involves intravenous administration of Cisplatin/Etoposide or Carboplatin/Paclitaxel or Cisplatin/Pemetrexed along with radiation therapy. In addition patients will either receive M7824 during and after cCRT, or a placebo during and another immunotherapy (Durvalumab) after the cCRT.
Conditions
This trial is treating people with inoperable, Stage III non-small cell lung cancer
Eligibility
Inclusion
- 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
- 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
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
EMD Serono
Scientific 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
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