M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: M7824; Placebo; Durvalumab; Etoposide; Pemetrexed; Carboplatin; Paclitaxel; Cisplatin; Intensity Modulated Radiation Therapy (IMRT)
Intervention description: 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.; Participants received intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.; 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.; 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.; Participants received pemetrexed at a dose of 500 mg/m^2 intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT.; Participants received carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT.; Participants received paclitaxel intravenously at a dose of 45 mg/m^2 over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT.; In combination with etoposide, participants received cisplatin 50 mg/m^2 intravenously over 60 minutes on Days 1, 8, 29, and 36 during cCRT. In combination with pemetrexed, participants received cisplatin 75 mg/m2 intravenously over 60 minutes on Days 1, 22, and 43 during cCRT.; Participants received IMRT 5 fractions per week for about 6 weeks (Total 60 gray [Gy]).
Intervention MeSH terms: Paclitaxel; Etoposide; Carboplatin; Pemetrexed; Durvalumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-small Cell Lung Cancer; Bintrafusp alfa (proposed INN); M7824; Durvalumab; Stage III; INTR@PID LUNG 005

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.
    

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