M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)

• Status: Active, not recruiting
• Trial end date: 2022-01-28
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of the study is to evaluate the safety and tolerability of M7824 in combination with chemotherapy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborator: Merck KGaA, Darmstadt, Germany
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Docetaxel; Gemcitabine; Paclitaxel; Pemetrexed

Criteria

Inclusion Criteria:

• Participants greater than or equals to (>=) 18 years of age inclusive at the time of signing the informed consent

• Participants who have histologically confirmed diagnosis of Stage IV NSCLC:

1. Participants in Cohort A, B, and C must not have received prior systemic therapy treatment for their Stage IV NSCLC

2. Participants who had disease progression on previous treatment with Programmed death-ligand 1 (PD- L1) inhibitors in combination with platinum-based chemotherapy are enrolled in Cohort D, as long as therapy was completed at least 28 days of the first study intervention.

• Have measurable disease based on Response evaluation criteria in solid tumors (RECIST) 1.1

• Have a life expectancy of at least 3 months

• Availability of archived tumor material (less than [<] 6 months old) adequate for biomarker analysis is mandatory at Screening, central laboratory confirmation is required. Fresh biopsies should be collected if archived tumor material is not available

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at study entry and date of first dose

Exclusion Criteria:

• The participant's tumor harbors an epidermal growth factor receptor (EGFR) sensitizing (activating) mutation,ROS1 rearrangement, or BRAF V600E mutation or anaplastic lymphoma kinase (ALK) positive, if targeted therapy is locally approved

• Mixed small cell with NSCLC cancer histology

• Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy (RT) of > 30 gray (Gy) within 6 months prior to the first dose of study intervention

• Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years

• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks after the end of the RT and, have no evidence of new or enlarging brain metastases evaluated by imaging, preferably brain magnetic resonance imaging (MRI)

• Known severe hypersensitivity to study intervention or any components in their formulations

• For participants in Cohort A, B and C: Has received prior systemic therapy for Stage IV NSCLC, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)

• Unable to tolerate computed tomography (CT) or MRI in the opinion of the Investigator and/or allergy to contrast material.