Study of Avelumab and Cetuximab Plus Gemcitabine and Cisplatin in Participants With NSCLC

• Status: Completed
• Trial end date: 2021-05-27
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of the study was to investigate the clinical activity and safety of avelumab in combination with cetuximab plus gemcitabine and cisplatin in participants with treatment-naïve advanced squamous (NSCLC).

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

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Antibodies, Monoclonal; Avelumab; Carboplatin; Cetuximab; Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

• Histologically-confirmed Stage IV metastatic or recurrent (Stage IV) NSCLC of squamous histology

• Availability of formalin-fixed paraffin-embedded (FFPE) block containing tumor tissue or a minimum of 15 (preferably 25) unstained tumor slides (cut within 1 week) suitable for Programmed death ligand 1 (PD-L1) expression and epidermal growth factor receptor (EGFR) expression/amplification assessments

• At least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) v1.1 criteria

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

• Adequate hematological, hepatic and renal function

• Estimated life expectancy of at least 3 months

• Can give signed informed consent

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Participants whose tumor disease harbors an activating EGFR mutation or ALK rearrangement. Participants with tumors of unknown EGFR or ALK status will require testing only in never smokers

• All participants with brain metastases with protocol defined exceptions

• Previous malignant disease (other than NSCLC) within the last 5 years (except adequately treated non-melanoma skin cancers, carcinoma in situ of skin, bladder, cervix, colon/rectum, breast, or prostate) unless a complete remission without further recurrence was achieved at least 2 years prior to study entry and the participant was deemed to have been cured with no additional therapy required or anticipated to be required

• Active infection requiring systemic therapy

• Known history of human immunodeficiency virus or known acquired immunodeficiency syndrome

• Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV ribonucleic acid (RNA) if anti-HCV antibody screening test positive)

• Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent

• Interstitial parenchymal lung disease

• Pregnancy or lactation

• Known alcohol or drug abuse as determined by the Investigator

• History of uncontrolled intercurrent illness

• Clinically significant (that is active) cardiovascular disease

• Known history of inflammatory colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis

• Any psychiatric condition that would prohibit the understanding or rendering of informed consent or that would limit compliance with study requirements

• Prior/Concomitant Therapy as described in protocol

• Use of any investigational drug within 28 days before the start of study treatment

• Other protocol defined exclusion criteria could apply