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

A Phase IIa, Single-arm, Multicenter Study to Investigate the Clinical Activity and Safety of Avelumab in Combination With Cetuximab Plus Gemcitabine and Cisplatin in Participants With Advanced Squamous NSCLC

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 non-small-cell lung cancer (NSCLC).

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