Study of Avelumab and Cetuximab Plus Gemcitabine and Cisplatin in Participants With NSCLC
Condition: Squamous Non-Small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Avelumab; Cetuximab; Gemcitabine; Cisplatin; Carboplatin
Intervention description: Participants received avelumab intravenous infusions at a dose of 800 milligram (mg) on Day 1 and Day 8 of each 3-week cycle for the first 4 cycles. Thereafter, administered every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities.; Participants received cetuximab intravenous infusions at a dose of 250 milligram per meter square (mg/m^2) body surface area on Day 1 and 500 mg/m^2 body surface area on Day 8 of first 4 cycles of concurrent chemotherapy. Thereafter, administered given at a dose of 500 mg/m^2 intravenous every 2 weeks in the Maintenance phase, until disease progression or unacceptable toxicities.; Participants received gemcitabine intravenous infusions at a dose of 1250 mg/m^2 body surface area on Day 1 and Day 8 in 3-week cycles up to a maximum of 4 cycles, until disease progression or unacceptable toxicities.; Participants received cisplatin intravenous infusions at a dose of 75 mg/m^2 body surface area on Day 1 of 3-week cycles up to a maximum of 4 cycles, until disease progression or unacceptable toxicities.; In case of cisplatin toxicities, participants were switched to carboplatin at a dose of target area under the serum concentration-time curve of 5 (AUC 5) on Day 1 for the remainder of cycles.
Intervention MeSH terms: Carboplatin; Gemcitabine; Cetuximab; Avelumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Avelumab; Cetuximab; Cisplatin; Gemcitabine; Non-Small Cell Lung Cancer

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 non-small-cell lung cancer (NSCLC).
    

Eligibility 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