A Study of the Combination of Necitumumab (LY3012211) and Pembrolizumab (MK3475) in Participants With NSCLC
Condition: Stage IV Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Necitumumab; Pembrolizumab
Intervention description: Administered IV; Administered IV
Intervention MeSH terms: Pembrolizumab; Necitumumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the safety and efficacy of the combination of
      necitumumab with pembrolizumab in participants with stage IV non-small cell lung cancer
      (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant has Stage IV NSCLC.

               -  Part A: NSCLC Stage IV (any type)

               -  Part B: NSCLC Stage IV (squamous and nonsquamous)

               -  Part C: NSCLC Stage IV in Japanese participants (squamous and nonsquamous)

          -  The participant must have progressed after 1 platinum-based chemotherapy regimen for
             Stage IV NSCLC. Prior therapy with VEGF/VEGFR targeting agents is permitted. Prior
             neoadjuvant/adjuvant therapy is permitted. Prior treatment with EGFR-TKI and ALK
             inhibitors is mandatory in participants with NSCLC whose tumor has EGFR-activating
             mutations or ALK translocations, respectively.

          -  Measurable disease at the time of study entry as defined by Response Evaluation
             Criteria In Solid Tumors Version 1.1 (RECIST 1.1).

          -  The participant has evaluable tumor tissue available for biomarker analyses.

          -  The participant has adequate organ function.

          -  Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1.

        Exclusion Criteria:

          -  The participant is currently enrolled in a clinical trial involving an investigational
             product or non-approved use of a drug or device.

          -  Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 monoclonal antibody.

          -  Have a serious concomitant systemic disorder or significant cardiac disease.

          -  The participant has undergone major surgery or received anti-cancer monoclonal
             antibody therapy in the 30-days prior to study enrollment.

          -  The participant has undergone chest irradiation within 2 weeks prior to receiving
             study treatment.

          -  The participant has brain metastases that are symptomatic.

          -  The participant has a history of arterial thromboembolism event (ATE) or venous
             thromboembolism event (VTE) within 3 months prior to study enrollment. Participants
             with history of VTE beyond 3 months prior to study enrollment can be enrolled if they
             are appropriately treated with low molecular weight heparin.

          -  The participant has a known allergy / history of hypersensitivity reaction to any of
             the treatment components, including any ingredient used in the formulation of
             necitumumab or pembrolizumab, or any other contraindication to one of the administered
             treatments.

          -  The participant has a concurrent active malignancy. Previous history of malignancy is
             permitted, provided that the participant has been free of disease for ≥3 years, with
             the exception of adequately treated basal or squamous cell carcinoma of the skin,
             preinvasive carcinoma of the cervix, or any cancers that in the judgment of the
             investigator and sponsor may not affect the interpretation of results (for example,
             prostate, bladder).

          -  History of interstitial lung disease, pneumonitis, autoimmune disease or syndrome that
             requires steroids or immunosuppressive agents.

          -  The participant has active infection requiring systemic therapy, including active
             tuberculosis or known history of infection with the human immunodeficiency virus (HIV
             1/2 antibodies), or hepatitis B (e.g., HBsAg reactive) and/or C virus (e.g., HCV RNA
             [qualitative] is detected).

          -  The participant has an active autoimmune disease or a documented history of autoimmune
             disease, or a syndrome that requires systemic steroids or immunosuppressive agents.

          -  The participant has received a live vaccine within 30 days prior to the first dose of
             trial treatment.