An Open Label Multicenter Phase 1b Study with Expansion Cohorts to Evaluate Safety and Efficacy of the Combination of Necitumumab with Pembrolizumab in Patients with Stage IV Non Small Cell Lung Cancer and Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (I4X-MC-JFCQ)
- Conditions
- Stage IV Non-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080223316
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- Not specified
NSCLC Stage IV (squamous and nonsquamous)
-The patient must have progressed after 1 platinum-based chemotherapy regimen. 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 patients 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 tumor tissue available for biomarker analyses.
-The participant has adequate organ function.
-Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method