NIPH Clinical Trials Search

Basic Information

Recruitment status	completed
Health condition(s) or Problem(s) studied	Stage IV Non-Small Cell Lung Cancer
Date of first enrollment	06/09/2016
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : necitumumab INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : necitumumab 800 mg on Days 1 and 8 of every 21 day cycle, administered as an IV infusion Generic name etc : pembrolizumab INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : pembrolizumab 200 mg on Day 1 of every 21 day cycle, administered as an IV infusion

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	-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
Exclude criteria