Necitumumab in the Neoadjuvant Setting With Gemcitabine in Surgically Resectable - 14X-US-I001
Status:
Terminated
Trial end date:
2019-09-26
Target enrollment:
Participant gender:
Summary
This will be a single-arm study to primarily evaluate the feasibility of administering
necitumumab added to gemcitabine and cisplatin as neoadjuvant treatment in treatment-naïve
patients with stage IB (tumor size >4cm), II or IIIA squamous NSCLC. Feasibility will be
assessed by the proportion of patients able to proceed to surgery after administering
necitumumab in the neoadjuvant setting. These patients would otherwise be offered standard
adjuvant chemotherapy (without necitumumab) for squamous cell lung cancer. Determination of
surgical resectability will be reviewed at a multidisciplinary thoracic tumor board, attended
by surgical oncology, medical oncology, radiation oncology, radiology, and pathology.