Spots Global Cancer Trial Database for Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer.

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Trial Identification

Brief Title: Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer.

Official Title: Resectable EGFR Mutant NSCLC With (or Without) Afatinib as Neoadjuvant Treatment; REMNANT an Exploratory Study of the EORTC Lung Cancer Group

Study ID: NCT02470065

Conditions

Non Small Cell Lung Cancer

Interventions

Afatinib

Immediate surgery

Study Description

Brief Summary: This is a multicenter, randomized, 1:1, non-comparative phase II trial. Patients with early stage NSCLC will be randomized between ARM A: neoadjuvant afatinib followed by surgery and ARM B: immediate surgery with curative intent.

Detailed Description: This is a multicenter, prospective, open-label, randomized, non-comparative, two-arm phase II trial aiming to evaluate afatinib treatment in pre-operative setting in patients with EGFR mutated NSCLC. After signing of the informed consent, patients will be registered and screened for eligibility and upon confirmation of all eligibility criteria, patients will be randomized 1:1 to: * Arm A: once daily afatinib at a dose of 40 mg for 8 weeks followed by surgery with curative intent (anatomical resection and systematic lymph node dissection). * Arm B: immediate surgery with curative intent (anatomical resection and systematic lymph node dissection). Response evaluation in the pre-operative arm will be performed through CT scans at baseline, 4 and 8 weeks. The first 5 patients enrolled in arm A will be part of a safety run-in to check that afatinib treatment doesn't delay surgery.