NCT02470065

Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer.

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

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Afatinib	once daily afatinib at a dose of 40 mg for 8 weeks
PROCEDURE	Immediate surgery	anatomical resection and systematic lymph node dissection

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-09-01
• Completion: 2021-01-01
• First posted: 2015-06-12
• Last updated: 2016-01-22