Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer.

• Status: Suspended
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Afatinib

Criteria

Inclusion Criteria:

Histological or cytological diagnosis of NSCLC;

• Patients considered operable and with resectable tumor with curative intent (anatomical resection and systematic lymph node dissection) based on evaluation by a thoracic multi-disciplinary team composed of at least a thoracic surgeon, oncologist and radiologist;

• Stage I-III (T1a-3, N0-1, M0 according to UICC version 7) NSCLC by local staging criteria potentially treatable by radical (curative) surgery. Patients with T1 tumor at baseline will be limited to 20%;

• Radiologically measurable disease according to RECIST criteria 1.1; assessed by chest and upper abdomen CT scan within 2 weeks (+1 week) prior to registration); brain CT scan or MRI according to local practice;

• No prior treatment for NSCLC is allowed;

• Adequate tissue in terms of quality and quantity for EGFR local testing.

Exclusion Criteria:

• no adequate bone marrow function within 2 weeks prior to randomization

• no adequate liver function. Patients with Gilbert's syndrome total bilirubin must be below 4 times institutional upper limit of normal; within 2 weeks prior to randomization

• no adequate renal function within 2 weeks prior to randomization

• known positivity to human immunodeficiency virus (HIV), hepatitis B or hepatitis C;

• known history of allergic reactions attributed to compounds of similar chemical or biological composition;

• history of a hematologic or primary solid tumor malignancy, unless no evidence of that disease for 5 years, except pT1-2 prostatic cancer Gleason score < 6, superficial bladder cancer, non melanoma skin cancer or carcinoma in situ of the cervix;