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Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer.

NCT02470065 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2016-01-22

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Afatinib

once daily afatinib at a dose of 40 mg for 8 weeks

PROCEDURE

Immediate surgery

anatomical resection and systematic lymph node dissection

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Sanjay Popat, PhD · Royal Marsden NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-09-30
Completion
2021-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02470065 on ClinicalTrials.gov