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Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer. (REMNANT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02470065
Recruitment Status : Suspended (Study never started)
First Posted : June 12, 2015
Last Update Posted : January 22, 2016
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Afatinib Procedure: Immediate surgery Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Resectable EGFR Mutant NSCLC With (or Without) Afatinib as Neoadjuvant Treatment; REMNANT an Exploratory Study of the EORTC Lung Cancer Group
Study Start Date : January 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neo adjuvant afatinib
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).
Drug: Afatinib
once daily afatinib at a dose of 40 mg for 8 weeks

Procedure: Immediate surgery
anatomical resection and systematic lymph node dissection

Active Comparator: Immediate surgery
immediate surgery with curative intent (anatomical resection and systematic lymph node dissection).
Procedure: Immediate surgery
anatomical resection and systematic lymph node dissection




Primary Outcome Measures :
  1. Decrease in cT-stage [ Time Frame: 8 weeks ]
    decrease in cT-stage descriptor measured according to RECIST 1.1


Secondary Outcome Measures :
  1. Response Rate [ Time Frame: 8 weeks ]
    proportion of patients whose response is either complete response (CR) or partial response (PR) using RECIST 1.1;

  2. Change in surgical treatment intent and technique [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470065


Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
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Principal Investigator: Sanjay Popat, PhD Royal Marsden NHS Foundation Trust
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT02470065    
Other Study ID Numbers: EORTC-08115
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: January 2016
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
NSCLC
Early stage
Phase II
Randomized
EGFR mutated
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Afatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action