NCT02470065

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.

Trial Health

20
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_2

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

2.7 years

First QC Date

June 10, 2015

Last Update Submit

January 21, 2016

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLCEarly stagePhase IIRandomizedEGFR mutated

Outcome Measures

Primary Outcomes (1)

  • Decrease in cT-stage

    decrease in cT-stage descriptor measured according to RECIST 1.1

    8 weeks

Secondary Outcomes (2)

  • Response Rate

    8 weeks

  • Change in surgical treatment intent and technique

    8 weeks

Study Arms (2)

Neo adjuvant afatinib

EXPERIMENTAL

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: AfatinibProcedure: Immediate surgery

Immediate surgery

ACTIVE COMPARATOR

immediate surgery with curative intent (anatomical resection and systematic lymph node dissection).

Procedure: Immediate surgery

Interventions

AfatinibDRUG

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

Neo adjuvant afatinib
Immediate surgeryPROCEDURE

anatomical resection and systematic lymph node dissection

Immediate surgeryNeo adjuvant afatinib

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AmidesOrganic ChemicalsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Sanjay Popat, PhD

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 12, 2015

Study Start

January 1, 2016

Primary Completion

September 1, 2018

Study Completion

January 1, 2021

Last Updated

January 22, 2016

Record last verified: 2016-01