NCT01746251

Brief Summary

This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied. It also means that the FDA has not yet approved afatinib for use in patients. In this research study the investigators are looking to see if taking afatinib after surgery works better when taken over a short period of time, compared to a long period of time.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
unknown

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

November 27, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

7.8 years

First QC Date

November 27, 2012

Last Update Submit

July 1, 2020

Conditions

Non Small Cell Lung Cancer

Keywords

EGFR mutationResected

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free survival

    The primary objective of this study is to demonstrate that prolonged adjuvant therapy with afatinib will improve recurrence free survival (RFS) compared to a concise adjuvant course in patients with resected stage I-III non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation.

    2 years

Secondary Outcomes (3)

  • Number of patients with adverse events

    2 years

  • Molecular genotype of recurrent cancers

    2 years

  • overall survival

    2 years

Study Arms (2)

Concise Afatinib

ACTIVE COMPARATOR

Afatinib oral daily dose for 3 months

Drug: Afatinib

Prolonged Afatinib

ACTIVE COMPARATOR

Afatinib oral daily dose for 2 years

Drug: Afatinib

Interventions

AfatinibDRUG
Concise AfatinibProlonged Afatinib

Eligibility Criteria

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

You may qualify if:

  • Pathologically confirmed diagnosis of non-small cell lung cancer with EGFR mutation
  • Complete surgical resection, pathologic stage IA-B, IIA-B, IIIA-B by AJCC 7th Edition staging criteria
  • Surgical resection with curative intent was at least 6 months prior to enrollment
  • At least 3 weeks have passed since completion of adjuvant chemotherapy or radiotherapy

You may not qualify if:

  • Pregnant or breastfeeding
  • History of allergic reactions attributed to compounds of similar chemical composition to afatinib
  • Prior exposure to EGFR tyrosine kinase inhibitor
  • Evidence of clinically active interstitial lung disease
  • Radiographic evidence of recurrent NSCLC prior to afatinib treatment
  • Receipt of any experimental treatment within 30 days of start of treatment with afatinib until the end of treatment visit
  • Use of potent P-gp inhibitors and potent P-gp inducers must be avoided during treatment with afatinib
  • Individuals with a history of a different malignancy (except: synchronous or metachronous primary non-small cell lung cancers of lower stage than the cancer for which adjuvant treatment is currently being prescribed; disease free for at least 3 years; cervical cancer in situ; basal or squamous cell carcinoma of the skin)
  • HIV positive on combination antiretroviral therapy
  • Uncontrolled intercurrent illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Stanford University

Palo Alto, California, 94304, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan Kettering

New York, New York, 10065, United States

Location

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

  • Lecia Sequist, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 27, 2012

First Posted

December 10, 2012

Study Start

January 1, 2013

Primary Completion

November 1, 2020

Study Completion

November 1, 2021

Last Updated

July 7, 2020

Record last verified: 2020-07

Locations

US(4)