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UnknownPhase 2NCT01746251
Official study title

Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAfatinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 7, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Unknown

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Massachusetts General Hospital

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Massachusetts General Hospital
Interventions being studied
Drug: Afatinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Early-stage or resectable→
Biomarkers
EGFR→
Treatment approach
Surgery→
Study topics
After surgery (adjuvant)→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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
Reasons someone may not be able to joinExclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Stanford UniversityPalo Alto, California
  • Beth Israel Deaconess Medical CenterBoston, Massachusetts
  • Massachusetts General HospitalBoston, Massachusetts
  • Memorial Sloan KetteringNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 7, 2020. Always confirm current availability with the study team.

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