Study on Afatinib for Cancers with HER2 Genetic Changes (MATCH-Subprotocol B)

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT04439136

Provider View

This clinical trial is testing afatinib, a drug that may help stop the growth of cancer cells with specific HER2 genetic changes. The study aims to see if afatinib can shrink these cancers or stop them from growing.

Patient Parameters

Program Overview

This phase II study is exploring the effects of afatinib in patients whose cancers have specific genetic changes known as HER2 mutations. Afatinib works by blocking the HER2 receptor, which is a protein that may be necessary for cancer cell growth. Researchers want to find out if afatinib can help reduce the size of these cancers or prevent them from growing further.

Description

The main goal of this study is to see how many patients with advanced cancers, lymphomas, or multiple myeloma respond to afatinib treatment. Researchers will also look at how many patients are alive and have not experienced cancer progression after six months of treatment. They will study the time it takes for the disease to progress or for patients to pass away. Additionally, the study will explore other potential markers that might predict how well the treatment works or why it might not work, using various tests on genes, RNA, proteins, and imaging.

Patients in the study will take afatinib by mouth once a day for 28 days. This cycle will repeat every 28 days as long as the cancer does not progress and the patient does not experience unacceptable side effects. After finishing the treatment, patients will have follow-up visits every three months for up to two years, and then every six months in the third year.

Eligibility Criteria

Inclusion Criteria

  • Must meet the eligibility criteria of the Master MATCH Protocol before joining this study.
  • The cancer must have a specific HER2 mutation, confirmed by the MATCH Master Protocol.
    • Any in-frame insertions in exon 20 are considered activating mutations.
  • Must have a recent electrocardiogram (ECG) showing no significant heart rhythm or structure issues.
  • If there is known heart dysfunction, a recent echocardiogram or nuclear study must show normal heart function.
    • If no heart dysfunction is known, this test is not required.
  • Must have mild or no diarrhea at the start of the study.
  • Must have normal or mildly impaired kidney function:
    • Creatinine levels must be within 1.5 times the normal limit, or
    • Creatinine clearance must be at least 60 mL/min/1.73 m² if creatinine levels are high.

Exclusion Criteria

  • Cannot have an allergy to afatinib or similar drugs.
  • Cannot have a history of interstitial lung disease.
  • Cannot have been treated with certain other drugs that target HER2, including:
    • Neratinib
    • AC-480 (BMS-599626)
    • AST 1306
    • Canertinib (CI 1033)
    • CUDC-101
    • Lapatinib
    • TAK285
    • Afatinib
    • AEE 788
    • AZD8931
    • CP-724714
    • Dacomitinib
    • Pelitinib
  • Patients with non-small cell lung cancer are not eligible.

Locations

FACILITYZIPCITYSTATE
ECOG-ACRIN Cancer Research Group19103PhiladelphiaPennsylvania

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