Apply to Trial

Compensation: Varies

Number of Visits: 5

Duration: Up to 3 years

19 Participants Needed

Afatinib for Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: EGFR inhibitors

Disqualifiers: Lung cancer, Glioblastoma, Interstitial lung, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This phase II MATCH treatment trial tests how well afatinib works in treating patients with cancer that has certain genetic changes. Afatinib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the EGFR gene. It works by blocking the action of mutated EGFR that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you must not have had prior treatment with an EGFR tyrosine kinase inhibitor (a type of cancer medication).

Is Afatinib safe for humans?

Afatinib, also known as Gilotrif, is generally safe for humans but can cause side effects like diarrhea, skin rash, and mouth sores. These side effects are usually manageable with dose adjustments and proper care.¹ ² ³ ⁴ ⁵

How is the drug Afatinib unique in treating cancer?

Afatinib is unique because it is an oral medication that irreversibly blocks the ErbB family of proteins, which are involved in cancer cell growth, making it particularly effective for non-small cell lung cancer with specific EGFR mutations. Unlike some other treatments, it has shown to prolong progression-free survival and improve outcomes in certain patient subgroups.² ⁵ ⁶ ⁷ ⁸

Research Team

Scott N Gettinger

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for cancer patients with specific genetic changes in the EGFR gene. It's open to those with various cancers like lymphoma, solid tumors, and multiple myeloma who meet certain health standards.

Inclusion Criteria

My diarrhea is mild or nonexistent.

Pre-treatment LVEF determination in patients without known left ventricular dysfunction is NOT required

Patients must not have known hypersensitivity to afatinib or similar compounds

See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Treatment

Participants receive afatinib orally once daily on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Up to 3 years

Every 2 cycles for the first 26 cycles, then every 3 cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment. Follow-up includes CT or MRI as clinically necessary.

3 years

Every 3 months for 2 years, then every 6 months for 1 year

Treatment Details

Interventions

Afatinib

Trial Overview The study is testing afatinib, a kinase inhibitor medication that targets mutated EGFR genes to halt or slow cancer cell growth. The trial involves tests like MRI, echocardiography, biopsies, biospecimen collection, radionuclide imaging, and CT scans.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (afatinib)Experimental Treatment7 Interventions

Patients receive afatinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients may also undergo ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.

Afatinib is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Gilotrif for:

Non-small cell lung cancer

Approved in European Union as Giotrif for:

Non-small cell lung cancer

Approved in Canada as Gilotrif for:

Non-small cell lung cancer

Approved in Japan as Giotrif for:

Non-small cell lung cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Findings from Research

Afatinib is an effective oral treatment for adults with advanced non-small cell lung cancer (NSCLC) who have specific activating EGFR mutations, showing significantly prolonged progression-free survival compared to standard chemotherapy regimens in two phase III trials.

The drug has a manageable safety profile, with common side effects like diarrhea and rash being effectively controlled through dose adjustments, making it a valuable option for treatment-naïve patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Afatinib: a review of its use in the treatment of advanced non-small cell lung cancer.Keating, GM.[2022]

Afatinib is an effective first-line treatment for advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations, showing improved progression-free survival (PFS) compared to gefitinib and cisplatin-based chemotherapy, although it did not extend overall survival (OS) for all patients.

As a second-line treatment for advanced squamous NSCLC, afatinib significantly prolonged both PFS and OS compared to erlotinib, demonstrating its efficacy regardless of EGFR mutation status, and it has a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Afatinib in advanced NSCLC: a profile of its use.Deeks, ED., Keating, GM.[2020]

Afatinib is an irreversible inhibitor of the ErbB family of tyrosine kinases, specifically approved for treating advanced non-small-cell lung cancer in adults with EGFR mutations.

Ongoing research is exploring the efficacy of afatinib in treating other types of cancers, such as head and neck squamous cell carcinoma (HNSCC) and breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Afatinib.Wecker, H., Waller, CF.[2018]