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Compensation: Varies

Number of Visits: 2

Duration: Up to 3 years

40 Participants Needed

Afatinib for Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Tyrosine kinase inhibitors

Disqualifiers: Hypersensitivity to afatinib, Interstitial lung disease, Non-small cell lung cancer, 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 identifies the effects of afatinib in patients whose cancer has genetic changes called HER2 mutations. Afatinib may stop the growth of cancer cells by blocking the HER2 receptor, a protein that may be needed for cell growth. Researchers hope to learn if afatinib will shrink this type of cancer or stop its growth.

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 cannot have taken certain medications like afatinib or other similar drugs before joining the trial.

Is Afatinib generally safe for humans?

Afatinib, also known as Gilotrif, is generally considered safe for humans, but it 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 includes the epidermal growth factor receptor (EGFR), and is particularly effective for non-small cell lung cancer (NSCLC) with specific EGFR mutations. It offers a significant advantage in prolonging progression-free survival compared to some other treatments, especially in patients with certain genetic profiles.² ⁵ ⁶ ⁷ ⁸

Research Team

Philippe L Bedard

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for cancer patients with specific HER2 genetic changes. They must have normal heart function, controlled diarrhea, and adequate kidney function. People with hypersensitivity to afatinib, lung disease history, or previous treatment with certain tyrosine kinase inhibitors are excluded.

Inclusion Criteria

I currently have mild or no diarrhea.

My recent ECG showed no significant heart issues.

My tumor has an activating HER2 mutation.

See 5 more

Exclusion Criteria

I have not taken any medication known to target HER2.

Patients must not have known hypersensitivity to afatinib or compounds of similar chemical or biologic composition

I have never had interstitial lung disease.

See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive afatinib dimaleate orally once daily on days 1-28. 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 thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 3 months if less than 2 years from study entry, and then every 6 months for year 3.

Up to 3 years

Treatment Details

Interventions

Afatinib

Trial Overview The trial tests Afatinib Dimaleate's effectiveness on cancers with HER2 mutations. It aims to see if this drug can shrink the tumors or halt their growth by blocking a protein essential for cancer cell development.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (afatinib dimaleate)Experimental Treatment1 Intervention

Patients receive afatinib dimaleate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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]