Afatinib for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of a drug called afatinib in treating cancer with certain genetic changes. Afatinib targets a specific mutation in the EGFR gene, which can cause cancer cells to grow. The goal is to determine if afatinib can slow or stop this growth. Suitable candidates are patients whose cancer has specific EGFR mutations, excluding certain types like non-small cell lung cancer or glioblastoma. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
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 there any evidence suggesting that afatinib is likely to be safe for humans?
Research has shown that afatinib is usually well-tolerated by patients, but like any medication, it can have side effects. Earlier studies reported common side effects such as decreased appetite, nausea, and vomiting, affecting about 29%, 25%, and 23% of patients, respectively. Rare but serious skin reactions, including severe skin damage, have also been reported. Monitoring for any skin changes during treatment is important. Despite these risks, many patients have used afatinib, and the FDA has approved it for certain types of cancer, indicating that its safety is well understood. Always discuss any concerns or symptoms with your doctor during treatment.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for cancer, which often include chemotherapy and targeted therapies like EGFR inhibitors, afatinib is unique because it irreversibly blocks a range of signaling pathways involved in cancer cell growth. Most treatments target specific points, but afatinib goes a step further by inhibiting multiple members of the ErbB family of receptors, which are key players in tumor growth and survival. This broad-spectrum inhibition could potentially lead to more comprehensive and effective cancer control. Researchers are excited about afatinib because it offers a new way to tackle tumors that may not respond well to existing therapies.
What evidence suggests that afatinib might be an effective treatment for cancer?
Research has shown that afatinib, which participants in this trial will receive, may help treat certain cancers with specific genetic changes, especially mutations in the EGFR gene. Studies have found that afatinib works well as a first treatment for patients with lung adenocarcinoma, particularly those with rare EGFR mutations. In these patients, the cancer did not progress for an average of 13 months. Another study found that 59.5% of patients experienced either stabilization or improvement in their cancer. These results suggest that afatinib can help slow or stop cancer from spreading in patients with these specific genetic changes.46789
Who Is on the Research Team?
Scott N Gettinger
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Follow-up includes CT or MRI as clinically necessary.
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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:
- Non-small cell lung cancer
- Non-small cell lung cancer
- Non-small cell lung cancer
- Non-small cell lung cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Published Research Related to This Trial
Citations
Real-World Treatment Outcomes and Safety of Afatinib in ...
In this study, we observed the clinical outcomes of 2.1 months TTF and DCR of 59.5% with no new safety signals in patients with LSCC treated ...
Long term efficacy of first-line afatinib and the clinical utility ...
The effect of afatinib was greatest for the 16 patients with exon 19 deletion or L858R, with median PFS of 13.0 months (95% CI 5.9-39.3) and ...
Efficacy for Squamous mNSCLC | GILOTRIF® (afatinib) ...
Review GILOTRIF® clinical data for your metastatic squamous NSCLC patient progressing after platinumbased chemotherapy. See ISI and full PI.
Updated Analysis of the RESET Study
In this final report, the estimated median TOT was 15.0 months on afatinib and 11.9 months on osimertinib. The results from previous randomized controlled ...
The effectiveness of afatinib in patients with lung ...
Afatinib is an effective first-line treatment for patients with lung adenocarcinoma harboring complex EGFR mutations, especially those with uncommon mutation ...
Safety & Adverse Reactions | GILOTRIF® (afatinib) tablets
Other clinically important adverse reactions observed in patients treated with GILOTRIF included: decreased appetite (29%), nausea (25%), and vomiting (23%).
7.
pro.boehringer-ingelheim.com
pro.boehringer-ingelheim.com/us/products/gilotrif/important-safety-informationImportant Safety Information | GILOTRIF® (afatinib) tablets
Postmarketing cases of toxic epidermal necrolysis (TEN) and Stevens Johnson syndrome (SJS) have been reported in patients receiving GILOTRIF. Discontinue ...
GILOTRIF® (afatinib) tablets, for oral use - accessdata.fda.gov
The data in the Warnings and Precautions section reflect exposure to GILOTRIF for clinically significant adverse reactions in 4257 patients enrolled in LUX-Lung ...
Afatinib (oral route) - Side effects & dosage
Afatinib is used to treat metastatic (cancer that has already spread) non ... Safety and efficacy have not been established. Geriatric. Appropriate ...
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