Afatinib +/− Cetuximab for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments for non-small cell lung cancer that has spread or recurred and is positive for certain EGFR mutations (cell changes that can lead to cancer). It compares the effectiveness of afatinib dimaleate alone to afatinib dimaleate combined with cetuximab, a monoclonal antibody targeting cancer cells. The goal is to determine if adding cetuximab improves treatment outcomes. The trial seeks participants with stage IV or recurrent non-small cell lung cancer with specific genetic mutations who have not received prior treatment for advanced disease. 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 does not specify if you need to stop taking your current medications. However, you must not have received any prior systemic anticancer therapy for advanced or metastatic disease, and you cannot be planning to receive any other investigational agents during the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that afatinib dimaleate is generally safe for people with non-small cell lung cancer. One study found serious side effects in about 7.3% of patients, indicating most tolerated it well. No new safety issues emerged when used in everyday settings.
When combined with cetuximab, some studies indicate afatinib causes more side effects than when used alone. However, this combination still effectively fights tumors and might help prevent cancer from becoming resistant to treatment, despite the increased risk of side effects.
Both treatments are under study, but afatinib already has FDA approval for other lung cancer uses, indicating a known safety record. As with any treatment, discussing potential risks and benefits with a healthcare provider is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about afatinib dimaleate, with or without cetuximab, for treating non-small cell lung cancer because it offers a unique approach compared to the standard chemotherapy and immunotherapy options. Afatinib dimaleate works as a tyrosine kinase inhibitor, specifically targeting the epidermal growth factor receptor (EGFR), which plays a crucial role in the growth and spread of cancer cells. This targeted action can lead to more precise treatment with potentially fewer side effects. In the combination arm, cetuximab adds an extra layer by also targeting EGFR but through a different mechanism, which might enhance the overall effectiveness against resistant cancer cells.
What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?
Research shows that afatinib, which participants in this trial may receive, effectively treats non-small cell lung cancer (NSCLC) with specific genetic changes called EGFR mutations. Studies indicate that patients taking afatinib live for more than four years on average and have a high response rate of 77.2%. In this trial, some participants will receive afatinib alone, while others will receive a combination of afatinib and cetuximab. Adding cetuximab, a medicine that targets cancer cells, might enhance afatinib's effectiveness. Early research suggests that using afatinib and cetuximab together can help prevent or slow the cancer's resistance to treatment. While both treatments show promise individually, researchers continue to study their combined effectiveness.16789
Who Is on the Research Team?
Sarah Goldberg
Principal Investigator
SWOG Cancer Research Network
Are You a Good Fit for This Trial?
This trial is for adults with stage IV or recurrent non-small cell lung cancer (NSCLC) that tests positive for EGFR mutations. Participants must be able to take oral medication, have not had major surgery recently, and cannot have active hepatitis B/C or HIV. They should not have significant heart issues, gastrointestinal disorders causing diarrhea, or a history of allergic reactions to similar drugs. Women who are pregnant or nursing are excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive afatinib dimaleate orally once daily and cetuximab intravenously on specified days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
What Are the Treatments Tested in This Trial?
Interventions
- Afatinib Dimaleate
- Cetuximab
Trial Overview
The study compares the effectiveness of afatinib dimaleate alone versus combined with cetuximab in treating NSCLC with EGFR mutations. Afatinib blocks enzymes needed for tumor growth while cetuximab targets certain cells to inhibit tumor expansion.
How Is the Trial Designed?
Patients receive afatinib dimaleate PO QD on days 1-28 and cetuximab IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive afatinib dimaleate as in Arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Find a Clinic Near You
Who Is Running the Clinical Trial?
SWOG Cancer Research Network
Lead Sponsor
Southwest Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Published Research Related to This Trial
Citations
Afatinib in the first-line treatment of patients with non-small cell ...
The clinical activity of afatinib has been also confirmed in real-life studies. A recent retrospective Taiwanese cohort study reported a 77.2% ORR and a median ...
Real-world Afatinib Outcomes in Advanced Non–small Cell ...
The median overall survival (OS) was 61.8 months for patients with T790M mutation undergoing later-line osimertinib compared with 30.1 months for patients ...
Long term efficacy of first-line afatinib and the clinical utility ...
Afatinib is a viable treatment option for tissue or ctDNA-detected EGFR mutant NSCLC comorbid patients, with a proportion achieving long-term clinical benefit.
Real-world first-line afatinib for advanced EGFR mutation ...
Conclusions: Afatinib was effective in Korean patients with EGFR mutation-positive NSCLC with median OS over 4 years. The presence of baseline ...
Afatinib Effective in NSCLC Patients With Rare EGFR ...
Median overall survival (OS) was 19.4 months (95% CI: 16.4–26.9) in group one, 14.9 months (8.1–24.9) in group two, and 9.2 months (4.1–14.2) in ...
Pembrolizumab and Afatinib in Patients With Non-small ...
Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and afatinib dimaleate ...
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 ...
Assessing Patient Risk, Benefit, and Outcomes in Drug ...
We investigated published afatinib clinical trials to assess risk and benefit profiles for the drug in its approved indication of non–small-cell lung cancer as ...
Efficacy and Safety of Afatinib for EGFR-mutant Non-small ...
Overall toxicity profiles of the three drugs were comparable, though more grade 3 or 4 toxicities were detected in afatinib (7.3%) compared with ...
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