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S1403, Afatinib Dimaleate With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage IV or Recurrent, EGFR Mutation Positive Non-small Cell Lung Cancer
NCT02438722 · View on ClinicalTrials.gov ↗
Study Summary
This randomized phase II/III trial studies how well afatinib dimaleate with cetuximab works and compares it with afatinib dimaleate alone in treating patients with newly diagnosed stage IV or recurrent (has come back), epidermal growth factor receptor (EGFR) mutation positive non-small cell lung cancer. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. It is not yet known whether afatinib dimaleate is more effective when given alone or with cetuximab in treating patients with non-small cell lung cancer.
Conditions Studied
Interventions
- BIOLOGICAL Cetuximab
- OTHER Laboratory Biomarker Analysis
- DRUG Afatinib Dimaleate
Study Locations (20)
California
- Kaiser Permanente-Anaheim — Anaheim
- PCR Oncology — Arroyo Grande
- Sutter Auburn Faith Hospital — Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn
- AIS Cancer Center at San Joaquin Community Hospital — Bakersfield
- Kaiser Permanente-Baldwin Park — Baldwin Park
- Kaiser Permanente-Bellflower — Bellflower
- Alta Bates Summit Medical Center-Herrick Campus — Berkeley
- Mills-Peninsula Medical Center — Burlingame
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park
- Eden Hospital Medical Center — Castro Valley
- Sutter Davis Hospital — Davis
- Kaiser Permanente-Fontana — Fontana
- Palo Alto Medical Foundation-Fremont — Fremont
- Kaiser Permanente - Harbor City — Harbor City
- Kaiser Permanente-Irvine — Irvine
- UC San Diego Moores Cancer Center — La Jolla
Arkansas
- Mercy Hospital Fort Smith — Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs — Hot Springs
- Fowler Family Center for Cancer Care — Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2015-05-07 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02438722
The ClinicalTrials.gov registry entry for NCT02438722 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 212 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Recurrent Non-Small Cell Lung Carcinoma appearing as the primary indexed condition, and to 3 interventions — of which Cetuximab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02438722 reports 20 study locations spanning 2 distinct geographic areas — top geographies include California, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02438722 about?
NCT02438722 is a clinical study titled "S1403, Afatinib Dimaleate With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage IV or Recurrent, EGFR Mutation Positive Non-small Cell Lung Cancer". This randomized phase II/III trial studies how well afatinib dimaleate with cetuximab works and compares it with afatinib dimaleate alone in treating patients with newly diagnosed stage IV or recurrent (has come back), epidermal growth factor receptor (EGFR) mutation positive non-small cell lung can...
What is the current status of trial NCT02438722?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 174 participants. The study started on 2015-05-07. Estimated completion is 2026-12-31.
What conditions does trial NCT02438722 study?
This clinical trial studies the following conditions: Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02438722?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Afatinib Dimaleate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02438722?
This trial is sponsored by SWOG Cancer Research Network, which has 212 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02438722 being conducted?
This trial has 20 study locations across Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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