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NCT02438722 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Stage IV Non-small Cell Lung Cancer and Recurrent Non-Small Cell Lung Carcinoma, sponsored by SWOG Cancer Research Network.
- Active
- Registry status
- Phase 2
- Development phase
- 174
- Enrollment target
- 20
- Study locations
NCT02438722: Active Phase 2 study of Stage IV Non-small Cell Lung Cancer and Recurrent Non-Small Cell Lung Carcinoma, sponsored by SWOG Cancer Research Network.
NCT02438722 is a Phase 2 study of Stage IV Non-small Cell Lung Cancer and Recurrent Non-Small Cell Lung Carcinoma that is active but no longer recruiting, run by SWOG Cancer Research Network. The registered enrollment target is 174 participants, below the 682-participant average among 23 other Stage IV Non-small Cell Lung Cancer trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02438722, a Phase 2 study of Stage IV Non-small Cell Lung Cancer and Recurrent Non-Small Cell Lung Carcinoma, is active but no longer recruiting, sponsored by SWOG Cancer Research Network.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 174 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Percentage of participants still alive 2 years post registration. KM estimate at 2 years is presented, Overall Survival assessed for a total of 3 years in order to calculate value.
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 |
What the registry record for NCT02438722 still lists
NCT02438722 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, below the 682-participant average among 23 other Stage IV Non-small Cell Lung Cancer trials with a reported enrollment target (74% lower).
The record links to 2 conditions, with Stage IV Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Cetuximab is the first listed.
NCT02438722 names 20 study sites across 2 states, led by California, Arkansas.
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: Stage IV Non-small Cell Lung Cancer, Recurrent Non-Small Cell Lung Carcinoma.
What interventions are being tested in trial NCT02438722?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Afatinib Dimaleate (DRUG).
Who is sponsoring clinical trial NCT02438722?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Stage IV Non-small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02438722's enrollment target sits among peer trials
174 5th of 23 higher than 19 of 23 other Stage IV Non-small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Non-small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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