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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 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.

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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.

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

FieldValue
Enrollment Target 174 participants
Start Date 2015-05-07
Est. Completion 2026-12-31
Phase Phase 2

Sponsor

SWOG Cancer Research Network

270 total trials

What the Registry Record Tells You About NCT02438722

The ClinicalTrials.gov registry entry for NCT02438722 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 682-participant average among 23 other Stage IV Non-small Cell Lung Cancer trials with a reported enrollment target (74% lower). The listed sponsor is SWOG Cancer Research Network, which has 270 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.