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NCT02496663 · ClinicalTrials.gov registry record · Phase 1

Osimertinib and Necitumumab in Treating Patients With EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor

A Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
138
Enrollment target
15
Study locations

NCT02496663 is a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 138 participants, above the 97-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (42% higher). The trial reports 15 study locations across 7 states.

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The verdict

NCT02496663, a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
138 participants
Enrollment target
15
Study locations

Study Summary

This phase I trial studies the safety, side effects and best dose of necitumumab when given together with osimertinib in treating patients with EGFR-mutant non-small cell lung cancer that is stage IV or has come back after a period of improvement (recurrent) and who have progressed on a previous EGFR tyrosine kinase inhibitor. Immunotherapy with monoclonal antibodies, such as necitumumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving necitumumab with osimertinib may be safe, tolerable in treating patients with EGFR-mutant non-small cell lung cancer.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Echocardiography Test
  • PROCEDURE Multigated Acquisition Scan
  • PROCEDURE Magnetic Resonance Elastography

Study Locations (15)

Massachusetts

  • Massachusetts General Hospital Cancer Center - Boston
  • Brigham and Women's Hospital - Boston
  • Beth Israel Deaconess Medical Center - Boston
  • Dana-Farber Cancer Institute - Boston

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • Stanford Cancer Institute Palo Alto - Palo Alto
  • University of California Davis Comprehensive Cancer Center - Sacramento

Georgia

  • Emory University Hospital Midtown - Atlanta
  • Emory University Hospital/Winship Cancer Institute - Atlanta
  • Emory Saint Joseph's Hospital - Atlanta

North Carolina

  • Duke Cancer Center Cary - Cary
  • Duke University Medical Center - Durham

Colorado

  • UCHealth University of Colorado Hospital - Aurora

District of Columbia

  • MedStar Georgetown University Hospital - Washington D.C.

Pennsylvania

  • University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh

Trial Details

FieldValue
Enrollment Target 138 participants
Start Date 2016-05-11
Est. Completion 2027-06-30
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT02496663

The ClinicalTrials.gov registry entry for NCT02496663 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 97-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (42% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT02496663 reports 15 study locations spanning 7 distinct geographic areas - top geographies include Massachusetts, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT02496663 about?

NCT02496663 is a clinical study titled "Osimertinib and Necitumumab in Treating Patients With EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor". This phase I trial studies the safety, side effects and best dose of necitumumab when given together with osimertinib in treating patients with EGFR-mutant non-small cell lung cancer that is stage IV or has come back after a period of improvement (recurrent) and who have progressed on a previous EGF...

What is the current status of trial NCT02496663?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 138 participants. The study started on 2016-05-11. Estimated completion is 2027-06-30.

What conditions does trial NCT02496663 study?

This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma.

What interventions are being tested in trial NCT02496663?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Echocardiography Test (PROCEDURE), Multigated Acquisition Scan (PROCEDURE), Magnetic Resonance Elastography (PROCEDURE).

Who is sponsoring clinical trial NCT02496663?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02496663 being conducted?

This trial has 15 study locations across California, Colorado, District of Columbia, Georgia, Massachusetts. 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.