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ACTIVE NOT RECRUITING 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

NCT02496663 · View on ClinicalTrials.gov ↗

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)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02496663

The ClinicalTrials.gov registry entry for NCT02496663 describes a study currently listed as active not recruiting. It is categorized as Phase 1, 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 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT02496663 reports 15 study locations spanning 7 distinct geographic areas — top geographies include Massachusetts, California, Georgia. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02496663?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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