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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Defined as the highest dose tested in which only 0 or 1 out of 6 evaluable patients experience a dose limiting toxicity, as graded by the National Cancer Institute (NCI) Common terminology Criteria for Adverse Events (CTCAE) version 5.0. The recommended phase II dose (RP2D) will be the MTD, pending review of other safety/tolerability considerations. The RP2D will be determined based upon the MTD in the dose escalation portion as well as other considerations such as toxicities at additional cours

Conditions Studied

Stage IV Lung Cancer AJCC v8 Metastatic Lung Non-Small Cell Carcinoma Recurrent Lung Non-Small Cell Carcinoma

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
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT02496663 still lists

NCT02496663 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, above the 97-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (42% higher).

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 lists 15 locations in 7 states (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.

Learn More About Clinical Trials

Similar trials for Stage IV Lung Cancer AJCC v8

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 NCT02496663's enrollment target sits among peer trials

138 13th of 81 higher than 69 of 81 other Stage IV Lung Cancer AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02496663, the US trial registry maintained by the National Library of Medicine. NCT02496663 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.