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NCT03054038 · ClinicalTrials.gov registry record · Phase 1

Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer

A Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.

Terminated
Registry status
Phase 1
Development phase
22
Enrollment target

NCT03054038: Clinical Trial Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.

NCT03054038 is a Phase 1 study that was terminated before completion, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03054038, a Phase 1 study, was terminated before completion, sponsored by Vanderbilt-Ingram Cancer Center.

TERMINATED
Registry status
Phase 1
Development phase
22 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best dose of afatinib and necitumumab and to see how well they work in treating patients with EGFR mutation positive non-small cell lung cancer that has spread to other places in the body. Afatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as necitumumab, may interfere with the ability of tumor cells to grow and spread. Giving afatinib and necitumumab may work better in treating patients with EGFR mutation positive non-small cell lung cancer.

Primary Outcome

Highest dosage at which 0 or 1/6 patients

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Afatinib
  • BIOLOGICAL Necitumumab

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2017-07-20
Est. Completion 2022-03-23
Phase Phase 1
Vanderbilt-Ingram Cancer Center

189 total trials

Why NCT03054038 stopped before completion

NCT03054038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).

The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT03054038 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03054038 about?

NCT03054038 is a clinical study titled "Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer". This phase I trial studies the side effects and best dose of afatinib and necitumumab and to see how well they work in treating patients with EGFR mutation positive non-small cell lung cancer that has spread to other places in the body. Afatinib may stop the growth of tumor cells by blocking some of...

What is the current status of trial NCT03054038?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2017-07-20. Estimated completion is 2022-03-23.

What interventions are being tested in trial NCT03054038?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Afatinib (DRUG), Necitumumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT03054038?

This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03054038's enrollment target sits among peer trials

22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT03054038, the US trial registry maintained by the National Library of Medicine. NCT03054038 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.