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NCT03225664 · ClinicalTrials.gov registry record · Phase 1

Trametinib and Pembrolizumab in Treating Patients With Recurrent Non-small Cell Lung Cancer That Is Metastatic, Unresectable, or Locally Advanced

A Phase 1 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.

Active
Registry status
Phase 1
Development phase
37
Enrollment target
2
Study locations

NCT03225664 is a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 37 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (62% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT03225664, a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
37 participants
Enrollment target
2
Study locations

Study Summary

This phase Ib/II trial studies the side effects and best dose of trametinib when given together with pembrolizumab and to see how well they work in treating patients with non-small cell lung cancer that has come back and spread to other places in the body, cannot be removed by surgery, or spread to nearby tissues or lymph nodes. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving trametinib and pembrolizumab may work better in treating patients with non-small cell lung cancer.

Conditions Studied

Stage IV Lung Cancer AJCC v8 Stage III Lung Cancer AJCC v8 Metastatic Lung Non-Small Cell Carcinoma Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Recurrent Lung Non-Small Cell Carcinoma Stage IIIA Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Unresectable Lung Non-Small Cell Carcinoma

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Trametinib
  • OTHER Pharmacokinetic Study

Study Locations (2)

Connecticut

  • Yale University - New Haven

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2018-02-03
Est. Completion 2027-12-31
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

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What the Registry Record Tells You About NCT03225664

The ClinicalTrials.gov registry entry for NCT03225664 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (62% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.

NCT03225664 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Connecticut, Texas.

Frequently Asked Questions

What is clinical trial NCT03225664 about?

NCT03225664 is a clinical study titled "Trametinib and Pembrolizumab in Treating Patients With Recurrent Non-small Cell Lung Cancer That Is Metastatic, Unresectable, or Locally Advanced". This phase Ib/II trial studies the side effects and best dose of trametinib when given together with pembrolizumab and to see how well they work in treating patients with non-small cell lung cancer that has come back and spread to other places in the body, cannot be removed by surgery, or spread to ...

What is the current status of trial NCT03225664?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2018-02-03. Estimated completion is 2027-12-31.

What conditions does trial NCT03225664 study?

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

What interventions are being tested in trial NCT03225664?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Trametinib (DRUG), Pharmacokinetic Study (OTHER).

Who is sponsoring clinical trial NCT03225664?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03225664 being conducted?

This trial has 2 study locations across Connecticut, Texas. 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.