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NCT05435846 · ClinicalTrials.gov registry record · Phase 1

Capmatinib Plus Trametinib for the Treatment of Metastatic Non-small Cell Lung Cancer With MET Exon 14 Skipping Mutation

A Phase 1 study, sponsored by Collin Blakely.

Terminated
Registry status
Phase 1
Development phase
3
Enrollment target

NCT05435846: Clinical Trial Phase 1 study, sponsored by Collin Blakely.

NCT05435846 is a Phase 1 study that was terminated before completion, run by Collin Blakely. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05435846, a Phase 1 study, was terminated before completion, sponsored by Collin Blakely.

TERMINATED
Registry status
Phase 1
Development phase
3 participants
Enrollment target

Study Summary

This phase I/Ib trial studies the side effects and best doses of capmatinib plus trametinib when given together for the treatment of patients with MET exon 14 skipping mutation non-small cell lung cancer that has spread to other places in the body (metastatic). Capmatinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Trametinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. Capmatinib and trametinib are "targeted therapies." These targeted therapies work by detecting and targeting a mutation in the MET gene. Giving Capmatinib and trametinib may kill more tumor cells in patients with metastatic non-small cell lung cancer.

Primary Outcome

Proportion of participants who experience a DLT for capmatinib in combination with trametinib in Phase I. A dose limiting toxicity (DLT) will be defined as any adverse event that are considered by the investigator to be at least possibly related to capmatinib or trametinib and are observed during the first 28 days of treatment (Cycle 1).

Interventions

  • DRUG Capmatinib
  • DRUG Trametinib

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2022-08-10
Est. Completion 2024-05-31
Phase Phase 1
Collin Blakely

2 total trials

Why NCT05435846 stopped before completion

NCT05435846 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Capmatinib is the first listed.

NCT05435846 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05435846 about?

NCT05435846 is a clinical study titled "Capmatinib Plus Trametinib for the Treatment of Metastatic Non-small Cell Lung Cancer With MET Exon 14 Skipping Mutation". This phase I/Ib trial studies the side effects and best doses of capmatinib plus trametinib when given together for the treatment of patients with MET exon 14 skipping mutation non-small cell lung cancer that has spread to other places in the body (metastatic). Capmatinib is in a class of medication...

What is the current status of trial NCT05435846?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2022-08-10. Estimated completion is 2024-05-31.

What interventions are being tested in trial NCT05435846?

The interventions under investigation include: Capmatinib (DRUG), Trametinib (DRUG).

Who is sponsoring clinical trial NCT05435846?

This trial is sponsored by Collin Blakely, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05435846's enrollment target sits among peer trials

3 1999th of 2000 higher than 1 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 NCT05435846, the US trial registry maintained by the National Library of Medicine. NCT05435846 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.