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NCT01912625 · ClinicalTrials.gov registry record · Phase 1
Trametinib, Combination Chemotherapy, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01912625: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01912625 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01912625, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and the best dose of trametinib when given together with combination chemotherapy and radiation therapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells. Giving trametinib, combination chemotherapy, and radiation therapy may be a better treatment for non-small cell lung cancer.
Primary Outcome
Toxicity will be tabulated by dose, type, and grade. The probability of toxicity over 70 days as a function of dose will be estimated by fitting a Bayesian binary outcome regression model.
Interventions
- DRUG Carboplatin
- OTHER Laboratory Biomarker Analysis
- RADIATION Intensity-Modulated Radiation Therapy
- RADIATION Image Guided Radiation Therapy
- RADIATION 3-Dimensional Conformal Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-10-28 |
| Est. Completion | 2023-02-24 |
| Phase | Phase 1 |
Why NCT01912625 stopped before completion
NCT01912625 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT01912625 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01912625 about?
NCT01912625 is a clinical study titled "Trametinib, Combination Chemotherapy, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery". This phase I trial studies the side effects and the best dose of trametinib when given together with combination chemotherapy and radiation therapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery. Trametinib may stop the growth of tumor cells by block...
What is the current status of trial NCT01912625?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2013-10-28. Estimated completion is 2023-02-24.
What interventions are being tested in trial NCT01912625?
The interventions under investigation include: Carboplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Intensity-Modulated Radiation Therapy (RADIATION), Image Guided Radiation Therapy (RADIATION), 3-Dimensional Conformal Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT01912625?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01912625's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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