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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: Active Phase 1 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Each patient will have the KRAS mutation and PD-L1 status determined prior to treatment in order for stratified randomization. A futility monitoring will be carried out continuously to each stratum within each treatment arm after the primary endpoints of 6 patients have been observed in the corresponding marker groups.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2018-02-03 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What the registry record for NCT03225664 still lists
NCT03225664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (62% lower).
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 a single indexed study location in 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.
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 NCT03225664's enrollment target sits among peer trials
37 41st of 81 higher than 40 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.
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