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NCT04837716 · ClinicalTrials.gov registry record · Phase 1
Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer
A Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04837716: Active Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT04837716 is a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 12 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04837716, a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib trial finds the best dose and side effects of ensartinib and its effects when given with carboplatin, pemetrexed and bevacizumab for in treating patients with ALK-positive non-small cell lung cancer that is stage IIIC or IV, or has come back (recurrent). Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as carboplatin and pemetrexed, 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. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving ensartinib, carboplatin, pemetrexed and bevacizumab may help to control the disease.
Primary Outcome
The toxicity rate will be estimated with their exact 95% confidence intervals.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Pemetrexed
- BIOLOGICAL Bevacizumab
- DRUG Ensartinib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-03-18 |
| Est. Completion | 2027-09-23 |
| Phase | Phase 1 |
What the registry record for NCT04837716 still lists
NCT04837716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 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 (88% lower).
The record links to 6 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT04837716 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04837716 about?
NCT04837716 is a clinical study titled "Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer". This phase Ib trial finds the best dose and side effects of ensartinib and its effects when given with carboplatin, pemetrexed and bevacizumab for in treating patients with ALK-positive non-small cell lung cancer that is stage IIIC or IV, or has come back (recurrent). Ensartinib may stop the growth ...
What is the current status of trial NCT04837716?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2021-03-18. Estimated completion is 2027-09-23.
What conditions does trial NCT04837716 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Metastatic Lung Non-Small Cell Carcinoma, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Recurrent Lung Non-Small Cell Carcinoma.
What interventions are being tested in trial NCT04837716?
The interventions under investigation include: Carboplatin (DRUG), Pemetrexed (DRUG), Bevacizumab (BIOLOGICAL), Ensartinib (DRUG).
Who is sponsoring clinical trial NCT04837716?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04837716 being conducted?
This trial has 1 study location across 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 NCT04837716's enrollment target sits among peer trials
12 72nd of 81 higher than 9 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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