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NCT02898116 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer
A Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT02898116: Completed Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
NCT02898116 is a Phase 1 study that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02898116, a Phase 1 study, has completed, sponsored by Ludwig Institute for Cancer Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This was a Phase 1/2, open-label, multicenter, single-arm study of combination therapy with ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor, and durvalumab, an anti-programmed cell death ligand 1 (PD-L1) antibody, in subjects with ALK-rearranged (ALK-positive) non-small cell lung cancer (NSCLC). Primary study objectives were to determine the recommended combination dose (RCD) and safety and tolerability of the combination. Further objectives were to evaluate the clinical efficacy and biologic activity of the combination.
Primary Outcome
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the end of the study period. Dose-limiting toxicity (DLT) during the Run-in Period was defined as ≥ Grade 2 rash or other toxicity requiring discontinuation of ensartinib dosing.
Interventions
- DRUG Durvalumab
- DRUG Ensartinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2017-05-10 |
| Est. Completion | 2017-08-04 |
| Phase | Phase 1 |
What the finished NCT02898116 record still lists
NCT02898116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Durvalumab is the first listed.
NCT02898116 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02898116 about?
NCT02898116 is a clinical study titled "Phase 1/2 Study of Ensartinib and Durvalumab, in ALK-rearranged Non-small Cell Lung Cancer". This was a Phase 1/2, open-label, multicenter, single-arm study of combination therapy with ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor, and durvalumab, an anti-programmed cell death ligand 1 (PD-L1) antibody, in subjects with ALK-rearranged (ALK-positive) non-small cell lung cancer (N...
What is the current status of trial NCT02898116?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2017-05-10. Estimated completion is 2017-08-04.
What interventions are being tested in trial NCT02898116?
The interventions under investigation include: Durvalumab (DRUG), Ensartinib (DRUG).
Who is sponsoring clinical trial NCT02898116?
This trial is sponsored by Ludwig Institute for Cancer Research, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02898116's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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