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NCT02460367 · ClinicalTrials.gov registry record · Phase 1
Immunotherapy Combination Study in Advanced Previously Treated Non-Small Cell Lung Cancer
A Phase 1 study, sponsored by NewLink Genetics Corporation.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT02460367: Clinical Trial Phase 1 study, sponsored by NewLink Genetics Corporation.
NCT02460367 is a Phase 1 study that was terminated before completion, run by NewLink Genetics Corporation. 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
NCT02460367, a Phase 1 study, was terminated before completion, sponsored by NewLink Genetics Corporation.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is a Phase 1/2 trial using indoximod, an inhibitor of the immune "checkpoint" pathway indoleamine 2,3-dioxygenase (IDO), in combination with Tergenpumatucel-L immunotherapy and Docetaxel to treat subjects with advanced Non-Small Cell Lung Cancer (NSCLC). From a practical standpoint, a successful tumor immunotherapy will likely require a combination treatment with additional therapeutic interventions that both activate an immune response and remove redundant mechanisms of tolerance maintenance. This clinical trial utilizes the combination of the chemotherapeutic agent, docetaxel, plus two investigational methods of cancer immunotherapy: the first, tergenpumatucel-L, is intended to educate the human immune system to recognize the abnormal components found in lung cancer cells, resulting in an immune response intended to destroy or block the growth of the cancer; and the second, the IDO inhibitor Indoximod, will overcome tumor-induced immune suppression. The goal of this study is to assess the progression-free survival (PFS) and overall survival (OS) rates in this patient population. This study will provide a foundation for future trials testing indoximod combined with tergenpumatucel-L.
Primary Outcome
Phase 1 component: To identify the regimen limiting toxicity (RLT) for the combination of tergenpumatucel-L and indoximod.
Interventions
- DRUG Docetaxel
- DRUG Indoximod
- BIOLOGICAL Tergenpumatucel-L
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2016-01 |
| Est. Completion | 2021-01-13 |
| Phase | Phase 1 |
Why NCT02460367 stopped before completion
NCT02460367 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 3 interventions - of which Docetaxel is the first listed.
NCT02460367 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02460367 about?
NCT02460367 is a clinical study titled "Immunotherapy Combination Study in Advanced Previously Treated Non-Small Cell Lung Cancer". This is a Phase 1/2 trial using indoximod, an inhibitor of the immune "checkpoint" pathway indoleamine 2,3-dioxygenase (IDO), in combination with Tergenpumatucel-L immunotherapy and Docetaxel to treat subjects with advanced Non-Small Cell Lung Cancer (NSCLC). From a practical standpoint, a successfu...
What is the current status of trial NCT02460367?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2016-01. Estimated completion is 2021-01-13.
What interventions are being tested in trial NCT02460367?
The interventions under investigation include: Docetaxel (DRUG), Indoximod (DRUG), Tergenpumatucel-L (BIOLOGICAL).
Who is sponsoring clinical trial NCT02460367?
This trial is sponsored by NewLink Genetics Corporation, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02460367'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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