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NCT03237377 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Immunoradiation for Resectable Non-Small Cell Lung Cancer
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT03237377: Clinical Trial Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT03237377 is a Phase 2 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03237377, a Phase 2 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is a pilot study of neoadjuvant 'immunoradiation' (durvalumab or durvalumab plus tremelimumab) administered every 4 weeks for 2 doses, concurrently with standard thoracic radiation (RT) (45Gy in 25 fractions), with one dose of immunotherapy alone delivered in the pre-surgical window, prior to surgical resection, for patients with stage IIIA NSCLC that is deemed resectable with a lobectomy by a thoracic surgeon. If preliminary safety of the durvalumab/thoracic RT combination is established, a second cohort investigating the combination of durvalumab/tremelimumab/thoracic RT prior to surgical resection will be opened. After surgical resection, patients may receive standard adjuvant chemotherapy, as deemed appropriate by the treating investigator.
Primary Outcome
Number of participants experiencing adverse events as defined by CTCAE v4.0.
Interventions
- DRUG Durvalumab
- DRUG Tremelimumab
- PROCEDURE lobectomy
- RADIATION Thoracic Radiation
- DRUG Standard of care adjuvant chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2017-12-12 |
| Est. Completion | 2024-05-23 |
| Phase | Phase 2 |
Why NCT03237377 stopped before completion
NCT03237377 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 5 interventions - of which Durvalumab is the first listed.
NCT03237377 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03237377 about?
NCT03237377 is a clinical study titled "Neoadjuvant Immunoradiation for Resectable Non-Small Cell Lung Cancer". This is a pilot study of neoadjuvant 'immunoradiation' (durvalumab or durvalumab plus tremelimumab) administered every 4 weeks for 2 doses, concurrently with standard thoracic radiation (RT) (45Gy in 25 fractions), with one dose of immunotherapy alone delivered in the pre-surgical window, prior to s...
What is the current status of trial NCT03237377?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2017-12-12. Estimated completion is 2024-05-23.
What interventions are being tested in trial NCT03237377?
The interventions under investigation include: Durvalumab (DRUG), Tremelimumab (DRUG), lobectomy (PROCEDURE), Thoracic Radiation (RADIATION), Standard of care adjuvant chemotherapy (DRUG).
Who is sponsoring clinical trial NCT03237377?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03237377's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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