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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03237377
The ClinicalTrials.gov registry entry for NCT03237377 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Durvalumab is the first listed.
NCT03237377 reports 0 study locations.
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.
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