Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy
Sponsor: AstraZeneca
ClinicalTrials ID:NCT03703297
This Phase III trial evaluates Durvalumab, with or without Tremelimumab, versus placebo as consolidation therapy in LS-SCLC patients post-chemoradiation. Eligible participants have stage I-III LS-SCLC, completed chemoradiation with platinum and etoposide, and have not progressed. Interventions include IV infusions of Durvalumab, Tremelimumab, or placebo. Participants must have an ECOG score of 0 or 1.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III).
- Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to randomization and the first dose of IP. Chemotherapy must contain platinum and IV etoposide. Radiotherapy must be either total 60-66 Gy over 6 weeks for the standard QD regimen or total 45 Gy over 3 weeks for hyperfractionated BD schedules.
- PCI may be delivered at the discretion of investigator and local standard of care, and must be conducted after the end of cCRT and completed between 1 to 42 days to first dose of IP.
4 .Have not progressed following definitive concurrent chemoradiation 5 .Life expectancy ≥ 12 weeks at Day 1. 6. ECOG 0 or 1 at enrolment.
Exclusion Criteria
- Extensive-stage SCLC
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
- Active infection including tuberculosis, HIV, hepatitis B and C
- Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy)
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85715 | Tucson | Arizona |
| Research Site | 95403 | Santa Rosa | California |
| Research Site | 06510 | New Haven | Connecticut |
| Research Site | 33901 | Fort Myers | Florida |
| Research Site | 32763 | Orange City | Florida |
| Research Site | 33705 | St. Petersburg | Florida |
| Research Site | 30060 | Marietta | Georgia |
| Research Site | 60141 | Hines | Illinois |
| Research Site | 46804 | Fort Wayne | Indiana |
| Research Site | 47303 | Muncie | Indiana |
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