Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT03703297

Run by

AstraZeneca

People needed

730

Starts

2018-09-27

Expected to finish

2026-10-23

Last updated by the study team

2025-11-21

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Research Site — Santa Rosa, California, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Fort Myers, Florida, United States
• Research Site — Orange City, Florida, United States
• Research Site — St. Petersburg, Florida, United States
• Research Site — Marietta, Georgia, United States
• Research Site — Hines, Illinois, United States
• Research Site — Fort Wayne, Indiana, United States
• Research Site — Muncie, Indiana, United States
• Research Site — Lexington, Kentucky, United States
• Research Site — Annapolis, Maryland, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Towson, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Grand Rapids, Michigan, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — Summit, New Jersey, United States
• Research Site — New Hyde Park, New York, United States
• Research Site — Chapel Hill, North Carolina, United States
• Research Site — Portland, Oregon, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Sioux Falls, South Dakota, United States
• Research Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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