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

NCT03703297

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Small Cell Lung Cancer

Interventions: Durvalumab, Tremelimumab, Placebo

Countries: United States, Argentina, Belgium, Canada, China, Czechia, Germany, India

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 overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria:

1. Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III).
2. 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.
3. 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:

1. Extensive-stage SCLC
2. Active or prior documented autoimmune or inflammatory disorders
3. Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
4. Active infection including tuberculosis, HIV, hepatitis B and C
5. Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy)

Locations (183)

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