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

Sponsor score: 40

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

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

  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

FACILITYZIPCITYSTATE
Research Site85715TucsonArizona
Research Site95403Santa RosaCalifornia
Research Site06510New HavenConnecticut
Research Site33901Fort MyersFlorida
Research Site32763Orange CityFlorida
Research Site33705St. PetersburgFlorida
Research Site30060MariettaGeorgia
Research Site60141HinesIllinois
Research Site46804Fort WayneIndiana
Research Site47303MuncieIndiana

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