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

Status: Active

Description

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 Stage I-III LD-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 concurrent chemoradiotherapy consisting of chemotherapy - etoposide/platinum; and radiotherapy - either 60-66Gy for standard QD regimen or 45Gy for hyperfractionated BID regimen.
  • Have not progressed following definitive concurrent chemoradiation 4 .Life expectancy ≥ 12 weeks at Day 1. 5. 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 & Contacts

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
AstraZeneca Pharmaceuticals LP

Trial IDs

Primary ID D933QC00001
Secondary IDs NCI-2019-01390
Clinicaltrials.gov ID NCT03703297