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
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
- 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.
- 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
Name Not Available
Trial Phase & Type
AstraZeneca Pharmaceuticals LP
Secondary IDs NCI-2019-01390
Clinicaltrials.gov ID NCT03703297