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



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 127
Updated:3/30/2019
Start Date:September 27, 2018
End Date:December 28, 2023
Contact:AstraZeneca Clinical Study Information Center
Email:information.center@astrazeneca.com
Phone:1-877-240-9479

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A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients With Limited Stage Small Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC)

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


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)
We found this trial at
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