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

Phase 3

Active, not recruiting

• Conditions: Small Cell Lung Cancer
• Interventions: Other: Placebo; Drug: Durvalumab; Drug: Tremelimumab

• Registration Number: NCT03703297
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-19
• Study Start: 2018-09-27
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-03-05
• Study Completion: 2026-03-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 730

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + Placebo	Placebo	Placebo: Placebo saline solution (IV) q4w in combination with a second placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by a single placebo saline solution q4w. The first placebo saline solution monotherapy dose q4w will be 4 weeks after the final dose of the 2 placebo saline solutions in combination.
Durvalumab + Placebo	Placebo	Durvalumab monotherapy: Durvalumab (1500 mg intravenous \[IV\]) q4w in combination with placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with placebo saline solution.
Durvalumab + Placebo	Durvalumab	Durvalumab monotherapy: Durvalumab (1500 mg intravenous \[IV\]) q4w in combination with placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with placebo saline solution.
Durvalumab + Tremelimumab	Durvalumab	Durvalumab in combination with tremelimumab: Durvalumab (1500 mg IV) q4w in combination with tremelimumab (75 mg IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with tremelimumab.
Durvalumab + Tremelimumab	Tremelimumab	Durvalumab in combination with tremelimumab: Durvalumab (1500 mg IV) q4w in combination with tremelimumab (75 mg IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with tremelimumab.

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Approximately 6 years	To assess the efficacy of Durvalumab monotherapy vs Placebo in terms of PFS
Overall Survival (OS)	Approximately 6 years	To assess the efficacy of Durvalumab monotherapy vs Placebo in terms of OS

Secondary Outcome Measures

Name	Time	Method
Proportion of patients alive at and 36 months (OS36)	Approximately 6 years
Overall Survival (OS)	Approximately 6 years	To assess the efficacy of Durvalumab \& Tremelimumab combination therapy vs Placebo in terms of OS
Objective Response Rate (ORR)	Approximately 6 years
PD-L1 expression in tumor and/or immune cells relative to response/efficacy outcomes (PFS, OS & ORR).	Approximately 6 years	To investigate the relationship between PDL1 expression \& spatial distribution with Durva (mono) therapy \& Durva+Treme (combination) therapy
Time to death or distant metastasis (TTDM)	Approximately 6 years
Presence of anti-drug antibodies (ADA) for durvalumab and tremelimumab (confirmatory results: positive or negative)	Approximately 6 years
Progression-free survival at 18 months (PFS18)	Approximately 6 years
Progression-free survival at 24 months (PFS24)	Approximately 6 years
To assess the PK of durvalumab and tremelimumab in blood (peak trough concentration)	Approximately 6 years
Progression-free survival PFS	Approximately 6 years	To assess the efficacy of durvalumab and tremelimumab combination therapy compared to placebo in terms of PFS
Time from randomization to second progression (PFS2)	Approximately 6 years
Proportion of patients alive at 24 months (OS24)	Approximately 6 years
To assess symptoms and health-related QoL in patients treated withdurvalumab or durvalumab and tremelimumab combination therapy compared to placebo using the EORTC QLQ-C30 v3	Approximately 6 years
To assess symptoms and health-related QoL in patients treated withdurvalumab or durvalumab and tremelimumab combination therapy compared to placebo using the EORTC QLQ-LC13	Approximately 6 years

Trial Locations

Locations (1)

Research Site; 🇻🇳 Ho Chi Minh, Vietnam