Clinical Trials /

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

NCT03703297

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 LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Related Conditions:
  • Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: D933QC00001
  • NCT ID: NCT03703297

Conditions

  • Small Cell Lung Cancer

Interventions

DrugSynonymsArms
DurvalumabMEDI4736Durvalumab + Placebo
TremelimumabDurvalumab + Tremelimumab

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Durvalumab + PlaceboExperimentalDurvalumab 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
Durvalumab + TremelimumabExperimentalDurvalumab 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
Placebo + PlaceboPlacebo ComparatorPlacebo: 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.

    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)
          
    Maximum Eligible Age:130 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Progression-free survival (PFS)
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Overall Survival (OS)
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:
    Measure:Objective Response Rate (ORR)
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:
    Measure:Progression-free survival PFS
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:
    Measure:Progression-free survival at 18 months (PFS18)
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:
    Measure:Progression-free survival at 24 months (PFS24)
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:
    Measure:Time to death or distant metastasis (TTDM)
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:
    Measure:Proportion of patients alive at 24 months (OS24)
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:
    Measure:Proportion of patients alive at and 36 months (OS36)
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:
    Measure:Time from randomization to second progression (PFS2)
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:
    Measure: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
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:
    Measure:To assess the PK of durvalumab and tremelimumab in blood (peak trough concentration)
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:
    Measure:Presence of anti-drug antibodies (ADA) for durvalumab and tremelimumab (confirmatory results: positive or negative)
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:
    Measure:To assess a relationship between a tumor mutational burden (TMB) measured as biomarker presence in tumor and/or blood and Progression-free survival (PFS) with durvalumab and durvalumab and tremelimumab combination therapy
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:
    Measure: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
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:
    Measure:To assess a relationship between a tumor mutational burden (TMB) measured as biomarker presence in tumor and/or blood and Objective Response Rate (ORR) with durvalumab and durvalumab and tremelimumab combination therapy
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:
    Measure:To assess a relationship between a tumor mutational burden (TMB) measured as biomarker presence in tumor and/or blood and Overall Survival (OS) with durvalumab and durvalumab and tremelimumab combination therapy
    Time Frame:Approximately 5 years
    Safety Issue:
    Description:

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:AstraZeneca

    Trial Keywords

    • Small Cell Lung Cancer
    • SCLC
    • LS-SCLC
    • Limited Stage
    • Carcinoma
    • Lung Cancer

    Last Updated