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)
ClinicalTrials.gov processed this data on November 5, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
ACTIVE, NOT RECRUITING (See Contacts and Locations)Verified November 2024 by AstraZeneca
Sponsor
AstraZenecaInformation Provided by (Responsible Party)
AstraZenecaClinicaltrials.gov Identifier
NCT03703297Other Study ID Numbers: D933QC00001
First Submitted: September 19, 2018
First Posted: October 11, 2018
Last Update Posted: November 6, 2024
Last Verified: November 2024
History of Changes
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Study Description
Not Provided| Condition or Disease | Intervention/Treatment |
|---|---|
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Study Design
| Study Type | Interventional |
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| Actual Enrollment | 730 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Triple |
| Primary Purpose | Treatment |
| 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) |
| Study Start Date | September 27, 2018 |
| Anticipated Primary Completion Date | March 5, 2026 |
| Anticipated Study Completion Date | March 5, 2026 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- 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
- 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]
- Progression-free survival PFS [Approximately 6 years] To assess the efficacy of durvalumab and tremelimumab combination therapy compared to placebo in terms of PFS
- Progression-free survival at 18 months (PFS18) [Approximately 6 years]
- Progression-free survival at 24 months (PFS24) [Approximately 6 years]
- Time to death or distant metastasis (TTDM) [Approximately 6 years]
- Proportion of patients alive at 24 months (OS24) [Approximately 6 years]
- Proportion of patients alive at and 36 months (OS36) [Approximately 6 years]
- Time from randomization to second progression (PFS2) [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 the PK of durvalumab and tremelimumab in blood (peak trough concentration) [Approximately 6 years]
- Presence of anti-drug antibodies (ADA) for durvalumab and tremelimumab (confirmatory results: positive or negative) [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
- 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]
Eligibility Criteria
| Ages Eligible for Study | 18 Years to 130 Years (Adult, Older Adult) |
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| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| Inclusion Criteria |
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| Exclusion Criteria |
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Contacts and Locations
| Sponsors and Collaborators | AstraZeneca |
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More Information
Additional Information
Publications
Additional Relevant MeSH Terms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Neoplasms by Site
- Neoplasms
- Lung Diseases
- Respiratory Tract Diseases
- Carcinoma, Bronchogenic
- Bronchial Neoplasms