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Trial record 1 of 2 for:    durvalumab | SCLC, Limited Stage
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Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC)

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ClinicalTrials.gov Identifier: NCT03703297
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Durvalumab Drug: Tremelimumab Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 724 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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)
Actual Study Start Date : September 27, 2018
Estimated Primary Completion Date : May 10, 2024
Estimated Study Completion Date : May 10, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Durvalumab + 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.
 Drug: Durvalumab
Durvalumab IV (intravenous infusion)
Other Name: MEDI4736

Other: Placebo
Placebo IV (intravenous infusion)
Experimental: Durvalumab + 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.
 Drug: Durvalumab
Durvalumab IV (intravenous infusion)
Other Name: MEDI4736

Drug: Tremelimumab
Tremelimumab IV (intravenous infusion)
Placebo Comparator: 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.
 Other: Placebo
Placebo IV (intravenous infusion)


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Approximately 4 years ]
    To assess the efficacy of Durvalumab monotherapy vs Placebo in terms of PFS

  2. Overall Survival (OS) [ Time Frame: Approximately 6 years ]
    To assess the efficacy of Durvalumab monotherapy vs Placebo in terms of OS


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Approximately 6 years ]
    To assess the efficacy of Durvalumab & Tremelimumab combination therapy vs Placebo in terms of OS

  2. Objective Response Rate (ORR) [ Time Frame: Approximately 6 years ]
  3. Progression-free survival PFS [ Time Frame: Approximately 4 years ]
    To assess the efficacy of durvalumab and tremelimumab combination therapy compared to placebo in terms of PFS

  4. Progression-free survival at 18 months (PFS18) [ Time Frame: Approximately 4 years ]
  5. Progression-free survival at 24 months (PFS24) [ Time Frame: Approximately 4 years ]
  6. Time to death or distant metastasis (TTDM) [ Time Frame: Approximately 6 years ]
  7. Proportion of patients alive at 24 months (OS24) [ Time Frame: Approximately 6 years ]
  8. Proportion of patients alive at and 36 months (OS36) [ Time Frame: Approximately 6 years ]
  9. Time from randomization to second progression (PFS2) [ Time Frame: Approximately 6 years ]
  10. 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 6 years ]
  11. To assess the PK of durvalumab and tremelimumab in blood (peak trough concentration) [ Time Frame: Approximately 6 years ]
  12. Presence of anti-drug antibodies (ADA) for durvalumab and tremelimumab (confirmatory results: positive or negative) [ Time Frame: Approximately 6 years ]
  13. PD-L1 expression in tumor and/or immune cells relative to response/efficacy outcomes (PFS, OS & ORR). [ Time Frame: Approximately 6 years ]
    To investigate the relationship between PDL1 expression & spatial distribution with Durva (mono) therapy & Durva+Treme (combination) therapy

  14. 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 6 years ]

Other Outcome Measures:
  1. Adverse Events [ Time Frame: Approximately 6 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703297


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: AstraZeneca Cancer Study, Local service 1-877-400-4656 AstraZeneca@emergingmed.com

Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Haiyi Jiang, M.D. AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03703297    
Other Study ID Numbers: D933QC00001
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Small Cell Lung Cancer
SCLC
LS-SCLC
 Limited Stage
Carcinoma
Lung Cancer
Additional relevant MeSH terms:
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Small Cell Lung Carcinoma
Durvalumab
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Tremelimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents