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Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer (CANTABRICO)

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ClinicalTrials.gov Identifier: NCT04712903
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
This is a Phase IIIb, interventional, single arm, multicentre study to evaluate safety, effectivenees, use of resources and patient reporting outcomes in patients with ES-SCLC treated with durvalumab in combination with platinum-etoposide as first-line treatment in Spain.

Condition or disease Intervention/treatment Phase
Small Cell Lung Carcinoma Extensive Disease Drug: Durvalumab Drug: Cisplatin Drug: Etoposide Drug: Carboplatin Phase 3

Detailed Description:

This trial will provide an opportunity to further evaluate the safety profile and efficacy of durvalumab + EP in patient population that is reflective of real-world clinical practice, Durvalumab will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered as monotherapy post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity.

Prophylactic cranial irradiation (PCI) is allowed in patients showing complete or partial responses after the durvalumab + EP combination cycles, at the discretion of the investigator according to their local clinical practice.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIIB, Single Arm Study, of Durvalumab in Combination With Platinum-Etoposide for Untreated Patients With Extensive-Stage Small Cell Lung Cancer Reflecting Real World Clinical Practice in Spain (CANTABRICO)
Actual Study Start Date : December 16, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Durvalumab in Combination with Platinum-Etoposide
Durvalumab 1500 mg via IV infusion will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity.
 Drug: Durvalumab
Durvalumab 1500 mg via IV infusion on Day 1 of each cycle.

Drug: Cisplatin
Cisplatin as an IV infusion over 60 minutes on Day 1 of each cycle.

Drug: Etoposide
Etoposide sequentially administered by a 60-minute IV infusion on Days 1, 2, and 3 of each cycle.

Drug: Carboplatin
Carboplatin as an IV infusion over 60 minutes on Day 1 of each cycle.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of grade ≥ 3 Adverse Events (AE) [ Time Frame: Up to 18 months ]
  2. Incidence of Immune Mediated Adverse Events (imAE). [ Time Frame: Up to 18 months ]

Secondary Outcome Measures :
  1. Progression Free Survival (PFS). [ Time Frame: Up to 18 months ]
    PFS, defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

  2. PFS rate at 6 months (PFS6). [ Time Frame: Up to 6 months ]
    PFS at 6 months, defined as the proportion of participants remaining alive without disease progression at 6 months after initiation of study treatment.

  3. PFS rate at 1 year (PFS12). [ Time Frame: Up to 12 months ]
    PFS at 1 year, defined as the proportion of participants remaining alive without disease progression at 1 year after initiation of study treatment.

  4. Objective Response Rate (ORR): using site investigator assessments according to RECIST 1.1. [ Time Frame: Up to 18 months ]
    ORR, defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.

  5. Duration of Response (DoR). [ Time Frame: Up to 18 months ]
    Duration of response (DOR), defined as the time from initial response to disease progression or death among patients who have experienced a CR or PR (unconfirmed) during the study. Duration of response will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.

  6. DoR rate at 1 year (DoR12) [ Time Frame: Up to 12 months ]
    DoR at 1 year, defined as the proportion of participants having CR or PR (unconfirmed) at 1 year after initiation of study treatment.

  7. Time to Treatment Discontinuation (TTD). [ Time Frame: Up to 18 months ]
    Defined as the time in months between first and last study treatment dose.

  8. Overal Survival (OS). [ Time Frame: Up to 18 months ]
    OS, defined as the time from initiation of study treatment to death from any cause.

  9. OS rate at 6 months. [ Time Frame: Up to 6 months ]
    OS at 6 months, defined as the proportion of participants remaining alive at 6 months after initiation of study treatment.

  10. OS rate at 1 year. [ Time Frame: Up to 12 months ]
    OS at 1 year, defined as the proportion of participants remaining alive at 1 year after initiation of study treatment.

  11. OS rate at 18 months. [ Time Frame: Up to 18 months ]
    OS at 18 months, defined as the proportion of participants remaining alive at 18 months after initiation of study treatment.

  12. Change from baseline in symptoms and quality of life as assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30) and Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13). [ Time Frame: Up to 18 months ]
  13. Changes from baseline in PRO-CTCAE. [ Time Frame: Up to 18 months ]
  14. Number of visits to oncology service, emergency visits, outpatient visits, imaging tests and biopsy-related procedures and number and length of hospitalizations. [ Time Frame: Up to 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Histologically or cytologically documented Small cell Lung Cancer with extensive disease.
  • Patients who had received chemoradiotherapy for LS-SCLC and have experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle, can be included under investigator criteria.
  • Brain metastases; must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment.
  • Patients must be considered suitable to receive a platinum-based chemotherapy regimen as 1st line treatment for ES-SCLC.
  • ECOG Performance Status of 0-2 at enrolment.
  • No prior exposure to immune-mediated therapy for cancer.
  • Adequate hematologic and organ function.
  • Life expectancy of at least 12 weeks.
  • Body weight >30 kg.

Exclusion Criteria:

  • Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy (except paliative care outside of the chest).
  • Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS
  • Active infection including tuberculosis, HIV, hepatitis B anc C
  • Active or prior documented autoimmune or inflammatory disorders
  • Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
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): NCT04712903


Contacts
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Contact: AstraZeneca Clinical Study Information Center, M.D. 1-877-240-9479 information.center@astrazeneca.com
Contact: José L García, M.D. 0034679943705 joseluis.garcia@astrazeneca.com

Locations
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Spain
Research Site Recruiting
A Coruna, Spain, 15006
Research Site Recruiting
Madrid, Spain, 28034
Research Site Recruiting
Ourense, Spain, 32005
Research Site Not yet recruiting
Palma, Spain, 07198
Research Site Not yet recruiting
Zaragoza, Spain, 50009
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Dolores Isla, M.D. Hospital Clínico Lozano Blesa, Zaragoza
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04712903    
Other Study ID Numbers: D419QC00005
2020-002328-35 ( EudraCT Number )
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: January 15, 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 refer 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
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AstraZeneca:
Extensive-Stage
ICI
SCLC
Durvalumab
Additional relevant MeSH terms:
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Small Cell Lung Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carboplatin
Etoposide
Durvalumab
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological