Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer (CANTABRICO)
Primary Purpose
Small Cell Lung Carcinoma Extensive Disease
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Durvalumab
Cisplatin
Etoposide
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Carcinoma Extensive Disease focused on measuring Extensive-Stage, ICI, SCLC, Durvalumab
Eligibility 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 have been treated at least 2 weeks prior to study treatment and are currently receiving 10 mg/day or less of prednisone or equivalent.
- 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.
Sites / Locations
- Research Site
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Durvalumab in Combination with Platinum-Etoposide
Arm Description
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.
Outcomes
Primary Outcome Measures
Incidence of grade ≥ 3 Adverse Events (AE)
Incidence of Immune Mediated Adverse Events (imAE).
Secondary Outcome Measures
Progression Free Survival (PFS).
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)
PFS rate at 6 months (PFS6).
PFS at 6 months, defined as the proportion of participants remaining alive without disease progression at 6 months after initiation of study treatment.
PFS rate at 1 year (PFS12).
PFS at 1 year, defined as the proportion of participants remaining alive without disease progression at 1 year after initiation of study treatment.
Objective Response Rate (ORR): using site investigator assessments according to RECIST 1.1.
ORR, defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.
Duration of Response (DoR).
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.
DoR rate at 1 year (DoR12)
DoR at 1 year, defined as the proportion of participants having CR or PR (unconfirmed) at 1 year after initiation of study treatment.
Time to Treatment Discontinuation (TTD).
Defined as the time in months between first and last study treatment dose.
Overal Survival (OS).
OS, defined as the time from initiation of study treatment to death from any cause.
OS rate at 6 months.
OS at 6 months, defined as the proportion of participants remaining alive at 6 months after initiation of study treatment.
OS rate at 1 year.
OS at 1 year, defined as the proportion of participants remaining alive at 1 year after initiation of study treatment.
OS rate at 18 months.
OS at 18 months, defined as the proportion of participants remaining alive at 18 months after initiation of study treatment.
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).
Changes from baseline in PRO-CTCAE.
Number of visits to oncology service, emergency visits, outpatient visits, imaging tests and biopsy-related procedures and number and length of hospitalizations.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04712903
Brief Title
Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer
Acronym
CANTABRICO
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).
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
June 21, 2023 (Actual)
Study Completion Date
June 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Carcinoma Extensive Disease
Keywords
Extensive-Stage, ICI, SCLC, Durvalumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Durvalumab in Combination with Platinum-Etoposide
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Intervention Description
Durvalumab 1500 mg via IV infusion over 60 minutes on Day 1 of each cycle.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin as an IV infusion per local standards (usually over 60 to 120 minutes on Day 1) of each cycle.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Etoposide sequentially administered per local standards (usually over 30 to 60 minutes IV infusion) on Days 1, 2, and 3 of each cycle.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin as an IV infusion per local standards (usually over 30 to 60 minutes on Day 1) of each cycle.
Primary Outcome Measure Information:
Title
Incidence of grade ≥ 3 Adverse Events (AE)
Time Frame
Up to 18 months
Title
Incidence of Immune Mediated Adverse Events (imAE).
Time Frame
Up to 18 months
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS).
Description
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)
Time Frame
Up to 18 months
Title
PFS rate at 6 months (PFS6).
Description
PFS at 6 months, defined as the proportion of participants remaining alive without disease progression at 6 months after initiation of study treatment.
Time Frame
Up to 6 months
Title
PFS rate at 1 year (PFS12).
Description
PFS at 1 year, defined as the proportion of participants remaining alive without disease progression at 1 year after initiation of study treatment.
Time Frame
Up to 12 months
Title
Objective Response Rate (ORR): using site investigator assessments according to RECIST 1.1.
Description
ORR, defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.
Time Frame
Up to 18 months
Title
Duration of Response (DoR).
Description
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.
Time Frame
Up to 18 months
Title
DoR rate at 1 year (DoR12)
Description
DoR at 1 year, defined as the proportion of participants having CR or PR (unconfirmed) at 1 year after initiation of study treatment.
Time Frame
Up to 12 months
Title
Time to Treatment Discontinuation (TTD).
Description
Defined as the time in months between first and last study treatment dose.
Time Frame
Up to 18 months
Title
Overal Survival (OS).
Description
OS, defined as the time from initiation of study treatment to death from any cause.
Time Frame
Up to 18 months
Title
OS rate at 6 months.
Description
OS at 6 months, defined as the proportion of participants remaining alive at 6 months after initiation of study treatment.
Time Frame
Up to 6 months
Title
OS rate at 1 year.
Description
OS at 1 year, defined as the proportion of participants remaining alive at 1 year after initiation of study treatment.
Time Frame
Up to 12 months
Title
OS rate at 18 months.
Description
OS at 18 months, defined as the proportion of participants remaining alive at 18 months after initiation of study treatment.
Time Frame
Up to 18 months
Title
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
Title
Changes from baseline in PRO-CTCAE.
Time Frame
Up to 18 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 have been treated at least 2 weeks prior to study treatment and are currently receiving 10 mg/day or less of prednisone or equivalent.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dolores Isla, M.D.
Organizational Affiliation
Hospital Clínico Lozano Blesa, Zaragoza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Research Site
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Research Site
City
Badajoz
ZIP/Postal Code
6006
Country
Spain
Facility Name
Research Site
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
?08041
Country
Spain
Facility Name
Research Site
City
Castellon de la Plana
ZIP/Postal Code
12004
Country
Spain
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Research Site
City
Galdakao
ZIP/Postal Code
48960
Country
Spain
Facility Name
Research Site
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Research Site
City
Jaén
ZIP/Postal Code
23007
Country
Spain
Facility Name
Research Site
City
La Laguna
ZIP/Postal Code
38320
Country
Spain
Facility Name
Research Site
City
León
ZIP/Postal Code
24071
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Research Site
City
Mataro
ZIP/Postal Code
08304
Country
Spain
Facility Name
Research Site
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Research Site
City
Málaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Research Site
City
Ourense
ZIP/Postal Code
32005
Country
Spain
Facility Name
Research Site
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Research Site
City
Palma
ZIP/Postal Code
07198
Country
Spain
Facility Name
Research Site
City
Reus,Tarragona
ZIP/Postal Code
43204
Country
Spain
Facility Name
Research Site
City
San Sebastián
ZIP/Postal Code
20014
Country
Spain
Facility Name
Research Site
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Research Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Research Site
City
Toledo
ZIP/Postal Code
45004
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Research Site
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Facility Name
Research Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing 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
IPD Sharing 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
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer
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