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

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).

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.

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Carcinoma Extensive Disease
• Intervention / Treatment: Drug: Durvalumab; Drug: Cisplatin; Drug: Etoposide; Drug: Carboplatin

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • A Coruna, Spain, 15006
    • Research Site
  • Alicante, Spain, 03010
    • Research Site
  • Badajoz, Spain, 6006
    • Research Site
  • Badalona, Spain, 08916
    • Research Site
  • Barcelona, Spain, 08036
    • Research Site
  • Barcelona, Spain, ?08041
    • Research Site
  • Barcelona, Spain, 08908
    • Research Site
  • Barcelona, Spain, 8003
    • Research Site
  • Castellon de la Plana, Spain, 12004
    • Research Site
  • Córdoba, Spain, 14004
    • Research Site
  • Galdakao, Spain, 48960
    • Research Site
  • Granada, Spain, 18014
    • Research Site
  • Jaén, Spain, 23007
    • Research Site
  • La Laguna, Spain, 38320
    • Research Site
  • León, Spain, 24071
    • Research Site
  • Madrid, Spain, 28034
    • Research Site
  • Madrid, Spain, 28041
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Madrid, Spain, 28027
    • Research Site
  • Majadahonda, Spain, 28222
    • Research Site
  • Mataro, Spain, 08304
    • Research Site
  • Murcia, Spain, 30008
    • Research Site
  • Málaga, Spain, 29011
    • Research Site
  • Ourense, Spain, 32005
    • Research Site
  • Oviedo, Spain, 33011
    • Research Site
  • Palma, Spain, 07198
    • Research Site
  • Reus,Tarragona, Spain, 43204
    • Research Site
  • San Sebastián, Spain, 20014
    • Research Site
  • Santander, Spain, 39008
    • Research Site
  • Santiago de Compostela, Spain, 15706
    • Research Site
  • Toledo, Spain, 45004
    • Research Site
  • Valencia, Spain, 46026
    • Research Site
  • Valladolid, Spain, 47003
    • Research Site
  • Zaragoza, Spain, 50009
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 over 60 minutes on Day 1 of each cycle.; Drug: Cisplatin; Cisplatin as an IV infusion per local standards (usually over 60 to 120 minutes on Day 1) of each cycle.; Drug: Etoposide; Etoposide sequentially administered per local standards (usually over 30 to 60 minutes IV infusion) on Days 1, 2, and 3 of each cycle.; Drug: Carboplatin; Carboplatin as an IV infusion per local standards (usually over 30 to 60 minutes on Day 1) of each cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of grade ≥ 3 Adverse Events (AE)	Up to 18 months
Incidence of Immune Mediated Adverse Events (imAE).	Up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Up to 18 months
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.	Up to 6 months
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.	Up to 12 months
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.	Up to 18 months
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.	Up to 18 months
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.	Up to 12 months
Time to Treatment Discontinuation (TTD).	Defined as the time in months between first and last study treatment dose.	Up to 18 months
Overal Survival (OS).	OS, defined as the time from initiation of study treatment to death from any cause.	Up to 18 months
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.	Up to 6 months
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.	Up to 12 months
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.	Up to 18 months
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).		Up to 18 months
Changes from baseline in PRO-CTCAE.		Up to 18 months
Number of visits to oncology service, emergency visits, outpatient visits, imaging tests and biopsy-related procedures and number and length of hospitalizations.		Up to 18 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Dolores Isla, M.D., Hospital Clínico Lozano Blesa, Zaragoza

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2020
• Primary Completion (Actual): June 21, 2023
• Study Completion (Actual): June 21, 2023

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Durvalumab; SCLC; ICI; Extensive-Stage
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Carboplatin; Etoposide; Durvalumab
• Other Study ID Numbers: D419QC00005; 2020-002328-35 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• 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