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

Small Cell Lung Carcinoma Extensive Disease Clinical Trial

— 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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04712903
• Other study ID #: D419QC00005
• Secondary ID: 2020-002328-35
• Status: Completed
• Phase: Phase 3
• Start date: December 16, 2020
• Est. completion date: June 21, 2023

Study information

• Verified date: July 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 21, 2023
• Est. primary completion date: June 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Small Cell Lung Carcinoma
• Small Cell Lung Carcinoma Extensive Disease

Intervention

Drug:
• Durvalumab
Durvalumab 1500 mg via IV infusion over 60 minutes on Day 1 of each cycle.
• Cisplatin
Cisplatin as an IV infusion per local standards (usually over 60 to 120 minutes on Day 1) of each cycle.
• Etoposide
Etoposide sequentially administered per local standards (usually over 30 to 60 minutes IV infusion) on Days 1, 2, and 3 of each cycle.
• Carboplatin
Carboplatin as an IV infusion per local standards (usually over 30 to 60 minutes on Day 1) of each cycle.

Locations

Country	Name	City	State
Spain	Research Site	A Coruna
Spain	Research Site	Alicante
Spain	Research Site	Badajoz
Spain	Research Site	Badalona
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Castellon de la Plana
Spain	Research Site	Córdoba
Spain	Research Site	Galdakao
Spain	Research Site	Granada
Spain	Research Site	Jaén
Spain	Research Site	La Laguna
Spain	Research Site	León
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Majadahonda
Spain	Research Site	Málaga
Spain	Research Site	Mataro
Spain	Research Site	Murcia
Spain	Research Site	Ourense
Spain	Research Site	Oviedo
Spain	Research Site	Palma
Spain	Research Site	Reus,Tarragona
Spain	Research Site	San Sebastián
Spain	Research Site	Santander
Spain	Research Site	Santiago de Compostela
Spain	Research Site	Toledo
Spain	Research Site	Valencia
Spain	Research Site	Valladolid
Spain	Research Site	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of grade = 3 Adverse Events (AE)		Up to 18 months
Primary	Incidence of Immune Mediated Adverse Events (imAE).		Up to 18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to Treatment Discontinuation (TTD).	Defined as the time in months between first and last study treatment dose.	Up to 18 months
Secondary	Overal Survival (OS).	OS, defined as the time from initiation of study treatment to death from any cause.	Up to 18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes from baseline in PRO-CTCAE.		Up to 18 months
Secondary	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