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

NCT04712903 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: D419QC000052020-002328-35
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 34

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.

Conditions

Small Cell Lung Carcinoma Extensive Disease

Keywords

Extensive-Stage; ICI; SCLC; Durvalumab

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Adverse Events (AEs) Grade ≥ 3

  Patients with AEs grade ≥ 3 acording to NCI CTCAE v5.0

  During study treatment, until disease progression (median 6 months)

• Number of Patients With Immune-mediated Adverse Events (imAE)

  Patients with immune-mediated adverse events (imAE) per patient

  During study treatment, until disease progression (median 6 months)

Secondary Outcomes (36)

• Progression Free Survival (PFS).

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

• Objetive Response Rate (ORR)

  At least every 12 weeks, up to 18 monts

• Duration of Response (DoR)

  From the date of first documented response until the first date of documented progression or death in the absence of disease progression, assessed up to 2 years.

• Time to Treatment Discontinuation (TTD)

  From the first date of treatment until the end of treatment date, assessed up to 2 years.

• Overal Survival (OS)

  From date of inclusion until the date of death, assessed up to 30 months

Study Arms (1)

Durvalumab in Combination with Platinum-Etoposide

EXPERIMENTAL

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; Drug: Cisplatin; Drug: Etoposide; Drug: Carboplatin

Interventions

Durvalumab DRUG

Durvalumab 1500 mg via IV infusion over 60 minutes on Day 1 of each cycle.

Durvalumab in Combination with Platinum-Etoposide

Cisplatin DRUG

Cisplatin as an IV infusion per local standards (usually over 60 to 120 minutes on Day 1) of each cycle.

Durvalumab in Combination with Platinum-Etoposide

Etoposide DRUG

Etoposide sequentially administered per local standards (usually over 30 to 60 minutes IV infusion) on Days 1, 2, and 3 of each cycle.

Durvalumab in Combination with Platinum-Etoposide

Carboplatin DRUG

Carboplatin as an IV infusion per local standards (usually over 30 to 60 minutes on Day 1) of each cycle.

Durvalumab in Combination with Platinum-Etoposide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (34)

Research Site

A Coruña, 15006, Spain

Location

Research Site

Alicante, 03010, Spain

Location

Research Site

Badajoz, 6006, Spain

Location

Research Site

Badalona, 08916, Spain

Location

Research Site

Barcelona, 08036, Spain

Location

Research Site

Barcelona, 08908, Spain

Location

Research Site

Barcelona, 8003, Spain

Location

Research Site

Barcelona, ?08041, Spain

Location

Research Site

Castellon, 12004, Spain

Location

Research Site

Córdoba, 14004, Spain

Location

Research Site

Galdakao, 48960, Spain

Location

Research Site

Granada, 18014, Spain

Location

Research Site

Jaén, 23007, Spain

Location

Research Site

León, 24071, Spain

Location

Research Site

Madrid, 28027, Spain

Location

Research Site

Madrid, 28034, Spain

Location

Research Site

Madrid, 28040, Spain

Location

Research Site

Madrid, 28041, Spain

Location

Research Site

Majadahonda, 28222, Spain

Location

Research Site

Mataró, 08304, Spain

Location

Research Site

Málaga, 29011, Spain

Location

Research Site

Murcia, 30008, Spain

Location

Research Site

Ourense, 32005, Spain

Location

Research Site

Oviedo, 33011, Spain

Location

Research Site

Palma, 07198, Spain

Location

Research Site

Reus,Tarragona, 43204, Spain

Location

Research Site

San Cristóbal de La Laguna, 38320, Spain

Location

Research Site

San Sebastián, 20014, Spain

Location

Research Site

Santander, 39008, Spain

Location

Research Site

Santiago de Compostela, 15706, Spain

Location

Research Site

Toledo, 45004, Spain

Location

Research Site

Valencia, 46026, Spain

Location

Research Site

Valladolid, 47003, Spain

Location

Research Site

Zaragoza, 50009, Spain

Location

Related Publications (1)

• Isla D, Zugazagoitia J, Arriola E, Garcia-Campelo R, Marti Blanco C, Diz-Tain MP, Lopez-Brea M, Moreno-Vega AL, Leon-Mateos L, Oramas J, Gutierrez-Calderon V, Majem M, Sanchez-Hernandez A, Aguado C, Alvarez-Cabellos R, Massuti B, Moreno A, Firvida-Perez JL, Valdivia J, Gonzalez-Cordero M, Zafra-Poves M, Domine M, Garcia-Navalon FJ, Villanueva N, Provencio M, Juan-Vidal O, Rivas-Corredor C, Olmedo Garcia ME, Palmero R, Lopez-Castro R, Carcereny E, Lechuga JL, Dominguez M, Callejo A, Paz-Ares L. Durvalumab plus platinum-etoposide in the first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): A single-arm clinical trial. Lung Cancer. 2025 Nov;209:108763. doi: 10.1016/j.lungcan.2025.108763. Epub 2025 Sep 24.

  PMID: 41033130 DERIVED

Related Links

• CSR Synopsis
• SAP
• Protocol

MeSH Terms

Interventions

durvalumab; Cisplatin; Etoposide; Carboplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Coordination Complexes

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• Dolores Isla, M.D.

  Hospital Clínico Lozano Blesa, Zaragoza

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: January 15, 2021
• Study Start: December 16, 2020
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2023
• Last Updated: January 7, 2025
• Results First Posted: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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

Locations

ES (34)