Clinical trial · Interventional
Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer
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).
NCT04712903CI-TRIAL-00084380CANTABRICOcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Carcinoma Extensive Disease | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Durvalumab | Drug | Durvalumab | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Durvalumab in Combination with Platinum-Etoposide
- 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.
- interventionNames
- Drug: Durvalumab
- Drug: Cisplatin
- Drug: Etoposide
- Drug: Carboplatin
Primary outcomes (2)
- measure
- Number of Patients With Adverse Events (AEs) Grade ≥ 3
- timeFrame
- During study treatment, until disease progression (median 6 months)
- description
- Patients with AEs grade ≥ 3 acording to NCI CTCAE v5.0
- measure
- Number of Patients With Immune-mediated Adverse Events (imAE)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDPiedra A, Guinart-Cuadra A, Martinez-Recio S, Mulet M, Zamora C, Osuna-Gomez R, Canto E, Ortiz MA, Alejandre J, Barba A, Sanz-Beltran J, Serra-Lopez J, Isla D, Arriola E, Paz-Ares L, Diz-Tain MP, Moreno AL, Callejo A, Vidal S, Majem M. Baseline PD-L1 expression on circulating immune cells as a predictor of survival and immune-related adverse events in extensive-stage small-cell lung cancer patients treated with durvalumab and carboplatin-etoposide (NCT04712903 Trial). J Transl Med. 2026 Feb 28;24(1):471. doi: 10.1186/s12967-026-07896-7. PMID 41764558
- DERIVEDIsla 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