Phase 3
Completed N=101
Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Carcinoma Extensive Disease
Source: ClinicalTrials.gov NCT04712903 ↗
Enrolled (actual)
101
Serious AEs
56.4%
Results posted
Jan 2025
Primary outcomePrimary: Number of Patients With Adverse Events (AEs) Grade ≥ 3 — 77; 24 Participants
◆ Published Evidence
Emerging
1citation · ~1 / year
Durvalumab plus platinum-etoposide in the first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): A single-arm 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.
Linked Publications
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Durvalumab plus platinum-etoposide in the first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): A single-arm clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events (AEs) Grade ≥ 3 |
77; 24 | — |
| PRIMARY Number of Patients With Immune-mediated Adverse Events (imAE) |
38; 63 | — |
| SECONDARY Progression Free Survival (PFS). |
6.1 | — |
| SECONDARY Objetive Response Rate (ORR) |
54.5 | — |
| SECONDARY Duration of Response (DoR) |
5.6 | — |
| SECONDARY Time to Treatment Discontinuation (TTD) |
6.2 | — |
| SECONDARY Overal Survival (OS) |
9.6 | — |
| SECONDARY PFS Rate at 6 Months |
53.0 | — |
| SECONDARY PFS Rate at 12 Months |
21.0 | — |
| SECONDARY DoR Rate at 12 Months |
35.7 | — |
| SECONDARY OS Rate at 6 Months |
75.2 | — |
| SECONDARY OS Rate at 12 Months |
40.7 | — |
| SECONDARY OS Rate at 18 Months |
31.6 | — |
| SECONDARY EORTC QLQ-C30: Global Health Status Domain, Change From Baseline to End of Treatment Visit |
-6.3 | — |
| SECONDARY EORTC QLQ-C30: Physical Functioning Domain, Change From Baseline to End of Treatment Visit |
-15.0 | — |
| SECONDARY EORTC QLQ-C30: Role Functioning Domain, Change From Baseline to End of Treatment Visit |
-17.0 | — |
| SECONDARY EORTC QLQ-C30: Emotional Functioning Domain, Change From Baseline to End of Treatment Visit |
-2.3 | — |
| SECONDARY EORTC QLQ-C30: Cognitive Functioning Domain, Change From Baseline to End of Treatment Visit |
-15.0 | — |
| SECONDARY EORTC QLQ-C30: Social Functioning Domain, Change From Baseline to End of Treatment Visit |
-12.0 | — |
| SECONDARY EORTC QLQ-C30: Fatigue, Change From Baseline to End of Treatment Visit |
12.4 | — |
| SECONDARY . EORTC QLQ-C30: Pain, Change From Baseline to End of Treatment Visit |
0.2 | — |
| SECONDARY EORTC QLQ-C30: Nausea and Vomiting, Change From Baseline to End of Treatment Visit |
0.7 | — |
| SECONDARY EORTC QLQ-C30: Dyspnoea, Change From Baseline to End of Treatment Visit |
-2.4 | — |
| SECONDARY EORTC QLQ-C30: Insomnia, Change From Baseline to End of Treatment Visit |
1.0 | — |
| SECONDARY EORTC QLQ-C30: Appetite Loss, Change From Baseline to End of Treatment Visit |
-2.4 | — |
| SECONDARY EORCT QLQ-C30: Constipation, Change From Baseline to End of Treatment Visit |
6.3 | — |
| SECONDARY EORTC QLQ-C30: Diarrhoea, Change From Baseline to End of Treatment Visit |
0.0 | — |
| SECONDARY EORTC QLQ-C30: Financial Difficulties, Change From Baseline to End of Treatment Visit |
10.3 | — |
| SECONDARY EORTC QLQ-LC13: Coughing, Change From Baseline to End of Treatment Visit |
-7.8 | — |
| SECONDARY EORTC QLQ-LC13: Haemoptysis, Change From Baseline to End of Treatment Visit |
-0.5 | — |
| SECONDARY EORTC QLQ-LC13: Dyspnoea, Change From Baseline to End of Treatment Visit |
3.1 | — |
| SECONDARY EORTC QLQ-LC13: Pain in Arm or Shoulder, Change From Baseline to End of Treatment Visit |
3.3 | — |
| SECONDARY EORTC QLQ-LC13: Pain in Other Parts, Change From Baseline to End of Treatment Visit |
7.4 | — |
| SECONDARY EORTC QLQ-LC13: Sore Mouth, Change From Baseline to End of Treatment Visit |
2.3 | — |
| SECONDARY EORTC QLQ-LC13: Peripheral Neuropathy, Change From Baseline to End of Treatment Visit |
13.6 | — |
| SECONDARY EORTC QLQ-LC13: Alopecia, Change From Baseline to End of Treatment Visit |
18.1 | — |
| SECONDARY EORTC QLQ-LC13: Dysphagia, Change From Baseline to End of Treatment Visit |
2.8 | — |
| SECONDARY EORTC QLQ-LC13: Chest Pain Item Change From Baseline to End of Treatment Visit |
-1.8 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04712903) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.