Durvalumab as Consolidation Therapy in Patients With LS-SCLC Following sCRT

Official title

A Multi-centre, Retrospective Study Assessing Durvalumab as Consolidation Treatment for Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC) Following by Sequential Chemoradiotherapy (sCRT)

Overview

This is a retrospective, multi-centre, single arm study to assess the safety and efficacy of receiving Durvalumab in patients with Small Cell Lung Cancer Limited Stage (LS-SCLC) who have not progressed following sequential chemoradiotherapy (sCRT) in a real-world setting. The study will enroll 25 patients. The primary endpoint of the study is the incidence of Grade 3 or 4 adverse events (AEs) within 6 months of starting Durvalumab (graded by CTCAE v.5.0). The secondary endpoints of the study include real-world progression-free survival (rwPFS, the time from the start of Durvalumab treatment to disease progression or death for any reason, which occurs first), objective response rate (ORR), duration of response (DoR) and disease control rate (DCR). sCRT is more common in Mid-Eastern Chinese clinical practice. sCRT is also recommended in guideline of Chinese Society of Clinical Oncology (CSCO) Small-cell lung cancer. However, patients treated with sCRT were not included in the ADRIATIC study. So there is lack of data on safety and efficacy of Durvalumab post sCRT. Supplement real-world evidence (RWE) clinical data of sCRT in Chinese patients is needed to enhance the status of Durvalumab as a consolidation therapy for LS-SCLC. The study will retrospectively collect cases of eligible LS-SCLC patients who received sCRT and have not progressed followed by receiving Durvalumab as consolidation therapy.

Primary outcome measures

• Incidence of Grade 3 or 4 Adverse Events (AEs) within 6 months of starting Durvalumab [graded by Common Terminology Criteria for Adverse Event (CTCAE) v.5.0] [Time frame: Within 6 months of starting Durvalumab]

Secondary outcome measures (4)

• Real world PFS (rwPFS) [Time frame: From date of the first dose of Durvalumab to date of objective disease progression or death, whichever came first, assessed up to 60 months]
• ORR (Objective response rate from starting with Durvalumab treatment) [Time frame: Up to 60 months]
• DoR (Duration of response from starting with Durvalumab treatment) [Time frame: From the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first, Up to 60 months]
• DCR (Disease control rate from staring with Durvalumab treatment) [Time frame: Up to 60 months]

Eligibility criteria

Inclusion criteria

• Aged ≥18 at initial diagnosis;
• Histological or cytological evidence of LS-SCLC (Stage I-III); Stage I-II must be medically inoperable;
• Received chemotherapy sequential with radiotherapy as first-line treatment and no progression, followed by receiving Durvalumab at least 1 dose as consolidation treatment until progression, unacceptable toxicity or for a maximum of 24 months;
• Start Durvalumab treatment within 3 months after sCRT;
• Permitted PCI;
• WHO PS 0-2 before sCRT.

Exclusion criteria

• ES-SCLC or mixed SCLC and NSCLC histology;
• Active or prior documented autoimmune or inflammatory disorders or uncontrolled intercurrent illness;
• Any unresolved toxicity (CTCAE Grade ≥ 2) from prior chemoradiotherapy; 4. Received concurrent chemoradiotherapy for LS-SCLC.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

China · 4 centers

• Cancer Hospital of Shandong First Medical University — Jinan
• Nanjing Chest Hospital — Nanjing
• The First Affiliated Hospital with Nanjing Medical University — Nanjing
• The affiliated hospital of qingdao university — Qingdao

Identifiers

NCT: NCT07309211 · 2025-SR-343.A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗