Durvalumab as Consolidation Therapy in Patients With LS-SCLC Following sCRT
Recruiting · NCT07309211 · Observational (researchers observe without assigning treatment) · Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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.
Where it is running
4 locations listed.
- Cancer Hospital of Shandong First Medical University - Jinan, China
- Nanjing Chest Hospital - Nanjing, China
- The First Affiliated Hospital with Nanjing Medical University - Nanjing, China
- The affiliated hospital of qingdao university - Qingdao, China