NCT07141771

An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Small-cell lung cancer (SCLC) has a high degree of malignancy and extremely poor prognosis, slow progress in the treatment of ES-SCLC, and a more ideal posterior therapy needs to be explored. This is an I / II, phase umbrella study to explore afterline treatment options following progression of frontline platinum-containing therapy for small cell lung cancer. This study includes 2 parts: Part 1 will enroll patients with end of first-line platinum-containing therapy and progression interval of less than 180 days or more of second-line therapy (no first-line relapse time required). Part 2 will enroll patients with end of first-line platinum-containing therapy greater than 180 days. Based on the optimal selection of patients with recurrent broad-stage small cell lung cancer with different molecular and clinical characteristics, we further explored different treatment modes suitable for different populations through umbrella cohort studies.

Detailed description

Small-cell lung cancer (SCLC) has a high degree of malignancy and extremely poor prognosis, slow progress in the treatment of ES-SCLC, and a more ideal posterior therapy needs to be explored. This is an I / II, phase umbrella study to explore afterline treatment options following progression of frontline platinum-containing therapy for small cell lung cancer. This study includes 2 parts: Part 1 will enroll patients with end of first-line platinum-containing therapy and progression interval of less than 180 days or more of second-line therapy (no first-line relapse time required). Cohort 1 patients enrolled with N subtype were given either Serplulimab plus second-line chemotherapy or other treatment as assessed by the physician; cohort 2 patients enrolled with subtype P and subtype A with low BCL-2 expression were given Fluzoparib with Temozolomide ; cohort 3 patients enrolled with subtype Y received Serplulimab plus second-line chemotherapy ; Part 2 will enroll patients with end of first-line platinum-containing therapy greater than 180 days. Cohort 4 patients with low expression in SLFN11 were given Serplulimab plus first-line chemotherapy ; cohort 5 patients with high SLFN11 expression were given Serplulimab plus Lurbinectedin. Based on the optimal selection of patients with recurrent broad-stage small cell lung cancer with different molecular and clinical characteristics, we further explored different treatment modes suitable for different populations through umbrella cohort studies, which is of great significance to prolong the survival of patients.

Conditions

• SCLC, Extensive Stage

Interventions

Type	Name	Description
DRUG	Serplulimab	Serplulimab: 4.5mg/kg, ivgtt, 21 days/cycle
DRUG	Fluzoparib	100mg BID oral
DRUG	Topotecan/Irinotecan/Paclitaxel/Temozolomide	second-line chemotherapy options: Topotecan/Irinotecan/Paclitaxel/Temozolomide etc.
DRUG	Etoposide/Carboplatin/Cisplatin	First-line chemotherapy: the original first-line chemotherapy regimen, recommended Etoposide 100mg / m2 d1-3, Carboplatin AUC = 5 d1 / Cisplatin 75mg / m2 d1 q21d
DRUG	Lurbinectedin	2.6mg/m2 (3 patients, if safe, in the 3.2mg / m2 dose group) or 3.2 mg / m2, ivgttd,21d / cycle .
DRUG	Temozolomide	150mg/m2, oral, on days 1-5,28d / cycle

Timeline

• Start date: 2025-12-31
• Primary completion: 2030-06-30
• Completion: 2030-12-31
• First posted: 2025-08-26
• Last updated: 2025-08-26