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

Conditions

• SCLC, Extensive Stage

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Dec 31, 2025

Status verified

Jul 2025

Primary completion

Jun 30, 2030

Completion

Dec 31, 2030

Study Design

Enrollment

100 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: N subtype
  N subtype
• Experimental: subtype P and subtype A with low BCL-2 expression
  subtype P and subtype A with low BCL-2 expression
• Experimental: subtype Y
  subtype Y
• Experimental: low expression in SLFN11
  low expression in SLFN11
• Experimental: high expression in SLFN11
  high expression in SLFN11

Primary Outcome Measure

ORR [ Time Frame: each cycle is 21 or28 days,from the first use until the date of first documented progression or date of death from any cause or start new anti-tumor therapy or withdraw ICF or the study is over，whichever came first, assessed up to 24 months ]