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

NCT07141771 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-26

No results posted yet for this study

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.

Conditions

  • SCLC, Extensive Stage

Interventions

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

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2030-06-30
Completion
2030-12-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07141771 on ClinicalTrials.gov