CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 66 target
Drug / intervention
Serplulimab +1 moredrug
Likely dose
Serplulimab 300mgfrom record
Key inclusion· 15
  • ✓Age 18-75 years at ICF signing
  • ✓Pathological diagnosis of EGFR-mutant NSCLC before transformation
  • ✓Pathological diagnosis of SCLC or high-grade neuroendocrine carcinoma after transformation
  • ✓No systemic therapy or checkpoint inhibitor therapy post-transformation
Key exclusion· 27
  • ✕Unable to provide pathology report after transformation
  • ✕Severe allergies to monoclonal antibodies (NCI-CTCAE grade >3)
  • ✕Known hypersensitivity to carboplatin or etoposide
  • ✕Active CNS metastases or cancerous meningitis (with exceptions for asymptomatic or stable treated brain mets)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05957510
NCT05957510Phase 2RecruitingOn Track
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Evaluation of Safety and Efficacy of Serplulimab Plus Chemotherapy in Patients With Histological Transformation From EGFR-mutated NSCLC to SCLC After Treatment: a Single-arm, Multicenter, Open-label Phase II Study

Guangdong Association of Clinical Trials·interventional·Posted Jul 24, 2023·Updated May 6, 2026

In Brief

A Phase 2 clinical trial evaluating Serplulimab and SOC for Small-cell Lung Cancer. Currently recruiting, targeting 66 participants across 1 site.

Detailed Summary

This investigator-initiated, open-label, prospective Phase II clinical trial, planned to take place across multiple centers in China. We design this trial to evaluate the safety and efficacy of Serplulimab plus chemotherapy in SCLC transformed from EGFR-mutated NSCLC after treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall-cell Lung Cancer
CountriesChina
CollaboratorsGuangdong Provincial People's Hospital

Timeline

Phase 2Recruiting
2024202520262027
First PostedJul 24, 2023
Enrollment StartJul 7, 2023
Primary CompletionJun 30, 2026
Study CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 2.9 years ago

Interventions

Serplulimabdrug

serplulimab 300mg, d1, q3w, iv. etoposide 100 mg/m2, d1-3, q3w, iv. carboplatin AUC 5 (up to 750mg), d1, q3w, iv.

SOCdrug

the treatment recommended by the investigator