Actively Recruiting
Safety and Efficacy Evaluation of Serplulimab Plus Chemo in SCLC Transformed From EGFR-mutated NSCLC After Treatment
Led by Guangdong Association of Clinical Trials · Updated on 2026-05-06
66
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
Sponsors
G
Guangdong Association of Clinical Trials
Lead Sponsor
G
Guangdong Provincial People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy Evaluation of Serplulimab Plus Chemo in SCLC Transformed From EGFR-mutated NSCLC After Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers willing to participate in the clinical study
- Age between 18 and 75 years inclusive at the time of consent
- Pathology and genetic testing confirming NSCLC with EGFR mutations before transformation
- Pathology confirming transformation to SCLC, high-grade neuroendocrine carcinoma, or containing SCLC components
- No systemic therapy or anti-PD-1/L1 and CTLA-4 therapy after transformation; prior immunotherapy before transformation allowed if last therapy did not include immunotherapy
- Previous anti-tumor treatment ended more than 2 weeks before first study medication, with adverse events recovered to grade 1 or less (except grade 2 alopecia)
- At least one measurable lesion per RECIST v1.1 within 4 weeks before first dose
- ECOG performance status 0 or 1
- Expected life expectancy of at least 12 weeks
- Adequate organ function
- Negative pregnancy test within 14 days before treatment for female patients, with effective contraception during and up to 6 months after treatment; lactation prohibited during treatment
- Male patients agree to abstinence or contraception during study
You will not qualify if you...
- Unable to provide pathology report after tissue transformation
- History of severe allergies to monoclonal antibodies (grade greater than 3) or hypersensitivity to carboplatin or etoposide
- Active CNS metastases or cancerous meningitis (except stable or asymptomatic brain metastases treated at least 4 weeks prior)
- Received systemic therapy or immune checkpoint inhibitors after transformation; history or preparation for organ or bone marrow transplant
- Active infection requiring systemic treatment within 14 days before first dose
- Recent myocardial infarction or poorly controlled arrhythmia within 6 months; severe cardiac insufficiency or low left ventricular ejection fraction; significant pleural, pericardial effusion or ascites needing intervention
- Uncontrolled hypercalcemia, poor blood pressure control, deep vein thrombosis or bleeding history related to anti-angiogenic drugs
- Active or suspected autoimmune diseases requiring systemic immunosuppression (stable autoimmune disease without immunosuppression allowed)
- Conditions interfering with lung toxicity detection or unsuitable for trial participation as judged by investigator
- Hepatitis B or C infection, positive syphilis or HIV tests, history of mental drug abuse
- Other active malignancies within 5 years or concurrent cancers
- Vaccination with live or attenuated vaccines within 28 days before first dose or planned during study (except inactivated influenza vaccine)
- Major surgery planned or recent
- Untreated spinal cord compression or recent radical radiotherapy within 3 months
- Participation in other clinical trials with interventions within 3 months or 5 half-lives before screening
AI-Screening
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Trial Site Locations
Total: 1 location
1
Guangdong Provincial Perople's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
J
Jie Huang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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