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Study of Serplulimab Plus Chemotherapy as Neoadjuvant Therapy for Limited-stage Small Cell Lung Cancer (LS-SCLC)

ConditionSCLC, Limited Stage
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangdong Provincial People's Hospital

About this trial

This investigator-initiated, open-label, prospective Phase II clinical trial, planned to take place across multiple centers in China. We aimed to evaluate the efficacy and safety of surgical resection or chemotherapy following serplulimab plus platinum-containing dual induction therapy for stage II-IIIB (N2) LS-SCLC

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in clinical research and sign written informed consent

Male or female patients aged 18-75 years old (including the critical value)

Histologically or cytologically confirmed SCLC

Clinically diagnosed as IIB-IIIB ( N2) stage (AJCC 8th edition cancer staging)

Disqualifiers

Mixed SCLC confirmed by histology or cytology

Previously received systemic anti-tumor treatment for small cell lung cancer, including but not limited to chemotherapy, immunotherapy, and radiotherapy

Other active malignant tumors within 5 years or at the same time. Cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast, can be enrolled

Those who are planning to undergo or have received organs in the past or bone marrow transplant patients

Trial design

Design model

Single group

Treatments tested in this trial

  • 4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatin

    Drug

    After 4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatin then MDT determines surgery or radical radiotherapy

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: 4 cycles of Serplulima plus platinum-containing dual drugExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

pathological complete response rate

The proportion of residual tumor cells evaluated under the microscope by the pathologist

Time frame
Within 2 weeks after radical surgery

Secondary outcomes

1

Objective response rate

Measured according to RECIST1.1 evaluation criteria

Time frame
Once every 2 cycles(each cycle is 21 days) during the combined treatment phase
2

Event-free survival

Assess whether the lesion is operable and measure the progression of the lesion according to the RECIST1.1 assessment criteria

Time frame
Follow-up at the end of cycle 2(each cycle is 28 days), 3 to 5 weeks after the last chemotherapy, 30 days after surgery, every 3 months within two years from enrollment or until death
3

Overall survival

Lesions were measured according to RECIST1.1 evaluation criteria

Time frame
Follow-up every 3 months and every 6 months within two years from enrollment or until death

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Provincial People's Hospital

Lead sponsor

Liaoning Cancer Hospital & Institute

Collaborator

Guangzhou No.12 People's Hospital

Collaborator

Second Xiangya Hospital of Central South University

Collaborator

Source ClinicalTrials.gov
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