Menu
Not yet recruiting NCT06375109

PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage SCLC

Phase II Interventional Limited-stage Small-cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tislelizumab, Carboplatin injection, Cisplatin injection, Etoposide injection.
Who it may be relevant to
Registry conditions: Limited-stage Small-cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage Small Cell Lung Cancer: an Open-label, Non-randomized Controlled, Phase II, Single-center Study

Overview

This is an open-label, non-randomized, controlled, single-center, phase II study to compare the efficacy and safety of neoadjuvant PD-L1/PD-1 inhibitor + chemotherapy (carboplatin/cisplatin + etoposide) with chemotherapy (carboplatin/cisplatin + etoposide) alone followed by radical surgery and adjuvant treatment as perioperative therapy in patients with limited-stage SCLC.

Interventions

  • Drug Tislelizumab
    administered via Intravenous (IV) injection
  • Drug Carboplatin injection
    administered via IV injection
  • Drug Cisplatin injection
    administered via IV injection
  • Drug Etoposide injection
    administered via IV injection

Primary outcome measures

  • Pathologic Complete Response (pCR) Rate [Time frame: Up to 3 months following completion of neoadjuvant treatment]
Secondary outcome measures (5)
  • Major Pathologic Response (MPR) Rate [Time frame: Up to 3 months following completion of neoadjuvant treatment]
  • Event-Free Survival (EFS) [Time frame: up to 5 years]
  • Overall Survival (OS) [Time frame: up to 5 years]
  • Objective response rate (ORR) [Time frame: Up to 1 months following completion of neoadjuvant treatment]
  • Safety: frequency of severe adverse events [Time frame: up to 6 months]

Eligibility criteria

Inclusion criteria

  • Patients voluntarily participated in this study, signed an informed consent form, and demonstrated good compliance.
  • They were histologically or cytologically confirmed with limited-stage small-cell lung cancer (TNM stage; T1-3N0-2M0).
  • The age range was 18 to 75 years, with no gender restriction.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0-2.
  • Life expectancy was estimated to be at least 3 months.
  • No previous anti-tumor treatment specifically for SCLC was administered.
  • According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, there must be at least one measurable lesion.
  • Patients' organ functions must be adequately sufficient, with the following requirements to be met before the first study treatment:
  • Hematological parameters: ANC ≥1.5×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥90g/L.
  • Renal function: serum creatinine ≤1.5 times the upper limit, or creatinine clearance ≥50 mL/min.
  • Liver function: ALT/AST ≤2.5 times the upper limit, total serum bilirubin ≤2 times the upper limit.
  • Coagulation: INR should be ≤ 1.5 times the upper limit.
  • Patients of childbearing potential must agree to use contraception.
  • Patients must be able to tolerate chemotherapy, immunotherapy, and surgery.

Exclusion criteria

  • Patients who have received anti-tumor treatment for SCLC (including but not limited to chemotherapy and radiation therapy at the site of the lesion).
  • Patients who have previously used immune checkpoint inhibitors such as PD-1/PD-L1 inhibitors for treatment.
  • Patients with a history of interstitial lung disease, non-infectious pneumonia, or uncontrollable systemic diseases, including pulmonary fibrosis and acute lung disease.
  • Patients requiring systemic anti-bacterial, anti-fungal, or anti-viral treatment for severe chronic or active infections, including tuberculosis.
  • Patients known to have HIV.
  • Patients with active hepatitis B or hepatitis C.
  • Patients with active autoimmune diseases or a history of autoimmune diseases that may recur.
  • Patients with diseases requiring systemic corticosteroid treatment or other immunosuppressive therapy.
  • Patients deemed by the investigator to have concomitant diseases that pose a serious risk to patient safety or could affect the patient's ability to complete the study.
  • Patients who have undergone major surgery within 4 weeks prior to treatment initiation, or those with significant trauma or fractures, or those with unhealed wounds at the time of treatment.
  • Patients with severe cardiac diseases, such as NYHA class III or higher congestive heart failure, CCS class III or higher angina, a history of myocardial infarction in the past 6 months, or arrhythmias requiring medication.
  • Patients with comorbidities that make them unsuitable for surgery.
  • Patients who have had an allergic reaction to the study drug or excipients in the medication.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06375109 · BJXK-2023-KY-53 · NeoSCLC-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗