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
- Phase
- Phase 2
- Intervention
- Tislelizumab
- Conditions
- Limited-stage Small-cell Lung Cancer
- Sponsor
- Beijing Chest Hospital, Capital Medical University
- Enrollment
- 60
- Primary Endpoint
- Pathologic Complete Response (pCR) Rate
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Liang Shi, MD
MD，Associate Chief Physician
Beijing Chest Hospital, Capital Medical University
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-
- •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.
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.
Arms & Interventions
neoCIT
Neoadjuvant chemotherapy + Tislelizumab(2-3 cycles), Adjuvant chemotherapy + Tislelizumab (1-2 cycles), Maintenance Tislelizumab
Intervention: Tislelizumab
neoCIT
Neoadjuvant chemotherapy + Tislelizumab(2-3 cycles), Adjuvant chemotherapy + Tislelizumab (1-2 cycles), Maintenance Tislelizumab
Intervention: Carboplatin injection
neoCIT
Neoadjuvant chemotherapy + Tislelizumab(2-3 cycles), Adjuvant chemotherapy + Tislelizumab (1-2 cycles), Maintenance Tislelizumab
Intervention: Cisplatin injection
neoCIT
Neoadjuvant chemotherapy + Tislelizumab(2-3 cycles), Adjuvant chemotherapy + Tislelizumab (1-2 cycles), Maintenance Tislelizumab
Intervention: Etoposide injection
neoCT
Neoadjuvant chemotherapy (2-3 cycles), Adjuvant chemotherapy (1-2 cycles)
Intervention: Carboplatin injection
neoCT
Neoadjuvant chemotherapy (2-3 cycles), Adjuvant chemotherapy (1-2 cycles)
Intervention: Cisplatin injection
neoCT
Neoadjuvant chemotherapy (2-3 cycles), Adjuvant chemotherapy (1-2 cycles)
Intervention: Etoposide injection
Outcomes
Primary Outcomes
Pathologic Complete Response (pCR) Rate
Time Frame: Up to 3 months following completion of neoadjuvant treatment
pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Secondary Outcomes
- Safety: frequency of severe adverse events(up to 6 months)
- Overall Survival (OS)(up to 5 years)
- Major Pathologic Response (MPR) Rate(Up to 3 months following completion of neoadjuvant treatment)
- Event-Free Survival (EFS)(up to 5 years)
- Objective response rate (ORR)(Up to 1 months following completion of neoadjuvant treatment)