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

Phase 2

Not yet recruiting

• Conditions: Limited-stage Small-cell Lung Cancer
• Interventions: Drug: Tislelizumab; Drug: Cisplatin injection; Drug: Carboplatin injection; Drug: Etoposide injection

• Registration Number: NCT06375109
• Lead Sponsor: Beijing Chest Hospital, Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-16
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-17
• Last Update Submitted: 2024-04-17
• Study First Posted: 2024-04-19
• Last Update Posted: 2024-04-19
• Primary Completion: 2027-04-15
• Study Completion: 2029-04-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients voluntarily participated in this study, signed an informed consent form, and demonstrated good compliance.

2. They were histologically or cytologically confirmed with limited-stage small-cell lung cancer (TNM stage; T1-3N0-2M0).

3. The age range was 18 to 75 years, with no gender restriction.

4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0-2.

5. Life expectancy was estimated to be at least 3 months.

6. No previous anti-tumor treatment specifically for SCLC was administered.

7. According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, there must be at least one measurable lesion.

8. Patients' organ functions must be adequately sufficient, with the following requirements to be met before the first study treatment:

   1. Hematological parameters: ANC ≥1.5×10^9/L, platelets ≥100×10^9/L, hemoglobin ≥90g/L.
   2. Renal function: serum creatinine ≤1.5 times the upper limit, or creatinine clearance ≥50 mL/min.
   3. Liver function: ALT/AST ≤2.5 times the upper limit, total serum bilirubin ≤2 times the upper limit.
   4. Coagulation: INR should be ≤ 1.5 times the upper limit.

9. Patients of childbearing potential must agree to use contraception.

10. Patients must be able to tolerate chemotherapy, immunotherapy, and surgery.

Exclusion Criteria

1. Patients who have received anti-tumor treatment for SCLC (including but not limited to chemotherapy and radiation therapy at the site of the lesion).
2. Patients who have previously used immune checkpoint inhibitors such as PD-1/PD-L1 inhibitors for treatment.
3. Patients with a history of interstitial lung disease, non-infectious pneumonia, or uncontrollable systemic diseases, including pulmonary fibrosis and acute lung disease.
4. Patients requiring systemic anti-bacterial, anti-fungal, or anti-viral treatment for severe chronic or active infections, including tuberculosis.
5. Patients known to have HIV.
6. Patients with active hepatitis B or hepatitis C.
7. Patients with active autoimmune diseases or a history of autoimmune diseases that may recur.
8. Patients with diseases requiring systemic corticosteroid treatment or other immunosuppressive therapy.
9. 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.
10. 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.
11. 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.
12. Patients with comorbidities that make them unsuitable for surgery.
13. Patients who have had an allergic reaction to the study drug or excipients in the medication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
neoCT	Cisplatin injection	Neoadjuvant chemotherapy (2-3 cycles), Adjuvant chemotherapy (1-2 cycles)
neoCIT	Etoposide injection	Neoadjuvant chemotherapy + Tislelizumab(2-3 cycles), Adjuvant chemotherapy + Tislelizumab (1-2 cycles), Maintenance Tislelizumab
neoCIT	Carboplatin injection	Neoadjuvant chemotherapy + Tislelizumab(2-3 cycles), Adjuvant chemotherapy + Tislelizumab (1-2 cycles), Maintenance Tislelizumab
neoCIT	Cisplatin injection	Neoadjuvant chemotherapy + Tislelizumab(2-3 cycles), Adjuvant chemotherapy + Tislelizumab (1-2 cycles), Maintenance Tislelizumab
neoCT	Carboplatin injection	Neoadjuvant chemotherapy (2-3 cycles), Adjuvant chemotherapy (1-2 cycles)
neoCIT	Tislelizumab	Neoadjuvant chemotherapy + Tislelizumab(2-3 cycles), Adjuvant chemotherapy + Tislelizumab (1-2 cycles), Maintenance Tislelizumab
neoCT	Etoposide injection	Neoadjuvant chemotherapy (2-3 cycles), Adjuvant chemotherapy (1-2 cycles)

Primary Outcome Measures

Name	Time	Method
Pathologic Complete Response (pCR) Rate	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 Outcome Measures

Name	Time	Method
Safety: frequency of severe adverse events	up to 6 months	The frequency of severe adverse events from the participants enrolling to 90 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
Overall Survival (OS)	up to 5 years	OS is defined as the time from enrollment until death from any cause.
Major Pathologic Response (MPR) Rate	Up to 3 months following completion of neoadjuvant treatment	MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes in neoadjuvant therapy.
Event-Free Survival (EFS)	up to 5 years	EFS is defined as the time from enrollment until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause.
Objective response rate (ORR)	Up to 1 months following completion of neoadjuvant treatment	The proportion of patients who have had a complete response or partial response (according to RECIST1.1) in all patients who have completed the neoadjuvant therapy.; Only patients with measurable lesions at baseline will be analyzed.