PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage SCLC (NeoSCLC-001)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Limited-stage Small-cell Lung Cancer
• Intervention / Treatment: Drug: Tislelizumab; Drug: Carboplatin injection; Drug: Cisplatin injection; Drug: Etoposide injection

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Liang Shi, MD; Phone Number: +8613488787767; Email: shiliang@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: neoCIT; Neoadjuvant chemotherapy + Tislelizumab(2-3 cycles), Adjuvant chemotherapy + Tislelizumab (1-2 cycles), Maintenance Tislelizumab	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
Active Comparator: neoCT; Neoadjuvant chemotherapy (2-3 cycles), Adjuvant chemotherapy (1-2 cycles)	Drug: Carboplatin injection; administered via IV injection; Drug: Cisplatin injection; administered via IV injection; Drug: Etoposide injection; administered via IV injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologic Complete Response (pCR) Rate	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.	Up to 3 months following completion of neoadjuvant treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: frequency of severe adverse events	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.	up to 6 months
Major Pathologic Response (MPR) Rate	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.	Up to 3 months following completion of neoadjuvant treatment
Event-Free Survival (EFS)	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.	up to 5 years
Overall Survival (OS)	OS is defined as the time from enrollment until death from any cause.	up to 5 years
Objective response rate (ORR)	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.	Up to 1 months following completion of neoadjuvant treatment

Collaborators and Investigators

• Sponsor: Beijing Chest Hospital, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 16, 2024
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2029

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Carboplatin; Etoposide; Tislelizumab
• Other Study ID Numbers: BJXK-2023-KY-53; NeoSCLC-001 (Other Identifier: Beijing Chest Hospital, Capital Medical University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The researchers will consider whether IPD is available to other researchers only after the paper is published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No