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

NCT06375109 | Not Yet Recruiting Phase 2

• 2 other identifiers: BJXK-2023-KY-53NeoSCLC-001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Limited-stage Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Major Pathologic Response (MPR) Rate

  Up to 3 months following completion of neoadjuvant treatment

• Event-Free Survival (EFS)

  up to 5 years

• Overall Survival (OS)

  up to 5 years

• Objective response rate (ORR)

  Up to 1 months following completion of neoadjuvant treatment

• Safety: frequency of severe adverse events

  up to 6 months

Study Arms (2)

neoCIT

EXPERIMENTAL

Neoadjuvant chemotherapy + Tislelizumab(2-3 cycles), Adjuvant chemotherapy + Tislelizumab (1-2 cycles), Maintenance Tislelizumab

Drug: Tislelizumab; Drug: Carboplatin injection; Drug: Cisplatin injection; Drug: Etoposide injection

neoCT

ACTIVE COMPARATOR

Neoadjuvant chemotherapy (2-3 cycles), Adjuvant chemotherapy (1-2 cycles)

Drug: Carboplatin injection; Drug: Cisplatin injection; Drug: Etoposide injection

Interventions

Tislelizumab DRUG

administered via Intravenous (IV) injection

neoCIT

Carboplatin injection DRUG

administered via IV injection

neoCIT; neoCT

Cisplatin injection DRUG

administered via IV injection

neoCIT; neoCT

Etoposide injection DRUG

administered via IV injection

neoCIT; neoCT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Chest Hospital, Capital Medical University: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

tislelizumab; Carboplatin; Cisplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Central Study Contacts

Liang Shi, MD

CONTACT

+8613488787767; shiliang@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD，Associate Chief Physician

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: April 16, 2024
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2029
• Last Updated: April 19, 2024

Record last verified: 2024-04