Perioperative Immunotherapy for Resectable Limited-Stage SCLC

Phase 2RecruitingNCT07109401

Fudan University37 enrolled

Overview

For limited-stage small cell lung cancer (SCLC), surgical treatment is recommended for patients with T1-2N0M0 (I-IIA) by guidelines. However, whether perioperative immunotherapy extends radical surgery to stage IIB-IIIB patients with improved survival remains elusive. This is a phase II, single-arm study to evaluate the efficacy and safety of neoadjuvant Tislelizumab + chemotherapy (Cisplatin/Carboplatin + Etoposide) followed by radical surgery and adjuvant Tislelizumab ± chemotherapy for patients with limited-stage SCLC.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Perioperative Immunotherapy Limited Stage Lung Small Cell Carcinoma Resectable Small Cell Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Able to provide written informed consent and understand and agree to comply with the study requirements and assessment schedule; 2. Aged 18-75 years at the time of signing the informed consent form; 3. Pathologically (histologically or cytologically) confirmed diagnosis of small cell lung cancer; 4. Limited-stage disease (stage IIB-IIIB according to AJCC 8th edition) assessed by bronchoscopy, PET-CT, endobronchial ultrasound (EBUS), mediastinoscopy, or percutaneous biopsy, deemed resectable with curative intent (R0 resection) by the investigator. TNM staging includes T3-4 (N0 only) or N1-2 (any T) and M0, where T4 is limited to tumors \>7 cm in diameter; Patients with tumors invading the diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, carina or having separate tumor nodules in different ipsilateral lobes are excluded. N2 is limited to single station and non-bulky. 5. No prior radiotherapy, chemotherapy, immunotherapy, surgery or other systemic treatments; 6. ECOG PS score of 0-1; 7. Expected survival must be \>3 months; 8. Adequate bone marrow reserve and organ function within 30 days prior to enrollment meeting criteria for receiving platinum-based doublet chemotherapy; 9. No contraindications for immunotherapy. Exclusion Criteria: 1. Tumor histopathology indicates non-small cell lung cancer (NSCLC); 2. Presence of clinically inactive or active brain metastases; 3. Any history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis), current ILD, or suspicion of such diseases based on imaging during screening; 4. Receiving systemic corticosteroid therapy within 14 days prior to the first dose of study drug; 5. Previous radiotherapy, chemotherapy, immunotherapy, surgery, or other systemic treatments; 6. Any active malignancy within 2 years prior to enrollment; 7. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period; 8. Uncontrolled or significant cardiovascular disease at the time of enrollment; 9. Active or previously recorded autoimmune or inflammatory diseases before enrollment; 10. History of active primary immunodeficiency disorders; 11. Presence of active infections; 12. Active bleeding disorders within ≤6 months prior to administration of the study drug, including gastrointestinal bleeding evidenced by hematemesis, severe hemoptysis, or melena; 13. Non-healing wounds, active peptic ulcers, or fractures; 14. Any condition that the investigator deems makes the patient unsuitable for participation in the study.

Outcomes

Primary Outcomes

One-year Event-free Survival Rate (1-year EFS Rate)

The proportion of patients who have not experienced an EFS event within 1 year after the first administration of the study drug. EFS (Event-Free Survival) is defined as the time from the first dose of study treatment until the first occurrence of any of the following events: objectively documented disease progression and inability to undergo radical surgery, local recurrence, distant metastasis, or death from any cause (whichever occurs first). EFS is assessed by investigators based on RECIST v1.1 (Response evaluation criteria in solid tumors v1.1) criteria within the radical curative therapy analysis set.

Time frame: Up to 12 months

Secondary Outcomes

Event-free Survival (EFS)

Event-Free Survival (EFS) - defined as the time from the first dose of study treatment until the first occurrence of any of the following events: objectively documented disease progression and inability to undergo radical surgery, local recurrence, distant metastasis, or death from any cause (whichever occurs first).

Time frame: up to 60 months

Overall Survival (OS)

Overall Survival - defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.

Time frame: up to 60 months

Objective Response Rate (ORR)

Objective Response Rate (ORR) - defined as the proportion of patients who achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as assessed by investigators according to RECIST v1.1 criteria.

Time frame: Up to 12 months

Disease Control Rate (DCR)

Disease Control Rate (DCR) - defined as the proportion of patients who achieve a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), or Stable Disease (SD), as assessed by investigators according to RECIST v1.1 criteria.

Time frame: Up to 12 months

Pathological Complete Response (pCR) Rate

Pathological Complete Response (pCR) Rate - defined as the proportion of patients who have no residual tumor in the resected primary tumor site and all resected lymph nodes after neoadjuvant therapy among those who underwent surgical resection.

Time frame: Up to 12 months

Major Pathological Response (MPR) Rate

Major Pathological Response (MPR) Rate - defined as the proportion of patients who have ≤10% residual viable tumor cells in the resected primary tumor site and all resected lymph nodes after neoadjuvant therapy among those who underwent surgical resection.

Time frame: Up to 12 months

Pathological Downstaging Rate

Pathological Downstaging Rate - defined as the proportion of patients who undergo surgical resection after neoadjuvant therapy and have a postoperative pathological stage that is lower than their baseline clinical tumor stage and/or lymph node involvement.

Time frame: Up to 12 months

R0 Resection Rate

R0 Resection Rate - defined as the proportion of patients who achieve complete tumor resection (negative margins with no residual tumor cells) among those who underwent surgical resection after neoadjuvant therapy.

Time frame: Up to 12 months

Clinical Downstaging Rate

Clinical Downstaging Rate - defined as the proportion of patients who have a reduction in tumor size and/or lymph node involvement in their clinical tumor stage after neoadjuvant therapy compared to their baseline clinical tumor stage before surgery.

Time frame: Up to 12 months

Surgical Resection Rate

Surgical Resection Rate - defined as the proportion of patients who undergo surgical resection after neoadjuvant therapy.

Time frame: Up to 12 months

Incidence of Treatment-emergent Adverse Event (TEAE) and Immune-related Adverse Event (IrAE)

The incidence of TEAE and IrAE will be assessed by monitoring adverse events (AEs) and serious adverse events (SAEs) as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, and by incorporating relevant physical examinations, electrocardiograms (ECGs), and laboratory tests as needed.

Time frame: Up to 60 months

Perioperative Immunotherapy for Resectable Limited-Stage SCLC

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts