SFRT+Tislelizumab+Platinum Chemotherapy for Unresectable Stage III NSCLC

NCT07131319 | Recruiting Phase 2

• 1 other identifier: IIT-2025-026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to understand whether spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment is effective in treating initially unresectable stage Ⅲ non-small cell lung cancer (NSCLC). It will also explore the safety of this treatment modality. The main questions it aims to answer are: Will spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment increase the surgical resection rate of patients with initially unresectable stage Ⅲ non-small cell lung cancer? What adverse reactions will patients experience when receiving spatial fractionated radiotherapy (SFRT) in combination with tislelizumab and platinum-based doublet chemotherapy given concurrently as induction treatment?

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Surgical resection rate

  The percentage of patients who underwent surgical resection after induction treatment

  At the end of the surgery

Study Arms (1)

SFRT concurrent with tislelizumab and platinum - based doublet chemotherapy

EXPERIMENTAL

SFRT concurrent with immunochemotherapy is given q3w for 3 cycles. Here are details: Radiotherapy: Select several 1 - cm - diameter spherical areas in the primary tumor's hypoxic region, 1.5 - 2 cm apart. Each area receives a single 12 - Gy high - dose radiotherapy, precisely targeting the hypoxic part to enhance the effect. Chemotherapy \& Immunotherapy: 1 - 3 days after radiotherapy, combine 200 mg of tislelizumab with platinum - based doublet chemotherapy. NSCLC chemo - drug combos vary by pathology. For adenocarcinoma, use pemetrexed (500 mg/m² d1) + carboplatin (AUC 5, d1). For other types, use albumin - bound paclitaxel (100 mg/m² d1,8) + carboplatin (AUC 5, d1).

Other: Spatially Fractionated Radiotherapy (SFRT); Drug: Tislelizumab, Carboplatin, Pemetrexed; Drug: Tislelizumab, paclitaxel, Carboplatin

Interventions

Spatially Fractionated Radiotherapy (SFRT) OTHER

Several spherical volumes (with a diameter of 1 cm) are selected within the hypoxic area of the primary tumor. The distance between each spherical volume is 1.5 - 2 cm, and a high-dose radiotherapy of 12 Gy × 1F is delivered.

SFRT concurrent with tislelizumab and platinum - based doublet chemotherapy

Tislelizumab, Carboplatin, Pemetrexed DRUG

For adenocarcinoma, pemetrexed (500 mg/m², day 1) + carboplatin (AUC 5, day 1) is used.

SFRT concurrent with tislelizumab and platinum - based doublet chemotherapy

Tislelizumab, paclitaxel, Carboplatin DRUG

For NSCLC with pathological types other than adenocarcinoma, nab-paclitaxel (100 mg/m² on day 1 and day 8) + carboplatin (AUC 5, day 1) is used.

SFRT concurrent with tislelizumab and platinum - based doublet chemotherapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC) that is deemed unresectable after discussion in the multidisciplinary team (MDT), which is classified as T3-4N1-2M0 according to the 8th edition of the American Joint Committee on Cancer (AJCC).

You may not qualify if:

• Has participated in another clinical study using research products within the past 3 weeks.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

Nanchang City, Jiangxi Province

Nanchang, Jiangxi, 330000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

tislelizumab; Carboplatin; Pemetrexed; Paclitaxel

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; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Central Study Contacts

jing cai Jing Cai

CONTACT

15270905381; cjdl879@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: August 20, 2025
• Study Start: April 21, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

CN (1)