Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer

NCT06121505 · tracked via the Priya Life Science China tracker

Sponsor

Sichuan University

Phase

Phase 2

Started

2024-03-01

Last updated

2025-12-17

Condition(s) studied

Lung Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

low-dose radiation therapy and stereotactic body radiation therapychemotherapySintilimab →

low-dose radiation therapy and stereotactic body radiation therapy: Patients will receive radiation therapy.

chemotherapy: Patients will receive sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles. Patients subsequently received maintenance treatment with sintilimab, and continued treatment until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other circumstances that should stop treatment as specified in the protocol. Whichever occurs first. The maximum treatment time with sintilimab is 24 months (or 35 cycles).

Sintilimab: Patients will receive sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles. Patients subsequently received maintenance treatment with sintilimab, and continued treatment until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other circumstances that should stop treatment as specified in the protocol. Whichever occurs first. The maximum treatment time with sintilimab is 24 months (or 35 cycles).

Study summary

This is a randomized, controlled, open-label, multicenter phase II clinical trial comparing the efficacy and safety of low-dose radiation therapy and stereotactic body radiation therapy combined with PD-1 inhibitor (sintilimab) and standard platinum-based doublet chemotherapy versus PD-1 inhibitor (sintilimab) combined with standard platinum-based doublet chemotherapy as first-line treatment in patients with locally advanced or metastatic squamous cell lung cancer.

There will be 57 subjects in the experimental group and 57 subjects in the control group, with a total of 114 subjects.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Age ≥ 18 years old and ≤ 75 years old; 2. Histologically or cytologically confirmed squamous cell lung cancer, imaging confirmed locally advanced or metastatic disease (unresectable or not eligible for definitive chemoradiotherapy, stage IIIB-IV); 3. According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one imaging measurable lesion; 4. Enough to provide quality control qualified tumor tissue or cell wax blocks to detect PD-L1 expression; 5. Have not received any systemic anti-tumor treatment for locally advanced or metastatic disease in the past; Exclusion Criteria: 1. The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and non-small cell lung cancer (NSCLC)； 2. The pathology is lung adenocarcinoma, including lung cancer mixed with lung adenocarcinoma and lung squamous cell carcinoma; 3. EGFR gene sensitive mutation or ALK fusion positive or ROS1 fusion positive; 4. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors; 5. Pregnant or lactating women;

Primary outcome measure(s)

objective response rate (ORR) — Every 6 weeks (±7 days) from the first dose of study drug, and every 12 weeks (±7 days) after 48 weeks (up to 24 months).
The proportion of subjects with complete response (CR) or partial response (PR) in the analyzed population as judged by the investigator according to RECIST v1.1 criteria. ORR = (number of subjects with CR + PR) / total number of subjects \* 100%.

Trial sites (6)

Facility	City	Region	Status
The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing Municipality	Recruiting
Guizhou Provincial People's Hospital	Guiyang	Guizhou	Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hunan	Recruiting
Sichuan Cancer Hospital	Chengdu	Sichuan	Recruiting
West China Hospital of Sichuan University	Chengdu	Sichuan	Recruiting
Affiliated Hospital of North Sichuan Medical College	Nanchong	Sichuan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06121505 on ClinicalTrials.gov ↗ ← All trials in China