Surufatinib plus toripalimab combined with etoposide and cisplatin as first-line treatment in advanced small-cell lung cancer patients: a phase Ib/II trial.
Yaxiong Zhang, Yan Huang, Yunpeng Yang...
https://pubmed.ncbi.nlm.nih.gov/39327433Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID07086456
Evaluating the Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer: A Prospective, Single-Arm Phase II Clinical Trial
Led by Sun Yat-sen University · Updated on 2025-07-25
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining surufatinib and tislelizumab with concurrent chemoradiotherapy in patients who have unresectable, locally advanced stage III non-small cell lung cancer (NSCLC). This phase II clinical trial aims to explore how this combination treatment, followed by consolidation therapy, may impact disease progression and survival outcomes for these patients. All participants will first receive concurrent chemoradiotherapy along with surufatinib and tislelizumab. Surufatinib is taken orally at 200 mg once daily for two weeks followed by a one-week break, forming a 21-day treatment cycle. Tislelizumab is given via intravenous infusion at 200 mg every three weeks, continuing for up to 12 months. Patients who show complete response, partial response, or stable disease after this initial treatment phase will continue with consolidation therapy using surufatinib and tislelizumab. During the study, participants will undergo assessments including tumor response evaluations, survival monitoring, and quality of life questionnaires. Researchers will also track treatment-related side effects and changes in minimal residual disease over time. The main outcome measured is the progression-free survival rate at two years. The study will follow participants for up to two years to gather comprehensive data on treatment effects and safety.
CONDITIONS
Brief Title
Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 75 years
- Histologically or cytologically confirmed locally advanced, unresectable non-small cell lung cancer (Stage IIIA-IIIC)
- Adequate archival, unstained tumor tissue samples available for analysis
- Expected life expectancy of at least 12 weeks
- WHO performance status score of 0 or 1
- Postmenopausal women, or negative pregnancy test within 14 days before study treatment
- Female participants must not be breastfeeding
- Women of childbearing potential and sexually active male participants must agree to use effective contraception during treatment and for 6 months after
- Adequate organ and bone marrow function based on specified laboratory criteria
You will not qualify if you...
- Participation in another clinical study, except observational studies
- Histological diagnosis of combined small cell and non-small cell lung cancer
- Presence of EGFR or ALK driver gene mutations
- Conditions affecting oral medication intake (e.g., dysphagia, chronic diarrhea, bowel obstruction)
- Major surgery within 4 weeks before study entry (excluding vascular access)
- QTc interval of 470 ms or more
- Uncontrolled comorbidities such as active infections, heart failure, hypertension, angina, arrhythmias, bleeding disorders, or certain viral infections
- Psychiatric or social conditions interfering with study compliance or consent
- History of another primary cancer within 5 years, except certain skin or cervical cancers
- Pregnant or breastfeeding women; or those not using effective contraception
- Use of immunosuppressive medications within 28 days prior to first dose of tislelizumab, with some exceptions
- History or active autoimmune disease within 2 years
- History of inflammatory bowel disease or primary immunodeficiency
- History of organ transplantation requiring immunosuppressive therapy
- Live attenuated vaccine within 30 days before or after starting study
- Any condition that may interfere with study treatment assessment as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Concurrent chemoradiotherapy duration plus up to 12 months of consolidation therapy
Participants receive definitive concurrent chemoradiotherapy combined with surufatinib and tislelizumab. Surufatinib is taken orally for 14 consecutive days followed by a 1-week break in each 21-day cycle. Tislelizumab is administered intravenously every 3 weeks. Concurrent chemotherapy with albumin-bound paclitaxel and cisplatin is given weekly, alongside hypofractionated radiotherapy.
Weekly visits during chemoradiotherapy and then visits every 3 weeks during consolidation therapy
Trial Site Locations
Total: 1 location
1
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
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Research Team
B
Bo Qiu
H
Hui Liu, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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