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
ID06719700
A Phase II Study of Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib for Limited-Stage Small Cell Lung Cancer
Led by Sun Yat-sen University · Updated on 2026-03-03
47
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether combining surufatinib with immunotherapy and chemoradiotherapy can improve survival for patients with limited-stage small cell lung cancer (LS-SCLC). This single-arm Phase II study explores the safety and effectiveness of adding surufatinib to the standard ADRIATIC regimen, which includes toripalimab and chemoradiotherapy, aiming to enhance treatment outcomes for LS-SCLC patients. Participants will receive four cycles of chemotherapy with etoposide combined with either cisplatin or carboplatin, alongside toripalimab and oral surufatinib taken on days 1 to 14 of each cycle. Radiotherapy to the chest begins no later than the third chemotherapy cycle. After completing chemoradiotherapy, patients who show complete response, partial response, or stable disease will continue with consolidation therapy using toripalimab and surufatinib. Prophylactic cranial irradiation is recommended before starting consolidation treatment. During the study, patients will undergo various assessments to monitor their response and safety, including tracking progression-free survival over two years as the primary outcome. Researchers will also evaluate overall survival, treatment-related side effects, and patient-reported outcomes up to one year after treatment. The total study period involves close monitoring and follow-up to assess both effectiveness and safety of the combined treatment approach.
CONDITIONS
Brief Title
Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Aged 18 to 75 years, male or female
- Histologically or cytologically confirmed small cell lung cancer
- Limited-stage disease (Stage I-III) per AJCC/UICC 8th edition TNM staging
- All lesions can be included in a single radical radiotherapy plan
- Stage I-II disease must be inoperable
- Life expectancy of at least 12 weeks
- WHO performance status score of 0 or 1
- For women: postmenopausal or negative pregnancy test within 7 days before treatment
- Female participants must not be breastfeeding
- Women of childbearing potential must use contraception during treatment and for 3 months after last dose
- Men with partners of childbearing potential must use contraception during treatment and for 5 months after last dose
- Men with azoospermia are exempt from contraception requirements
- Women not sexually active must still undergo pregnancy testing as outlined
- Adequate organ and bone marrow function including lung, blood counts, renal and liver tests as specified
You will not qualify if you...
- Participation in another clinical trial, except observational studies
- Mixed small cell and non-small cell lung cancer histology
- Diagnosis of extensive-stage small cell lung cancer
- Pathologically confirmed malignant pleural or pericardial effusion
- Central cavitary small cell lung cancer with hemoptysis exceeding 50 ml/day
- Use of immunosuppressive drugs within 28 days before starting toripalimab, except certain corticosteroids
- Prior treatment with anti-PD-1 or anti-PD-L1 antibodies
- Major surgery within 4 weeks before study entry
- History of autoimmune diseases within last 2 years
- History of primary immunodeficiency
- History of organ transplantation requiring immunosuppression
- QTc interval over 470 ms based on ECG
- Uncontrolled infections, heart failure, hypertension, angina, arrhythmias, bleeding disorders, hepatitis C, HIV, or certain psychiatric/social conditions
- Known history of tuberculosis
- Live attenuated vaccine within 30 days prior to study
- Previous primary malignancy within 5 years, except certain skin and localized cancers
- Pregnant or breastfeeding women, or those not using effective contraception
- Any condition interfering with evaluation of toripalimab efficacy or safety
- Investigator's judgment deeming patient unsuitable for participation
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 - Approximately 12 weeks (four 3-week cycles)
Participants receive four cycles of chemotherapy with etoposide combined with cisplatin or carboplatin, concurrent immunotherapy with toripalimab, oral surufatinib during chemotherapy cycles, and thoracic radiotherapy starting no later than the third chemotherapy cycle.
Visits every 3 weeks for chemotherapy and immunotherapy administration, with daily oral surufatinib on days 1-14 of each cycle and concurrent radiotherapy sessions during treatment
Prophylactic Cranial Irradiation
Duration - Duration as per clinical recommendation after chemoradiotherapy
Participants receive prophylactic cranial irradiation recommended after completion of chemoradiotherapy to reduce the risk of brain metastases.
Approximately 1 visit for PCI treatment
Consolidation Therapy
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants who achieve complete response, partial response, or stable disease after chemoradiotherapy receive consolidation therapy with toripalimab every 3 weeks and oral surufatinib for days 1-14 of each consolidation cycle.
Visits every 3 weeks for toripalimab infusion and oral surufatinib administration on days 1-14 of each cycle
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, Professor
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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Published Research Related To This Trial
Design and Rationale for a Phase III, Randomized, Placebo-controlled Trial of Durvalumab With or Without Tremelimumab After Concurrent Chemoradiotherapy for Patients With Limited-stage Small-cell Lung Cancer: The ADRIATIC Study.
Suresh Senan, Isamu Okamoto, Gyeong-Won Lee...
https://pubmed.ncbi.nlm.nih.gov/31948903Phase III study of concurrent versus sequential thoracic radiotherapy in combination with cisplatin and etoposide for limited-stage small-cell lung cancer: results of the Japan Clinical Oncology Group Study 9104.
Minoru Takada, Masahiro Fukuoka, Masaaki Kawahara...
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Freddie Bray, Jacques Ferlay, Isabelle Soerjomataram...
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