Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer
NCT ID: NCT06719700
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
47 participants
INTERVENTIONAL
2024-11-30
2028-11-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
The study group
In this single-arm, patients are planned to receive four cycles of etoposide combined with either cisplatin or carboplatin, along with toripalimab and surufatinib. During chemotherapy, patients will undergo concurrent radiotherapy. Following chemoradiotherapy, consolidation treatment with toripalimab and surufatinib will be administered. Prophylactic cranial irradiation (PCI) is recommended prior to the initiation of immunotherapy consolidation.
Chemotherapy
Etoposide combined with cisplatin or carboplatin, administered every three weeks for a total of four cycles.
Immunotherapy
Toripalimab was administered concurrently with chemotherapy, every three weeks for four cycles.
Angio-immuno kinase inhibitor
Oral surufatinib 200 mg once daily (q.d.), given on days 1-14 of each chemotherapy cycle.
radiotherapy
Thoracic radiotherapy will begin no later than the start of the third chemotherapy cycle.
Prophylactic Cranial Irradiation
PCI is recommended after the completion of chemoradiotherapy.
Consolidation Therapy with Toripalimab and Surufatinib
Patients achieving complete response (CR), partial response (PR), or stable disease (SD) following chemoradiotherapy will receive consolidation therapy. Toripalimab: 240 mg intravenously on day 1, every three weeks. Surufatinib: 200 mg orally on days 1-14, every three weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Chemotherapy
Etoposide combined with cisplatin or carboplatin, administered every three weeks for a total of four cycles.
Immunotherapy
Toripalimab was administered concurrently with chemotherapy, every three weeks for four cycles.
Angio-immuno kinase inhibitor
Oral surufatinib 200 mg once daily (q.d.), given on days 1-14 of each chemotherapy cycle.
radiotherapy
Thoracic radiotherapy will begin no later than the start of the third chemotherapy cycle.
Prophylactic Cranial Irradiation
PCI is recommended after the completion of chemoradiotherapy.
Consolidation Therapy with Toripalimab and Surufatinib
Patients achieving complete response (CR), partial response (PR), or stable disease (SD) following chemoradiotherapy will receive consolidation therapy. Toripalimab: 240 mg intravenously on day 1, every three weeks. Surufatinib: 200 mg orally on days 1-14, every three weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age: Males or females aged 18 to 75 years.
* Diagnosis: Histologically or cytologically confirmed small cell lung cancer (SCLC).
* Stage: Stage I-III (AJCC/UICC 8th edition TNM staging), where all lesions can be included in a single radical radiotherapy plan (i.e., limited-stage disease). Stage I-II must be inoperable.
* Life Expectancy: ≥12 weeks.
* Performance Status (PS): WHO PS score of 0 or 1.
* Postmenopausal women or those with a negative urine or serum pregnancy test (HCG sensitivity ≥25 IU/L or equivalent) within 7 days before starting study treatment.
* Female participants must not be breastfeeding.
* Women of childbearing potential (WOCBP) must agree to use contraception during study treatment and for 3 months after the last dose of study drug (i.e., 30 days for an ovulation cycle plus approximately 5 half-lives of the investigational drug).
* Male participants engaging in sexual activity with WOCBP must agree to use contraception during study treatment and for 5 months after the last dose of study drug (i.e., 90 days for sperm regeneration cycle plus approximately 5 half-lives of the investigational drug).
* Males with azoospermia do not need to follow contraception requirements.
* WOCBP who are not sexually active do not need to follow contraception requirements but must still undergo pregnancy testing as outlined.
* Organ and Bone Marrow Function:
Pulmonary Function: FEV1 ≥800 mL. Absolute neutrophil count ≥1.5 × 10⁹/L. Platelet count ≥100 × 10⁹/L. Hemoglobin ≥9.0 g/dL. Renal Function: Calculated creatinine clearance ≥50 mL/min using the Cockcroft-Gault formula.
Serum bilirubin ≤1.5 × upper limit of normal (ULN). AST and ALT ≤2.5 × ULN.
Exclusion Criteria
* Mixed Histology: Histological subtype of mixed small cell and non-small cell lung cancer (SCLC).
* Extensive-Stage SCLC: Diagnosis of extensive-stage SCLC.
* Malignant Effusions: Pathologically confirmed malignant pleural effusion or pericardial effusion.
* Hemoptysis: Central cavitary SCLC with hemoptysis (hemoptysis volume \>50 ml/day).
* Immunosuppressive Treatment: Use of immunosuppressive drugs within 28 days prior to the first dose of toripalimab. Physiological doses of intranasal corticosteroids and systemic corticosteroids ≤10 mg daily of prednisone (or equivalent) are exceptions. Steroids used to manage chemoradiotherapy-related toxicities are allowed.
* Previous Anti-PD-1/PD-L1 Therapy: Prior use of any anti-PD-1 or anti-PD-L1 antibodies.
* Major Surgery: Underwent major surgery (excluding vascular access) within 4 weeks before study entry.
* Autoimmune Disease History: History of autoimmune diseases within the last 2 years, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis.
* Primary Immunodeficiency: History of primary immunodeficiency.
* Organ Transplant History: History of organ transplantation requiring immunosuppressive treatment.
* QT Interval Prolongation: QTc interval (corrected by Bazett's formula) \>470 ms, calculated from three ECG measurements.
* Uncontrolled Comorbidities: Uncontrolled comorbid conditions, including but not limited to persistent or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmias, active peptic ulcer disease or gastritis, active bleeding disorders, chronic hepatitis C, HIV infection, HBsAg-positive patients with DNA \>500 IU/ml, or any psychiatric or social conditions that may interfere with study requirements or the patient's ability to provide informed consent.
* Tuberculosis History: Known history of tuberculosis.
* Live Vaccination: Received a live attenuated vaccine within 30 days prior to study initiation.
* Previous Primary Malignancy: History of another primary malignancy within 5 years prior to study entry, except for adequately treated basal or squamous cell carcinoma of the skin, in situ cervical cancer, ductal carcinoma in situ of the breast, or localized prostate cancer.
* Pregnancy and Breastfeeding: Pregnant or breastfeeding women, or men and women of reproductive potential who are not using effective contraception.
* Interference with Study Assessment: Any condition that may interfere with the evaluation of toripalimab's efficacy or safety.
* Investigator's Discretion: Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Yat-sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hui Liu
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hui Liu, Professor
Role: PRINCIPAL_INVESTIGATOR
Sun yat-sen universtiy cancer center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Hui Liu, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Zhang Y, Huang Y, Yang Y, Zhao Y, Zhou T, Chen G, Zhao S, Zhou H, Ma Y, Hong S, Zhao H, Zhang L, Fang W. Surufatinib plus toripalimab combined with etoposide and cisplatin as first-line treatment in advanced small-cell lung cancer patients: a phase Ib/II trial. Signal Transduct Target Ther. 2024 Sep 27;9(1):255. doi: 10.1038/s41392-024-01974-2.
Li, X. et al. Enhanced anticancer efficacy via ROS-dependent ferroptosis: Synergy between surufatinib and cisplatin in small cell lung cancer. Cancer Res 84(6_Supplement), 2122 (2024)
Zhou, J. et al. Preclinical evaluation of sulfatinib, a novel angio-immuno kinase inhibitor targeting VEGFR, FGFR-1 and CSF-1R kinases. AACR 77, abs 4187 (2017)
David R. Spigel et al., ADRIATIC: Durvalumab (D) as consolidation treatment (tx) for patients (pts) with limited-stage small-cell lung cancer (LS-SCLC). JCO 42, LBA5-LBA5(2024).
Senan S, Okamoto I, Lee GW, Chen Y, Niho S, Mak G, Yao W, Shire N, Jiang H, Cho BC. 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. Clin Lung Cancer. 2020 Mar;21(2):e84-e88. doi: 10.1016/j.cllc.2019.12.006. Epub 2019 Dec 28.
Takada M, Fukuoka M, Kawahara M, Sugiura T, Yokoyama A, Yokota S, Nishiwaki Y, Watanabe K, Noda K, Tamura T, Fukuda H, Saijo N. Phase 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. J Clin Oncol. 2002 Jul 15;20(14):3054-60. doi: 10.1200/JCO.2002.12.071.
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GASTO-10123
Identifier Type: -
Identifier Source: org_study_id