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New treatment option for Toripalimab
Official title Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06719700
What this study is testing
What is Chemotherapy?
Chemotherapy is an investigational medicine, being studied as a potential treatment for toripalimab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Based on the preclinical rationale for combining surufatinib with immunotherapy, and the clinical efficacy observed with surufatinib in extensive-stage small cell lung cancer (ES-SCLC), the investigators hypothesize that incorporating surufatinib into the ADRIATIC regimen could further enhance survival in LS-SCLC. To evaluate this approach, the investigators plan to conduct a single-arm Phase II study to explore the safety and efficacy of concurrent chemoradiotherapy combined with toripalimab and surufatinib in treating LS-SCLC.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Informed Consent: An informed consent form, signed and dated, must be provided before any steps in the study are performed.
- 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...
- Life Expectancy: ≥12 weeks.
You likely can't join if
- Participation in Another Clinical Trial: Simultaneous participation in another clinical trial, unless it is an observational (non-treatment) study.
- 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...
See the full eligibility criteria
- Informed Consent: An informed consent form, signed and dated, must be provided before any steps in the study are performed.
- 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...
- 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...
- 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...
- Participation in Another Clinical Trial: Simultaneous participation in another clinical trial, unless it is an observational (non-treatment) study.
- 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...
- 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...
- 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...
- 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...
- 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 how well it works 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.