NCT07485920
Not yet recruiting
Phase 4
A Prospective, Multicenter Exploratory Clinical Study on Consolidation Therapy With Tislelizumab Combined With Nintedanib for Limited-stage Small Cell Lung Cancer
The Affiliated Hospital of Qingdao University6 sites in 1 country20 target enrollmentStarted: May 1, 2026Last updated:
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 20
- Locations
- 6
- Primary Endpoint
- progression-free survival（PFS）
Overview
Brief Summary
This study is a prospective, single-arm, multicenter, exploratory clinical trial. It aims to evaluate the efficacy and safety of tislelizumab combined with nintedanib as consolidation therapy for patients with limited-stage small cell lung cancer after concurrent chemoradiotherapy, and to explore the prognostic markers related to the therapeutic effect.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have a thorough understanding of this study and have voluntarily signed the informed consent form;
- •Age ≥ 18 years old, gender not restricted;
- •ECOG score 0-1;
- •Histologically or cytologically confirmed as limited-stage small cell lung cancer;
- •At least one measurable lesion (according to RECISTv1.1 criteria);
- •Expected survival ≥ 3 months;
- •Prophylactic cranial radiotherapy is permitted before consolidation therapy;
- •Adequate organ function reserve. The subjects must meet the following laboratory indicators: Before the sample collection during the screening period, the patient has not received blood transfusion or growth factor support treatment for ≤ 14 days and: absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90 g/L，Calculated creatinine clearance rate (CrCl) (Cockcroft-Gault formula): creatinine clearance rate ≥ 60 mL/min，Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (total bilirubin of Gilbert's syndrome patients must be \< 3 × ULN)，AST and ALT ≤ 2.5 × ULN，Patients not receiving anticoagulation treatment: international normalized ratio or activated partial thromboplastin time ≤ 1.5 × ULN，Albumin ≥ 25 g/L (2.5 g/dL).
- •Willing and able to comply with the study plan's visits, treatment plan, laboratory tests and other research procedures;
- •Pregnant women must undergo a serum pregnancy test 3 days before the first medication administration and the result must be negative. For pregnant women subjects and male subjects whose partners are pregnant women, they must agree to use effective contraceptive methods during the study and within 120 days after the last administration of the study drug.
Exclusion Criteria
- •There are patients with lung metastasis from other primary malignant tumors.
- •Patients who have previously or concurrently had other systemic malignant tumors (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and/or in situ cancer that has undergone radical resection), excluding those with cured skin basal cell carcinoma, skin squamous cell carcinoma, and/or in situ cancer that has undergone radical resection.
- •Patients who have previously received other systemic treatments for the current lung cancer, including chemotherapy, immunotherapy, targeted therapy, or anti-angiogenic therapy, other than induction radiotherapy and chemotherapy.
- •Patients who received other approved systemic immunomodulators (including but not limited to interferon, interleukin-2, tumor necrosis factor, thymus pentapeptide, and thymalfasin) within 4 weeks prior to the first administration.
- •Patients whose blood pressure control is not satisfactory after drug treatment (systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg).
- •Patients with factors that significantly affect the absorption of oral medications, such as inability to swallow, chronic diarrhea, and intestinal obstruction, etc.
- •The investigator judges that the possibility of tumor invasion of important blood vessels and fatal bleeding caused by the tumor is relatively high during the treatment process.
- •Within 3 months before the study, there was significant clinical hemoptysis (more than 50 ml of hemoptysis per day), or there were significant clinical bleeding symptoms or obvious bleeding tendencies (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above baseline, or having vasculitis, etc.)
- •Within 14 days before the first administration of the study drug, any traditional Chinese medicine used for controlling cancer was used.
- •Within 30 days before the first administration, the patient received live vaccines. Including but not limited to the following: mumps, rubella, measles, chickenpox/zoster (chickenpox), yellow fever, rabies, BCG (bacillus Calmette-Guérin), and typhoid vaccine (inactivated virus vaccine is allowed); or it is expected that the patient will need to receive live vaccines or attenuated live vaccines during the study period or within 5 months after the last administration
Outcomes
Primary Outcomes
progression-free survival（PFS）
Time Frame: Half a year after all patients were enrolled
The time from the randomization to the first occurrence of imaging disease progression or death
Secondary Outcomes
- overall survival（OS）(Two years after the end of group enrollment)
- One-year progression-free survival rate(one year after treatment)
- The incidence rate of radiation pneumonitis(one year after the end of group enrollment)
- Disease Control Rate(Half a year after the study was enrolled)
- Objective response rate(Half a year after the study was enrolled)
Investigators
Study Sites (6)
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