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Clinical Trial NCT07485920 for Limited-stage Small Cell Lung Cancer (LS-SCLC) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Prospective, Multicenter Exploratory Clinical Study on Consolidation Therapy With Tislelizumab Combined With Nintedanib for Limited-stage Small Cell Lung Cancer Phase 4 20

Not yet recruiting
Clinical Trial NCT07485920 is designed to study Treatment for Limited-stage Small Cell Lung Cancer (LS-SCLC). This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on 1 May 2026 until the study accrues 20 participants. Led by The Affiliated Hospital of Qingdao University, this study is expected to complete by 31 January 2030. The latest data from ClinicalTrials.gov was last updated on 20 March 2026.
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.
Official Title

A Prospective, Multicenter Exploratory Clinical Study on Consolidation Therapy With Tislelizumab Combined With Nintedanib for Limited-stage Small Cell Lung Cancer

Conditions
Limited-stage Small Cell Lung Cancer (LS-SCLC)
Other Study IDs
  • QYFYEC2026-04
NCT ID Number
NCT07485920
Start Date (Actual)
2026-05-01
Last Update Posted
2026-03-20
Completion Date (Estimated)
2030-01-31
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
Limited-stage small cell lung cancer
consolidation therapy
tislelizumab
nintedanib
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimentaltreatment arm
Patients with limited-stage small cell lung cancer who did not progress after induction chemoradiotherapy were treated with tislelizumab (200mg Q3W, D1) combined with nintedanib (150mg,bid)
Tislelizumab and nintedanib
Tislelizumab (200mgQ3W, D1) combined with nintedanib (150mg bid) until disease progression, death, or the occurrence of intolerable toxic reactions
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
progression-free survival（PFS）
The time from the randomization to the first occurrence of imaging disease progression or death
Half a year after all patients were enrolled
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
overall survival（OS）
The time from the first administration of the drug to death due to any cause
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
The proportion of patients whose tumors achieved remission (PR + CR) and stable lesions (SD).
Half a year after the study was enrolled
Objective response rate
Half a year after the study was enrolled
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Have a thorough understanding of this study and have voluntarily signed the informed consent form;
  2. Age ≥ 18 years old, gender not restricted;
  3. ECOG score 0-1;
  4. Histologically or cytologically confirmed as limited-stage small cell lung cancer;
  5. At least one measurable lesion (according to RECISTv1.1 criteria);
  6. Expected survival ≥ 3 months;
  7. Prophylactic cranial radiotherapy is permitted before consolidation therapy;
  8. 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).
  9. Willing and able to comply with the study plan's visits, treatment plan, laboratory tests and other research procedures;
  10. 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.

  1. There are patients with lung metastasis from other primary malignant tumors.
  2. 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.
  3. 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.
  4. 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.
  5. Patients whose blood pressure control is not satisfactory after drug treatment (systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg).
  6. Patients with factors that significantly affect the absorption of oral medications, such as inability to swallow, chronic diarrhea, and intestinal obstruction, etc.
  7. 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.
  8. 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.)
  9. Within 14 days before the first administration of the study drug, any traditional Chinese medicine used for controlling cancer was used.
  10. 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
  11. Within 14 days before the first administration of the study drug, any situation where systemic treatment with corticosteroids (prednisone or equivalent drugs > 10 mg/day) or other immunosuppressive drugs is required, and the investigator assesses that it has an impact on the study treatment
  12. Patients with systemic autoimmune diseases that require systemic treatment, and the investigator assesses that it has an impact on the study treatment
  13. Patients with interstitial lung disease, non-infectious pneumonia, or other uncontrolled diseases, including diabetes, pulmonary fibrosis, acute lung disease, etc., and the investigator assesses that it has an impact on the study treatment
  14. Patients with a significant history of major diseases or clinical manifestations that may affect the function of organ systems, and the investigator assesses that it has an impact on the study treatment.
  15. Within 14 days before the first administration of the study drug, severe chronic or active infections (including tuberculosis infection, etc.) that require systemic antibacterial, antifungal, or antiviral treatment (including HBsAg positive in the screening period and HBV-DNA detection value higher than the upper limit of the laboratory test department of the research center; (for subjects who tested HBV-DNA content < 500 IU/mL within 28 days before enrollment and have received at least 14 days of local standard antiviral treatment and are willing to continue antiviral treatment during the study period, they can be enrolled); active hepatitis C (defined as HBsAb positive in the screening period and HCV-RNA positive) subjects.
  16. Uncontrolled active hepatitis B (defined as HBsAg positive in the screening period and HBV-DNA detection value higher than the upper limit of the laboratory test department of the research center; (for subjects who tested HBV-DNA content < 500 IU/mL within 28 days before enrollment and have received at least 14 days of local standard antiviral treatment and are willing to continue antiviral treatment during the study period, they can be enrolled); active hepatitis C (defined as HBsAb positive in the screening period and HCV-RNA positive) subjects
  17. Known human immunodeficiency virus (HIV) infection (known HIV antibody positive)
  18. Grade III-IV congestive heart failure (New York Heart Association classification), poorly controlled and with clinically significant arrhythmias
  19. Any occurrence of arterial thrombosis, embolism or ischemia within 6 months prior to the inclusion in the treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, etc.
  20. Concurrent participation in another therapeutic clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
  21. Medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the test results and prevent the subject from fully participating in the study, or other conditions that the investigator considers as other potential risks and unsuitable for inclusion in the study. The investigator considers that there are other potential risks that make participation in this study unsuitable.
The Affiliated Hospital of Qingdao University logoThe Affiliated Hospital of Qingdao University
Study Central Contact
Contact: jing wang, 0532-82913035, [email protected]
6 Study Locations in 1 Countries

Shandong

Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
jing wang, Contact, 0532-82913035, [email protected]
Qingdao Central Hospital Affiliated to Rehabilitation University, Qingdao, Shandong, China
zhen zhang, Contact, [email protected]
Qingdao Municipal Hospital, Qingdao, Shandong, China
wei chen, Contact, [email protected]
Weihai Municipal Hospital, Weihai, Shandong, China
fujun Yang, Contact, [email protected]
Yantai Yuhuangding Hospital, Yantai, Shandong, China
aina Liu, Contact, [email protected]
Zibo Fourth People's Hospital, Zibo, Shandong, China
Fanghan Wang, Contact, [email protected]