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

NCT07485920 | Not Yet Recruiting Phase 4

• 1 other identifier: QYFYEC2026-04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 6

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.

Conditions

Limited-stage Small Cell Lung Cancer (LS-SCLC)

Keywords

Limited-stage small cell lung cancer; consolidation therapy; tislelizumab; nintedanib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

treatment arm

EXPERIMENTAL

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)

Drug: Tislelizumab and nintedanib

Interventions

Tislelizumab and nintedanib DRUG

Tislelizumab (200mgQ3W, D1) combined with nintedanib (150mg bid) until disease progression, death, or the occurrence of intolerable toxic reactions

treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• Patients with systemic autoimmune diseases that require systemic treatment, and the investigator assesses that it has an impact on the study treatment
• 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
• 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.
• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (6)

Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

Qingdao Central Hospital Affiliated to Rehabilitation University

Qingdao, Shandong, China

Location

Qingdao Municipal Hospital

Qingdao, Shandong, China

Location

Weihai Municipal Hospital

Weihai, Shandong, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Location

Zibo Fourth People's Hospital

Zibo, Shandong, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

tislelizumab; nintedanib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

jing wang

CONTACT

0532-82913035; wangstella5@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 10, 2028
• Study Completion (Estimated): January 31, 2030
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

CN (6)