A Phase II Study of Tislelizumab Plus Anlotinib Consolidation After Chemoradiotherapy in LS-SCLC

A Prospective, Single-Arm, Phase II Study of Tislelizumab Plus Anlotinib as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Progression After Concurrent or Sequential Chemoradiotherapy

This prospective, single-arm, phase II study aims to evaluate the efficacy and safety of tislelizumab plus anlotinib as consolidation therapy in patients with limited-stage small cell lung cancer (LS-SCLC) who have not progressed following concurrent or sequential chemoradiotherapy.

Study Overview

• Status: Recruiting
• Conditions: SCLC, Limited Stage
• Intervention / Treatment: Drug: Tislelizumab + Anlotinib

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jinbo Ma; Phone Number: +86 133 3638 9127; Email: yhdmajb@163.com

Study Locations

• China
  • Shandong
    • Yantai, Shandong, China
      • Recruiting
      • Yantai Yuhuangding Hospital
      • Contact: Jinbo Ma; Phone Number: +86 133 3638 9127; Email: yhdmajb@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provide written informed consent and be willing and able to comply with study requirements and scheduled assessments;
2. Be aged 18-75 years at the time of consent;
3. Have an ECOG performance status of 0 or 1;
4. Have histologically or cytologically confirmed small-cell lung cancer;
5. Have radiologically confirmed limited-stage disease;
6. Have achieved a complete response, partial response, or stable disease after concurrent or sequential chemoradiotherapy, according to RECIST version 1.1;
7. Have a life expectancy of at least 3 months;
8. Have adequate organ function.

Exclusion Criteria:

1. Received systemic immunostimulatory agents, including interferons, interleukin 2, or tumour necrosis factor, within 4 weeks or five half-lives before the first dose of study treatment, whichever is longer; previous cancer vaccines are permitted;
2. Received any traditional Chinese herbal medicine for cancer control within 14 days before the first dose;
3. Required systemic corticosteroids equivalent to more than 10 mg per day of prednisone or other immunosuppressive treatment within 14 days before the first dose;
4. Received a live vaccine within 4 weeks before the first dose; inactivated seasonal influenza vaccines are permitted, but live intranasal influenza vaccines are not;
5. Underwent major surgery requiring general anaesthesia within 28 days before the first dose;
6. Had previous allogeneic stem-cell or organ transplantation;
7. Have clinically significant pericardial effusion;
8. Have uncontrolled pleural effusion or ascites requiring drainage within 2 weeks before enrolment;
9. Have active autoimmune disease or a history of autoimmune disease with a risk of recurrence;
10. Have a history of interstitial lung disease or non-infectious pneumonitis, or uncontrolled systemic disease, including diabetes, hypertension, pulmonary fibrosis, or acute lung disease;
11. Have a severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral treatment within 2 weeks before the first dose, including tuberculosis;
12. Have had another active malignancy within 2 years before the first dose, except the cancer under investigation or definitively treated localised cancers, including resected basal-cell or squamous-cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast;
13. Have untreated chronic hepatitis B, chronic HBV infection with an HBV DNA concentration of at least 500 IU/mL (2500 copies/mL), or active hepatitis C;
14. Have a known history of HIV infection;
15. Have clinically significant cardiovascular risk factors;
16. Have unresolved toxicities from previous anticancer treatment that have not returned to baseline or stabilised, except adverse events unlikely to pose a safety risk, such as alopecia, neuropathy, or specified laboratory abnormalities;
17. Have a history of severe hypersensitivity to monoclonal antibodies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tislelizumab + Anlotinib	Drug: Tislelizumab + Anlotinib; Tislelizumab 200 mg on Day 1 plus anlotinib 10 mg on Days 1-14 of each 3-week cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	Up to 48 months
Progression Free Survival (PFS)	Up to 36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate (ORR)	Up to 36 months
Disease Control Rate (DCR)	Up to 36 months
Adverse Events (AEs)	Up to 36 months
6- and 12-month progression-free survival rates	Up to 36 months
Duration of Response (DoR)	Up to 36 months

Collaborators and Investigators

• Sponsor: Yantai Yuhuangding Hospital
• Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: September 7, 2026
• First Submitted That Met QC Criteria: September 7, 2026
• First Posted (Actual): September 11, 2026

Study Record Updates

• Last Update Posted (Actual): September 11, 2026
• Last Update Submitted That Met QC Criteria: September 7, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: consolidation therapy
• Additional Relevant MeSH Terms: anlotinib; tislelizumab
• Other Study ID Numbers: IIT2025068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No