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

NCT07815223 | Recruiting Phase 2

• 1 other identifier: IIT2025068
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SCLC, Limited Stage

Keywords

consolidation therapy

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS)

  Up to 36 months

• Overall Survival (OS)

  Up to 48 months

Secondary Outcomes (5)

• 6- and 12-month progression-free survival rates

  Up to 36 months

• Objective Response Rate (ORR)

  Up to 36 months

• Disease Control Rate (DCR)

  Up to 36 months

• Duration of Response (DoR)

  Up to 36 months

• Adverse Events (AEs)

  Up to 36 months

Study Arms (1)

Tislelizumab + Anlotinib

EXPERIMENTAL

Drug: Tislelizumab + Anlotinib

Interventions

Tislelizumab + Anlotinib DRUG

Tislelizumab 200 mg on Day 1 plus anlotinib 10 mg on Days 1-14 of each 3-week cycle.

Tislelizumab + Anlotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• Received any traditional Chinese herbal medicine for cancer control within 14 days before the first dose;
• Required systemic corticosteroids equivalent to more than 10 mg per day of prednisone or other immunosuppressive treatment within 14 days before the first dose;
• Received a live vaccine within 4 weeks before the first dose; inactivated seasonal influenza vaccines are permitted, but live intranasal influenza vaccines are not;
• Underwent major surgery requiring general anaesthesia within 28 days before the first dose;
• Had previous allogeneic stem-cell or organ transplantation;
• Have clinically significant pericardial effusion;
• Have uncontrolled pleural effusion or ascites requiring drainage within 2 weeks before enrolment;
• Have active autoimmune disease or a history of autoimmune disease with a risk of recurrence;
• Have a history of interstitial lung disease or non-infectious pneumonitis, or uncontrolled systemic disease, including diabetes, hypertension, pulmonary fibrosis, or acute lung disease;
• Have a severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral treatment within 2 weeks before the first dose, including tuberculosis;
• 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;
• 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;
• Have a known history of HIV infection;
• Have clinically significant cardiovascular risk factors;

Sponsors & Collaborators

• Yantai Yuhuangding Hospital: lead
• BeiGene: collaborator
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

Yantai Yuhuangding Hospital

Yantai, Shandong, China

RECRUITING

MeSH Terms

Interventions

tislelizumab; anlotinib

Central Study Contacts

Jinbo Ma

CONTACT

+86 133 3638 9127; yhdmajb@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: November 4, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)