Tislelizumab plus Anlotinib after chemoradiotherapy in limited-stage SCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm phase II study enrolling adults with limited-stage SCLC who have not progressed after chemoradiotherapy. Participants receive a consolidation regimen of tislelizumab plus anlotinib, with safety and efficacy as the main aims. Eligibility includes good performance status, measurable response to prior therapy, and adequate organ function. The study is conducted at Yantai Yuhuangding Hospital with collaboration from BeiGene and Chia Tai Tianqing. The trial does not include a control arm for direct comparison within the protocol.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yantai Yuhuangding Hospital
  Yantai, Shandong, China Recruiting

Study contacts

• Study coordinator: Jinbo Ma
• Email: yhdmajb@163.com
• Phone: +86 133 3638 9127

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.