Can two drugs keep Limited-Stage lung cancer from returning?
NCT ID NCT07815223
First seen Sep 11, 2026 · Last updated Sep 11, 2026
Summary
Researchers are testing whether adding tislelizumab and anlotinib after chemoradiotherapy can help people with limited-stage small cell lung cancer live longer without their cancer coming back. The study enrolls adults aged 18 to 75 whose cancer has not worsened after concurrent or sequential chemoradiotherapy. Participants receive tislelizumab and anlotinib in 3-week cycles, and researchers track how long they live without progression, overall survival, and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tislelizumab plus anlotinib
- What this could lead to
- If it works, this combination could offer a way to extend the time before limited-stage small cell lung cancer returns after chemoradiotherapy.
- What could go wrong
- This is a small, single-arm phase II study with 20 participants, so it cannot prove the combination works better than standard care. Immunotherapy and anti-angiogenic drugs can cause serious side effects, and the results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Yantai Yuhuangding Hospital
RECRUITINGYantai, Shandong, China
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