SCLC, Limited StagePhase 2NCT07815223
A Phase II Study of Tislelizumab Plus Anlotinib Consolidation After Chemoradiotherapy in LS-SCLC
A Phase 2 study testing Tislelizumab + Anlotinib in people with SCLC, Limited Stage, run by Yantai Yuhuangding Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SCLC, Limited Stage
- What is being tested?
- Tislelizumab + Anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2025to 31 Dec 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 17Show fewer
- 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;
- 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;
- Have a history of severe hypersensitivity to monoclonal antibodies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong
Jinbo Ma, +86 133 3638 9127, yhdmajb@163.com
About this study
Official title: 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.
- Conditions
- SCLC, Limited Stage
- Being tested
- Tislelizumab + Anlotinib
- Keywords
- consolidation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab + AnlotinibDrug
Tislelizumab 200 mg on Day 1 plus anlotinib 10 mg on Days 1-14 of each 3-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab + Anlotinib | Experimental | Not described Receives: Drug: Tislelizumab + Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Measured: Up to 36 months
Overall Survival (OS)
Measured: Up to 48 months
Secondary outcomes (5)
6- and 12-month progression-free survival rates
Measured: Up to 36 months
Objective Response Rate (ORR)
Measured: Up to 36 months
Disease Control Rate (DCR)
Measured: Up to 36 months
Duration of Response (DoR)
Measured: Up to 36 months
Adverse Events (AEs)
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start4 Nov 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC, Limited StageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yantai Yuhuangding Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BeiGene, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815223
- Sponsor's protocol ID
- IIT2025068
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No