SCLC, Limited Stage
Conditions
Keywords
consolidation therapy
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.
Interventions
DRUGTislelizumab + Anlotinib
Tislelizumab 200 mg on Day 1 plus anlotinib 10 mg on Days 1-14 of each 3-week cycle.
Sponsors
Yantai Yuhuangding Hospital
BeiGene
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | Up to 36 months |
| Overall Survival (OS) | Up to 48 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
CONTACTJinbo Ma
Outcome results
None listed