Limited-stage Small-cell Lung Cancer
Conditions
Brief summary
This study is an open-label, multicenter, phase II clinical study designed to evaluate the preliminary efficacy, safety, and tolerability of SHR-7787 in combination with Adebrelimab in patients with limited-stage small cell lung cancer.
Interventions
SHR-7787 injection.
DRUGSHR-1316
SHR-1316 (Adebrelimab) Injection.
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
SHR-7787 combined with SHR-1316.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily participate in this clinical study, understand the study procedures, and be able to sign the informed consent form (ICF) in writing. 2. Aged 18 to 75 years (inclusive), of any gender. 3. Histologically or cytologically confirmed unresectable limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemotherapy and radiation therapy. 4. ECOG performance status score of 0 or 1. 5. Estimated survival time of more than 3 months. 6. Have adequate bone marrow and organ function. 7. Female trial participants of childbearing potential must agree to use highly effective contraception from the time of signing the informed consent form until 6 months after the last dose of the investigational drug, and avoid donating eggs.
Exclusion criteria
1. Combined small cell lung cancer or any transformed small cell lung cancer. 2. History of other malignancies within 5 years prior to the first dose of the study drug. 3. Severe cardiovascular or cerebrovascular diseases. 4. Bleeding symptoms of significant clinical relevance within 3 months prior to the first dose of the study drug. 5. Malignant pleural effusion or malignant pericardial effusion. 6. Severe infection within 4 weeks prior to the initiation of study treatment. 7. Active tuberculosis infection within 1 year prior to enrollment, identified by medical history or imaging examination. 8. History of immunodeficiency. 9. Active, known, or suspected autoimmune disease, or a history of autoimmune disease. 10. Prior treatment with immune checkpoint inhibitors (ICIs). 11. Undergone major organ surgery within 4 weeks prior to the first dose of the study drug. 12. Any other factors that, in the judgment of the investigator, may affect the study results or force premature termination of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events (AEs) | Approximately 3 weeks | The dose expansion part of Phase 1 |
| Incidence and severity of serious adverse events (SAEs) | Approximately 3 weeks | The dose expansion part of Phase 1 |
| Progression-Free Survival (PFS) | Approximately 16 months | The dose expansion part of Phase 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Approximately 16 months | The dose expansion part of Phase 1 |
| Objective Response Rate (ORR) | Approximately 16 months | The dose expansion part of Phase 1 |
| Duration of Response (DoR) | Approximately 16 months | The dose expansion part of Phase 1 |
| Anti-Drug Antibody (ADA) of SHR-7787 | Approximately 16 months | The dose expansion part of Phase 1 |
| Disease Control Rate (DCR) | Approximately 16 months | The dose expansion part of Phase 1 |
| Incidence and severity of adverse events (AEs) | Approximately 16 months | The efficacy expansion part of Phase 2 |
| Incidence and severity of serious adverse events (SAEs) | Approximately 16 months | The efficacy expansion part of Phase 2 |
Countries
China
Contacts
CONTACTXiaoxia Lu
Outcome results
None listed