Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Conditions
Brief summary
To explore the efficacy and safety of Tislelizumab combined with chemotherapy and relayed radiotherapy in the first-line treatment of extensive small cell lung cancer
Interventions
DRUGTislelizumab, Carboplatin /Cisplatin, Etoposide
Induction therapy stage LDRT: lung lesions, 15Gy/5f; Maintenance therapy phase SBRT: The main residual lesions evaluated by the investigators, 30Gy/5f；
Sponsors
Anhui Provincial Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age≥18 years old, male or female, signed Informed Consent Form (ICF); 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 3. Histologically or cytologically confirmed ES-SCLC; 4. No prior systemic treatment for ES-SCLC; 5. At least one measurable (RECIST 1.1) chest lesion capable of 15Gy/5f irradiation; 6. Adequate hematologic and end organ function;
Exclusion criteria
1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis; 2. Prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-PD-1), anti-PD-L1, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA-4) antibody; 3. Was administered a live vaccine ≤ 4 weeks before treatment; 4. Active autoimmune diseases or history of autoimmune diseases that may relapse; 5. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before treatment; 6. With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases; 7. Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to treatment, including but not limited to tuberculosis infection; 8. Received therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to starting treatment;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Baseline until PD or death, whichever occurs first or up to approximately 23 months | To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide and radiotherapy in the intent to treat (ITT) Analysis Set as measured by investigator assessed progression free survival (PFS) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration Of Response (DOR) | Baseline until partial response (PR) or complete response (CR), whichever occurs first, or up to approximately 23 months | To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide+ radiotherapy in the ITT Analysis Set as measured by investigator assessed duration of response (DOR) according to RECIST v1.1 |
| Disease Control Rate (DCR) | up to approximately 23 months | To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide + radiotherapy in the ITT Analysis Set as measured by investigator assessed disease control rate (DCR) according to RECIST v1.1 |
| Objective Response Rate (ORR) | Baseline until partial response (PR) or complete response (CR), whichever occurs or up to approximately 23 months | To evaluate the efficacy of Tislelizumab + cisplatin or carboplatin + etoposide +radiotherapy in the ITT Analysis Set as measured by investigator assessed overall response rate (ORR), according to RECIST v1.1 |
| 1-year Overall Survival (OS) rate | up to approximately 23 months | The OS rate will be defined as the proportion of participants free from OS events at 1st year after the first dose. |
| Number Of Participants Experiencing Treatment-Emergent Adverse Events | up to approximately 23 months | Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events |
| 6-moth/1-year Progression Free Survival (PFS) Rate | up to approximately 23 months | The PFS rate will be defined as the proportion of participants free from PFS events at 6 month and 1st year after the first dose. |
Countries
China
Contacts
Primary ContactShuanghu Yuan, PhD
Outcome results
None listed