Extensive-stage Small Cell Lung Cancer
Conditions
Keywords
SHR1316, Chemotherapy, Radiotherapy
Brief summary
This study is a one arm, open, single center phase II study. The main purpose of this study was to evaluate the tolerance and preliminary efficacy of SHR1316 combined with chest radiotherapy after induction therapy.
Detailed description
This is a single-arm, single-center phase II study. Eligible subjects will receive the following treatment regimens: 4\ 6 cycles of SHR1316 combined with EP/EC (etoposide, 100mg/m2, D1-3, q3w and cisplatin, 75mg/m², D1, q3w or carboplatin, AUC=5, D1, q3w). Patients with response sequentially received adebrelimab combined with chest radiotherapy based on investigator decision. Patients then the maintenance therapy with adebrelimab until disease progression or intolerable AEs.
Interventions
DRUGSHR1316
Anti-PD-L1 antibody
DRUGCarboplatin
Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
DRUGEtoposide
Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
RADIATIONRadiation therapy
Thoracic radiation therapy ,TRT
DRUGCisplatin
Cisplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
Sponsors
Shandong Cancer Hospital and Institute
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
* Confirmed diagnosis of Extensive small cell lung cancer * Eastern Cooperative Oncology Group performance status (PS) of 0 to 1 * 18 to 75 years old * The function of vital organs meets the following requirements. WBC ≥ 3.0 × 10\^9/L, ANC≥1.5×10\^9/L, PLT≥100×10\^9/L, Hb≥9g/dL, ALT and AST ≤2.5 times ULN, TBIL ≤1.5 x ULN, CREA ≤1.5 times ULN or CCr≥50mL/min. INR≤1.5 x ULN, APTT ≤1.5 x ULN * have not received first-line systemic therapy or immunosuppressive therapy for es-sclc * The estimated survival period is more than 8 weeks * With measurable lesion defined by the RECIST v1.1: Previously irradiated lesions may only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation and the previously irradiated lesion is not the only site of disease; * Signed written informed consent prior to study entry
Exclusion criteria
* Active or untreated CNS metastases * Leptomeningeal diseases * Uncontrolled or symptomatic hypercalcemia * Active, known or suspected autoimmune diseases * have received any T cell co stimulation or immune checkpoint therapy * Corticosteroids (\> 10 mg / day prednisone or equivalent) or other immunosuppressants were used within 14 days before the first dose of study drug. * Subjects had active infections. * Failing to properly control the clinical symptoms or disease of the heart * Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation * Known to be allergic to the study drug or excipients, known to have a serious allergic reaction to any kind of monoclonal antibody; have a history of hypersensitivity to cisplatin or etoposide * According to the researcher's judgment, there are other factors that may lead to the termination of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival （OS） | Up to approximately 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Up to approximately 36 months | Safety, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) per CTCAE 5.0 criteria |
| Duration of Response (DOR) | Up to approximately 36 months | — |
| progression-free survival (PFS) | Up to approximately 36 months | — |
| disease control rate (DCR) | Up to approximately 36 months | — |
| 6- and 12-month PFS rates | 6 Months and 12 Months | Percentage of Participants Alive and Without PD, as Assessed by the Investigator Using RECIST v1.1, at 6 Months and 12 Months |
| 1- and 2-year OS rates | 1 Year and 2 Years | Percentage of Participants Alive at 1 Year and 2 Years |
| Objective Response Rate (ORR) | Up to approximately 36 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of ctDNA status | Up to approximately 36 months | Change of circulating tumor DNA (ctDNA) status in blood before and after receving treatment |
Countries
China
Outcome results
None listed