SHR-1316 Combined With Chemotherapy and Chest Radiotherapy in ES-SCLC

Shandong First Medical University

Status and phase

Active, not recruiting

Phase 2

Conditions

Extensive-stage Small Cell Lung Cancer

Treatments

Drug: Etoposide

Drug: Carboplatin

Drug: SHR1316

Drug: Cisplatin

Radiation: Radiation therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04562337

ES-SCLC-1st-IIT-SHR1316-CRT

Details and patient eligibility

About

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.

Full 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.

Enrollment

67 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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