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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2024-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Extensive-stage Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SHR1316+Chemotherapy +Radiotherapy

Paiticipant receive SHR-1316 、Chemotherapy and Radiotherapy

Group Type EXPERIMENTAL

SHR1316

Intervention Type DRUG

Anti-PD-L1 antibody

Carboplatin

Intervention Type DRUG

Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).

Etoposide

Intervention Type DRUG

Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).

Radiation therapy

Intervention Type RADIATION

Thoracic radiation therapy ,TRT

Cisplatin

Intervention Type DRUG

Cisplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).

Interventions

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SHR1316

Anti-PD-L1 antibody

Intervention Type DRUG

Carboplatin

Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).

Intervention Type DRUG

Etoposide

Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).

Intervention Type DRUG

Radiation therapy

Thoracic radiation therapy ,TRT

Intervention Type RADIATION

Cisplatin

Cisplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).

Intervention Type DRUG

Other Intervention Names

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Adebrelimab

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No