A Phase II Clinical Study of SHR-1316 Combined With Chemotherapy and Chest Radiotherapy in Extensive Small Cell Lung Cancer

S

Shandong First Medical University

Status and phase

Not yet enrolling
Phase 2

Conditions

Extensive-stage Small Cell Lung Cancer

Treatments

Drug: Chemotherapy
Drug: SHR1316
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.

Enrollment

67 estimated 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 × 109/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≥60mL/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
  • Measurable lesions outside of the field of chest radiotherapy(iRECIST)
  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

67 participants in 1 patient group

SHR1316+Chemotherapy +Radiotherapy
Experimental group
Description:
Paiticipant receive SHR-1316 、Chemotherapy and Radiotherapy
Treatment:
Radiation: Radiation therapy
Drug: SHR1316
Drug: Chemotherapy

Trial contacts and locations

0

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Central trial contact

JinMing Yu, PhD

Data sourced from clinicaltrials.gov

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