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

SHR-1316 Plus Chemotherapy and Sequential Thoracic Radiotherapy as First-line Therapy for Extensive-stage Small-Cell Lung Cancer (ES-SCLC): a Phase II Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Extensive-stage Small Cell Lung Cancer
• Intervention / Treatment: Drug: Carboplatin; Drug: Etoposide; Drug: SHR1316; Radiation: Radiation therapy; Drug: Cisplatin

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Shandong Cancer Hospital and Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SHR1316+Chemotherapy +Radiotherapy; Paiticipant receive SHR-1316 、Chemotherapy and Radiotherapy

Drug: Carboplatin; Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).; Drug: Etoposide; Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).; Drug: SHR1316; Anti-PD-L1 antibody; Other Names: Adebrelimab; Radiation: Radiation therapy; Thoracic radiation therapy ,TRT; Drug: Cisplatin; Cisplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival （OS）	Up to approximately 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival (PFS)		Up to approximately 36 months
Objective Response Rate (ORR)		Up to approximately 36 months
disease control rate (DCR)		Up to approximately 36 months
Duration of Response (DOR)		Up to approximately 36 months
Adverse events	Safety, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) per CTCAE 5.0 criteria	Up to approximately 36 months
6- and 12-month PFS rates	Percentage of Participants Alive and Without PD, as Assessed by the Investigator Using RECIST v1.1, at 6 Months and 12 Months	6 Months and 12 Months
1- and 2-year OS rates	Percentage of Participants Alive at 1 Year and 2 Years	1 Year and 2 Years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of ctDNA status	Change of circulating tumor DNA (ctDNA) status in blood before and after receving treatment	Up to approximately 36 months

Collaborators and Investigators

• Sponsor: Shandong Cancer Hospital and Institute
• Investigators: Principal Investigator: JinMing Yu, Phd, Shandong Cancer Hospital and Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 29, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: SHR1316, Chemotherapy, Radiotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Carboplatin; Etoposide
• Other Study ID Numbers: ES-SCLC-1st-IIT-SHR1316-CRT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No