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

NCT04562337 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: ES-SCLC-1st-IIT-SHR1316-CRT
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Extensive-stage Small Cell Lung Cancer

Keywords

SHR1316, Chemotherapy, Radiotherapy

Outcome Measures

Primary Outcomes (1)

• overall survival （OS）

  Up to approximately 36 months

Secondary Outcomes (7)

• 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

  Up to approximately 36 months

Other Outcomes (1)

• Change of ctDNA status

  Up to approximately 36 months

Study Arms (1)

SHR1316+Chemotherapy +Radiotherapy

EXPERIMENTAL

Paiticipant receive SHR-1316 、Chemotherapy and Radiotherapy

Drug: SHR1316; Drug: Carboplatin; Drug: Etoposide; Radiation: Radiation therapy; Drug: Cisplatin

Interventions

SHR1316 DRUG

Anti-PD-L1 antibody

Also known as: Adebrelimab

SHR1316+Chemotherapy +Radiotherapy

Carboplatin DRUG

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

SHR1316+Chemotherapy +Radiotherapy

Etoposide DRUG

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

SHR1316+Chemotherapy +Radiotherapy

Radiation therapy RADIATION

Thoracic radiation therapy ,TRT

SHR1316+Chemotherapy +Radiotherapy

Cisplatin DRUG

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

SHR1316+Chemotherapy +Radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of Extensive small cell lung cancer
• Eastern Cooperative Oncology Group performance status (PS) of 0 to 1
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Location

Related Publications (1)

• Chen D, Zou B, Li B, Gao A, Huang W, Shao Q, Meng X, Zhang P, Tang X, Hu X, Zhang Y, Guo J, Zhao C, Yuan J, Li Q, Zhu C, Yu J, Wang L. Adebrelimab plus chemotherapy and sequential thoracic radiotherapy as first-line therapy for extensive-stage small-cell lung cancer (ES-SCLC): a phase II trial. EClinicalMedicine. 2024 Aug 21;75:102795. doi: 10.1016/j.eclinm.2024.102795. eCollection 2024 Sep.

  PMID: 39252865 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Carboplatin; Etoposide; Radiotherapy; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• JinMing Yu, PhD

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Shandong Cancer Hospital and Institute

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 24, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)