A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer

NCT04647357 | Unknown Phase 2 DMC

• 1 other identifier: LS-SCLC-MT-IIT-SHR1316
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

SHR-1316 as Maintenance therapy for limited stage small cell lung cancer without progression after first line platinum based concurrent chemoradiotherapy

Conditions

Limited-stage Small Cell Lung Cancer, LS-SCLC

Outcome Measures

Primary Outcomes (1)

• PFS

  progression-free survival

  Up to approximately 24 months

Study Arms (1)

SHR-1316

EXPERIMENTAL

Drug: SHR-1316

Interventions

SHR-1316 DRUG

Anti-PD-L1 antibody，Maintenance therapy, The drug was administered every three weeks

SHR-1316

Eligibility Criteria

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

You may qualify if:

• The age is 18-75 years old (including both ends), regardless of gender;
• Histologically confirmed limited stage small cell lung cancer ;
• ECOG PS 0 \~ 1;
• Patients received at least 2 cycles of platinum based chemotherapy and radiotherapy, and completed within 1 to 42 days before the first medication.
• The last chemotherapy must be finished before or at the same time of radiotherapy.
• The disease did not progress after concurrent chemoradiotherapy;
• The expected survival time was more than 3 months;
• Pulmonary function: FEV1 \> 70%;

You may not qualify if:

• The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
• Mixed SCLC or NSCLC confirmed by histology;
• Locally advanced small cell lung cancer receiving sequential chemoradiotherapy;
• Have received anti-tumor therapy of systemic immune checkpoint inhibitors for SCLC;
• Extensive SCLC;
• Operable SCLC (clinical stage T1-2N0, except for those who are contraindicated or refuse surgery);
• Interstitial pneumonia
• History of active, known or suspected autoimmune diseases and autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.
• HIV, active Hepatitis B or Hepatitis C infection

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xiaorong Dong, PhD

CONTACT

027-85872859; xiaorongdong@hust.edu.cn

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: Director

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: November 30, 2020
• Study Start: November 27, 2020
• Primary Completion: May 27, 2023
• Study Completion: December 27, 2023
• Last Updated: November 30, 2020

Record last verified: 2020-11