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A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer | Clinical Trials | Clareo Health

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

A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer Without Progression After First Line Concurrent Chemoradiotherapy Treatment

NCT04647357•Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•1. The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
•2. Mixed SCLC or NSCLC confirmed by histology;
•3. Locally advanced small cell lung cancer receiving sequential chemoradiotherapy;
•4. Have received anti-tumor therapy of systemic immune checkpoint inhibitors for SCLC;
•5. Extensive SCLC;
•6. Operable SCLC (clinical stage T1-2N0, except for those who are contraindicated or refuse surgery);
•7. Interstitial pneumonia
•8. 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.
•9. HIV, active Hepatitis B or Hepatitis C infection

Key Dates

Start Date

November 27, 2020

Primary Completion Date

May 27, 2023

Completion Date

December 27, 2023

Last Updated

November 30, 2020

Enrollment

ESTIMATED participants

Conditions

Limited-stage Small Cell Lung Cancer, LS-SCLC

Interventions

SHR-1316

DRUG

Contacts

Xiaorong Dong, PhD

CONTACT

027-85872859 xiaorongdong@hust.edu.cn