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

NCT ID: NCT04647357

Last Updated: 2020-11-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-27
• Study Completion Date: 2023-12-27

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-1316

Group Type: EXPERIMENTAL

SHR-1316

Intervention Type: DRUG

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

Interventions

SHR-1316

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Xiaorong Dong

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Xiaorong Dong, PhD

Role: CONTACT

Phone: 027-85872859

Email: xiaorongdong@hust.edu.cn

Other Identifiers

LS-SCLC-MT-IIT-SHR1316

Identifier Type: -

Identifier Source: org_study_id