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

Phase 2

• Conditions: Limited-stage Small Cell Lung Cancer, LS-SCLC
• Interventions: Drug: SHR-1316

• Registration Number: NCT04647357
• Lead Sponsor: Wuhan Union Hospital, China

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study Start: 2020-11-27
• Study First Submitted: 2020-11-27
• Study First Submitted QC: 2020-11-27
• Last Update Submitted: 2020-11-27
• Study First Posted: 2020-11-30
• Last Update Posted: 2020-11-30
• Primary Completion: 2023-05-27
• Study Completion: 2023-12-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-1316	SHR-1316	-

Primary Outcome Measures

Name	Time	Method
PFS	Up to approximately 24 months	progression-free survival