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

Limited-stage Small Cell Lung Cancer, LS-SCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04647357
• Other study ID #: LS-SCLC-MT-IIT-SHR1316
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 27, 2020
• Est. completion date: December 27, 2023

Study information

• Verified date: November 2020
• Source: Wuhan Union Hospital, China
• Contact: Xiaorong Dong, PhD
• Phone: 027-85872859
• Email: xiaorongdong[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 27, 2023
• Est. primary completion date: May 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Limited-stage Small Cell Lung Cancer, LS-SCLC
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• SHR-1316
Anti-PD-L1 antibody,Maintenance therapy, The drug was administered every three weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	progression-free survival	Up to approximately 24 months