Study of PD-1 Antibody and PARP Inhibitor in Extensive Stage Small Cell Lung Cancer

NCT ID: NCT04782089

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2024-06-01

Brief Summary

This is a Phase II, Open, Single-center Study of Camrelizumab and Fluzoparib as Consolidation Treatment for Patients With Extensive stage small cell lung cancer Who Have Not Progressed after first-line treatment

Conditions

Small Cell Lung Cancer

Study Design

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

Study Groups

Camrelizumab+Fluzoparib

Group Type: EXPERIMENTAL

Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitors

Intervention Type: DRUG

Camrelizumab+Fluzoparib：Q3W, Administration until disease progression or intolerable

Interventions

Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitors

Camrelizumab+Fluzoparib：Q3W, Administration until disease progression or intolerable

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. All subjects were required to sign the informed consent before starting the study;

2. Histologically documented Extensive stage small cell lung cancer；

3. ECOG PS 0~1 ；

4. 18-75 years；

5. According to recist1.1, CR or PR was achieved after 4-6 cycles of first-line etoposide and platinum chemotherapy;

6. .Life expectancy ≥ 3 months；

Exclusion Criteria

1. Recurrence or distant metastasis of localized small cell lung cancer after chemotherapy or concurrent chemoradiotherapy；

2. Active infection including tuberculosis, HIV, hepatitis B and C；

3. Interstitial pneumonia (ILD), drug-induced pneumonia, radiation-induced pneumonia requiring steroid therapy or active pneumonia with clinical symptoms, or other moderate to severe lung diseases that seriously affect lung function;

4. Severe infection existed, including but not limited to infection complications, bacteremia, severe pneumonia, etc;

5. Symptomatic brain metastasis and cancerous meningitis;

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

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jisheng Li, PhD

Role: CONTACT

lijisheng@sdu.edu.cn

0531-82169841

Other Identifiers

ES-SCLC-2nd-IIT-SHR3162-APA

Identifier Type: -

Identifier Source: org_study_id