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

Small Cell Lung Cancer Clinical Trial

Official title:

A Phase II, Open, Single-center Study of PD-1 Antibody and PARP Inhibitor as Consolidation Treatment for Patients With Extensive Stage Small Cell Lung Cancer Who Have Not Progressed After First-line Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04782089
• Other study ID #: ES-SCLC-2nd-IIT-SHR3162-APA
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 6, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2021
• Source: Qilu Hospital of Shandong University
• Contact: Jisheng Li, PhD
• Phone: 0531-82169841
• Email: lijisheng[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 1, 2024
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitors
Camrelizumab+Fluzoparib:Q3W, Administration until disease progression or intolerable

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University	Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	To assess the efficacy of Camrelizumab and Fluzoparib combination therapy in terms of PFS	Approximately 3 years