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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitors

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jisheng Li, PhD; Phone Number: 0531-82169841; Email: lijisheng@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Camrelizumab+Fluzoparib	Drug: Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitors; Camrelizumab+Fluzoparib：Q3W, Administration until disease progression or intolerable

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	To assess the efficacy of Camrelizumab and Fluzoparib combination therapy in terms of PFS	Approximately 3 years

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 6, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Immunologic Factors; Antibodies; Poly(ADP-ribose) Polymerase Inhibitors
• Other Study ID Numbers: ES-SCLC-2nd-IIT-SHR3162-APA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No