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

March 1, 2021 updated by: Qilu Hospital of Shandong University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: Approximately 3 years
To assess the efficacy of Camrelizumab and Fluzoparib combination therapy in terms of PFS
Approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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