NCT04782089

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 6, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 4, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

March 1, 2021

Last Update Submit

March 1, 2021

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

    To assess the efficacy of Camrelizumab and Fluzoparib combination therapy in terms of PFS

    Approximately 3 years

Study Arms (1)

Camrelizumab+Fluzoparib

EXPERIMENTAL
Drug: Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitors

Interventions

Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitorsDRUG

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

Camrelizumab+Fluzoparib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects were required to sign the informed consent before starting the study;
  • Histologically documented Extensive stage small cell lung cancer；
  • ECOG PS 0\~1 ；
  • years；
  • According to recist1.1, CR or PR was achieved after 4-6 cycles of first-line etoposide and platinum chemotherapy;
  • Life expectancy ≥ 3 months；

You may not qualify if:

  • Recurrence or distant metastasis of localized small cell lung cancer after chemotherapy or concurrent chemoradiotherapy；
  • Active infection including tuberculosis, HIV, hepatitis B and C；
  • 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;
  • Severe infection existed, including but not limited to infection complications, bacteremia, severe pneumonia, etc;
  • Symptomatic brain metastasis and cancerous meningitis;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Jisheng Li, PhD

CONTACT

0531-82169841lijisheng@sdu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 4, 2021

Study Start

May 6, 2021

Primary Completion

May 1, 2023

Study Completion

June 1, 2024

Last Updated

March 4, 2021

Record last verified: 2021-02