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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04782089

Enrollment

Registered

2021-03-04

Start date

2021-05-06

Completion date

2024-06-01

Last updated

2021-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer

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

Interventions

DRUGCamrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitors

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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;

Design outcomes

Primary

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

Contacts

Primary ContactJisheng Li, PhD

lijisheng@sdu.edu.cn0531-82169841

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026