Study of PD-1 Antibody and PARP Inhibitor in Extensive Stage Small Cell Lung Cancer
Not Applicable
- Conditions
- Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT04782089
- Lead Sponsor
- Qilu Hospital of Shandong University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- 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 ；
- 18-75 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；
Exclusion Criteria
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Camrelizumab+Fluzoparib Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitors -
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) Approximately 3 years To assess the efficacy of Camrelizumab and Fluzoparib combination therapy in terms of PFS
- Secondary Outcome Measures
Name Time Method