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

Shandong University

Status: Not yet enrolling

Conditions: Small Cell Lung Cancer

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04782089

ES-SCLC-2nd-IIT-SHR3162-APA

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Camrelizumab+Fluzoparib

Experimental group

Treatment:

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