521P - Camrelizumab combined with chemotherapy and apatinib as first-line therapy for extensive-stage small cell lung cancer: A phase II, single-arm, exploratory research

Background

Extensive-stage small-cell lung cancer (ES-SCLC) is an aggressive tumor type with limited therapeutic options and poor prognosis. It is worthy to explore the new treatment pattern in consideration of the rapid disease progression. Therefore, this study aims to explore the effectiveness and safety of camrelizumab combined with chemotherapy and apatinib in the first-line treatment of ES-SCLC.

Methods

In this phase II study, 40 patients with pathological diagnosis of ES-SCLC and without receiving prior systemetic therapy are anticipated to be enrolled, and will be dosed camrelizumab (200 mg, q3w) combined with etoposide (80-100 mg/m², q3w, 4-6 cycles) and platinum drugs (selected by the researcher according to the patients, q3w, 4-6 cycles), followed by maintenance with camrelizumab and apatinib (250 mg, qd). The primary endpoint is 6-month progress-free survival (6-month PFS) rate while the secondary endpoints are objective response rate (ORR), disease control rate (DCR), progression-free survival, overall survival and safety.

Results

Up to August 20, 2023, 24 patients with a median age of 59 years (ranged from 38 to 75 years) were enrolled. All patients were capable for efficacy analysis, of which 21 patients achieved partial response, 1 had stable disease and 2 progressive disease. The 6-month PFS rate in evaluable patients was 58.82% (10/17). The ORR and DCR were 87.50% and 91.67%, respectively. During the course of therapy, most common grade 3 or worse treatment-related adverse events were increased AST level (4.17%), increased ALT level (4.17%), increased γ-GT (4.17%), hypertension (4.17%) and hypetriglyceridemia (4.17%). Common grade 1-2 adverse reactions included nausea (66.67%), vomiting(66.67%), anemia(50.00%), increased γ-GT (20.83%) and proteinuria (20.83%). The treatment was well tolerated and no toxic death occurred. All the adverse events can be controlled and alleviated after symptomatic treatment.

Conclusions

The significant benefit and controllable security reflected by the camrelizumab in combination with chemotherapy and apatinib could support this combination as a new first-line treatment option for this population.

Clinical trial identification

ChiCTR2000035599.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.