2023 World Conference on Lung Cancer (Posters)-P2.17. CAN: A Phase II Trial of Combination of Niraparib and Anlotinib in Patients with Recurrent Small Cell Lung Cancer

P2.17. CAN: A Phase II Trial of Combination of Niraparib and Anlotinib in Patients with Recurrent Small Cell Lung Cancer - PDF(Slides)

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A Phase II trial was conducted to evaluate the combination of niraparib and anlotinib in patients with recurrent small cell lung cancer (rSCLC). The study enrolled 25 patients with a median age of 63, and the median follow-up was 7.57 months. Among the 20 evaluable patients, the confirmed objective response rate (ORR) was 20%, with 4 partial responses (PR) and 4 stable diseases (SD). There were 2 unconfirmed PR due to COVID-19 pandemic and safety intolerance. The duration of response (DOR) was 4.3 months. The median progression-free survival (PFS) was 7.06 months, and the median overall survival (OS) was not reached. The incidence of any grade treatment-emergent adverse events (TEAEs) was 72%, with the most common being hypertriglyceridemia and anemia. Grade 3 AE was 44%, and serious adverse event rate was 20%.<br /><br />The combination of niraparib and anlotinib showed promising efficacy and good tolerance in rSCLC patients, with a median PFS of 7.06 months. The study is still ongoing in the second stage. These results suggest that the synergistic effects of VEGF-targeted therapy and PARP inhibitors in SCLC warrant further investigation. SCLC accounts for 13-15% of all lung cancers and has a poor prognosis despite the approval of immunotherapy. The median PFS with current treatments is around 5.2 months. Preclinical studies have shown that VEGF-targeted therapy and PARP inhibitors have synergistic effects in killing tumor cells.<br /><br />The CAN study is a prospective, open-label, single-arm phase II trial aiming to investigate the efficacy and safety of niraparib in combination with anlotinib in recurrent SCLC patients. The study design was presented at the 2022 WCLC conference, and this report presents the preliminary efficacy and safety data. The primary endpoint is ORR, and secondary endpoints include PFS, OS, and safety. The study will enroll up to 62 patients with a Simon's two-stage design. In the first stage, 19 patients will be enrolled, and if there are 3 responses, the study will continue with 42 patients in the second stage. The study also aims to explore efficacy-related biomarkers.

Asset Subtitle

Ying Cheng

Meta Tag

Speaker Ying Cheng

Topic SCLC & Neuroendocrine Tumors: Relapse & Salvage Therapy

Keywords

niraparib

anlotinib

recurrent small cell lung cancer

phase II trial

objective response rate

partial response

stable disease

COVID-19 pandemic

progression-free survival

overall survival