2024 World Conference on Lung Cancer (WCLC) - Posters-P2.10A.05 Ipat-Lung: A Multi-Center Phase 2 Study of Ipatasertib Plus Docetaxel in NSCLC Patients who Have Failed or Are Intolerant to 1st Line Immunotherapy

P2.10A.05 Ipat-Lung: A Multi-Center Phase 2 Study of Ipatasertib Plus Docetaxel in NSCLC Patients who Have Failed or Are Intolerant to 1st Line Immunotherapy

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Pdf Summary

The "Ipat-Lung" study is a multi-center phase II clinical trial evaluating the combination of ipatasertib, an AKT1 inhibitor, and docetaxel in patients with non-small cell lung cancer (NSCLC) who have not benefited from or cannot tolerate first-line immunotherapy. Conducted by Jun Zhang and colleagues, this trial targets patients with advanced or metastatic NSCLC who have exhausted primary treatment options, including immunotherapy and chemotherapy, without achieving desirable outcomes.<br /><br />The rationale behind the study is the frequent occurrence of aberrations in the PI3K-AKT pathway in NSCLC patients, which contributes to tumor survival and an immunosuppressive microenvironment. Previous studies have shown that combining ipatasertib with taxanes is both safe and effective. Participants in this trial receive ipatasertib orally alongside docetaxel in 21-day cycles, supported by G-CSF to mitigate neutropenia.<br /><br />The trial's main goal is to assess progression-free survival (PFS), hypothesizing that this treatment could extend median PFS by 50% compared to existing benchmarks. Secondary objectives include evaluating overall survival (OS), the objective response rate (ORR), and treatment safety. Exploratory endpoints aim to correlate PFS with biological markers like cfDNA and PTEN status.<br /><br />The trial plans to enroll 60 participants, allowing for a 25% dropout rate, to achieve significant statistical power. This study is financially supported by Genentech, and it remains in progress. The findings could potentially offer new therapeutic avenues for NSCLC patients resistant or intolerant to first-line treatments, expanding options for improved management of the disease.

Asset Subtitle

Jun Zhang

Meta Tag

Speaker Jun Zhang

Topic Metastatic NSCLC – Cytotoxic Therapy

Keywords

Ipat-Lung study

phase II clinical trial

ipatasertib

AKT1 inhibitor

docetaxel

non-small cell lung cancer

PI3K-AKT pathway

progression-free survival

immunotherapy resistance

Genentech