2023 World Conference on Lung Cancer (Posters)-P2.12. Phase II Trial of LP-300 + Pemetrexed/Carboplatin in Patients Who Never Smoked with Lung Adenocarcinoma After TKI Progression

P2.12. Phase II Trial of LP-300 + Pemetrexed/Carboplatin in Patients Who Never Smoked with Lung Adenocarcinoma After TKI Progression - PDF(Slides)

Back to course

Pdf Summary

A phase II clinical trial is being conducted to evaluate the efficacy and safety of LP-300, a multi-targeting modulator of oncogenes, in patients with lung adenocarcinoma who have never smoked. The trial will enroll 90 patients and involves two stages.<br /><br />The first stage is a safety lead-in stage where six patients will be treated with LP-300 and carboplatin/pemetrexed. If at least two out of three patients do not experience dose-limiting toxicities, the remaining three patients will be treated. If the dose-limiting toxicity rate is one out of six patients, the trial will proceed to the second stage. However, if two out of three or two out of six patients experience dose-limiting toxicities, the dose will be reduced.<br /><br />In the second stage, patients will be randomized to receive either LP-300 with carboplatin/pemetrexed or carboplatin/pemetrexed alone, with a 2:1 ratio. After six cycles of treatment, patients will have the option of receiving pemetrexed maintenance therapy.<br /><br />The primary objective of the trial is to evaluate progression-free survival and overall survival in patients receiving LP-300 with carboplatin/pemetrexed compared to carboplatin/pemetrexed alone. Secondary objectives include evaluating tumor response and duration of response. Exploratory objectives involve studying the association between efficacy endpoints and biomarkers or genomic characteristics of tumors.<br /><br />Inclusion criteria for the trial include patients who have never smoked, have lung adenocarcinomas with actionable genomic alterations, and have experienced disease progression or unacceptable toxicities after receiving TKIs for non-small cell lung cancer. Patients with stable brain metastases are allowed.<br /><br />Exclusion criteria include patients with certain histological types of lung cancer, prior systemic chemotherapy, a corrected QT interval longer than 470 msec, and unstable brain metastases.<br /><br />A prior Phase III study showed no overall survival benefit with LP-300 and chemotherapy in the overall patient population. However, retrospective analyses indicated that females and never-smokers derived significant benefit, suggesting that these subgroups may have oncogene-driven tumors. This phase II trial aims to prospectively validate these findings by evaluating LP-300 with carboplatin/pemetrexed in patients who have never smoked and have targetable genomic alterations after TKI progression or intolerance.

Asset Subtitle

Joseph Treat

Meta Tag

Speaker Joseph Treat

Topic Metastatic NSCLC: Targeted Therapy - Other

Keywords

phase II clinical trial

LP-300

lung adenocarcinoma

never smoked

safety lead-in stage

dose-limiting toxicities

randomized

progression-free survival

overall survival

oncogene-driven tumors