Study Comparing DS-1062a and Docetaxel for Advanced Non-Small Cell Lung Cancer

Program Overview

The study aims to compare a new drug, DS-1062a, with the standard chemotherapy drug, docetaxel, in patients with advanced or metastatic non-small cell lung cancer (NSCLC). It will assess how well each drug works, their safety, and how the body processes them. Participants may have specific genetic changes in their cancer or not, and must have previously received certain treatments. The study includes three phases: Screening, Treatment, and Follow-up.

Description

This study involves testing a new drug, DS-1062a, against the standard chemotherapy drug, docetaxel, in patients with advanced non-small cell lung cancer (NSCLC). Participants will be divided into two groups: those with specific genetic changes in their cancer and those without.

For those without genetic changes, participants must have already been treated with platinum-based chemotherapy and a type of immunotherapy. For those with genetic changes, participants must have tried targeted therapies specific to their cancer type and have seen their cancer progress despite treatment.

The study will be conducted in three parts:

1. Screening Period: Participants will undergo tests to determine eligibility.
2. Treatment Period: Participants will receive either DS-1062a or docetaxel.
3. Follow-up Period: Participants will be monitored for health and treatment effects.

Participants must meet specific health criteria, including having a life expectancy of at least three months, adequate organ function, and a good performance status. Women of childbearing potential must use effective birth control, and men must use condoms during and after the study to prevent pregnancy.

Eligibility Criteria

Locations