Phase 2 Global Study of Taletrectinib for ROS1 Positive Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Nuvation Bio Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04919811

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, taletrectinib, for treating advanced non-small cell lung cancer (NSCLC) in patients with a specific genetic marker called ROS1.

Patient Parameters

Program Overview

The study aims to evaluate how safe and effective taletrectinib is when used alone to treat advanced non-small cell lung cancer (NSCLC) in patients with a ROS1 fusion gene. About 224 patients will participate, divided into groups based on their previous treatments. Taletrectinib will be given in cycles, and in some cases, combined with other chemotherapy drugs. Patients will continue treatment until their cancer progresses, with regular checks to see how the tumors respond. Long-term follow-up will also be conducted to monitor survival.

Description

This global Phase 2 study involves patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic change called the ROS1 fusion gene. The study will include about 224 patients who will be divided into different groups based on their previous treatments with ROS1-targeted therapies.

Participants will receive taletrectinib, either 400mg or 600mg once daily in 21-day cycles. In one group, taletrectinib will be combined with chemotherapy drugs carboplatin and pemetrexed, given by IV infusion for four cycles. Patients will continue taking taletrectinib until their cancer shows signs of getting worse.

The study will regularly evaluate how the tumors respond to the treatment, and there will be long-term follow-up to assess survival rates. The goal is to determine if taletrectinib is a safe and effective treatment option for patients with this type of lung cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older (or 20 years as required by local regulations).
  • Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) or other solid tumors.
  • Have a ROS1 fusion gene confirmed by a specific test.
  • If the cancer has spread to the brain or spinal cord, it must be stable and controlled.
  • Can be either new to ROS1-targeted treatments or have had them before.
  • Must have at least one measurable tumor.
  • Be in good overall health with a performance status of 0 or 1.
  • Have a life expectancy of at least 12 weeks.
  • Have adequate organ function based on specific blood tests.
  • Must agree to use effective contraception during the study.
  • Be willing and able to follow the study schedule and procedures.
  • Agree to comply with the study site's COVID-19 policies.

Exclusion Criteria

  • Recent treatment with other cancer therapies or investigational drugs.
  • Major surgery or significant injury within four weeks before starting the study.
  • Recent radiation therapy, except for certain types completed at least one week before the study.
  • Have another primary cancer, except for certain non-threatening types.
  • Unresolved side effects from previous treatments.
  • Untreated spinal cord compression or cancerous meningitis.
  • History of lung diseases like fibrosis or pneumonitis.
  • Gastrointestinal disorders affecting medication absorption.
  • Active infections, including hepatitis or HIV.
  • Recent significant heart problems.
  • Ongoing heart rhythm issues or family history of long QT syndrome.
  • Pregnant or breastfeeding women.
  • Use of certain medications affecting liver enzymes or heart rhythm.
  • Other severe medical or mental health conditions that increase study risk.

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