Ph II Taletrectinib in Pts w/ Adv or Met ROS1 Positive NSCLC & Other Solid Tumors

Cancer
Misako Nagasaka
A Single-Arm, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients with Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors
Lung

Study Description

This is a global Phase 2, multicenter, single-arm, open label study of taletrectinib in patients of NSCLC harboring with ROS1 fusion gene.

119 patients will be enrolled and divided into 4 cohorts, depending on past history of ROS1 TKI treatment.

Taletrectinib will be administered 600mg once daily in 21-day cycles. Patients will continue with the study treatment until progression of disease as determined by the investigator.

The tumor response evaluation will be conducted on a regular basis until progression of disease. Long-term survival follow up will be conducted as well.

Eligibility

Eligibilities:

  • Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC or other solid tumors.
  • Evidence of ROS1 fusion in tumor tissue determined by molecular assays as performed in Clinical Laboratory Improvement Amendments (CLIA)-certified or locally equivalent laboratories.
  • Patients with central nervous system (CNS) involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously treated and controlled, are allowed; the use of seizure prophylaxis is allowed as long as patients are taking non enzyme inducing anti-epileptic drugs (non-EIAEDs). If corticosteroid treatment is required, it should be on stable or decreasing dose of ≤10 mg prednisone or equivalent. If patients have neurological symptoms or signs due to CNS metastasis, patients need to complete whole brain radiation or gamma knife irradiation treatment at least 14 days before enrollment and be clinically stable.
  • The patient is either ROS1 TKI treatment naïve, or treated with prior ROS1 TKI(s).

Exclusion:

  • Investigational agent or anticancer therapy within 2 weeks (or 5 half-lives of the compound, whichever is longer) prior to study enrollment. In addition, no concurrent anticancer therapy is permitted.
  • Previously treated with immuno-oncology (IO) including immune checkpoint inhibitors within 12 weeks before enrollment.
  • Major surgery within 4 weeks prior to enrollment.
  • Radiation therapy with a limited field for palliation within 1 week of the first dose of study treatment.
  • Toxicities due to prior therapy are unresolved to ≤ CTCAE 5.0 Grade 1 except for AEs not constituting a safety risk to the patient based on the judgment of investigators.
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