Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTYK Medicines, Inc
About this trial
To assess the efficacy and safety of TY-9591 versus Osimertinib in patients with locally advanced or Metastatic Non Small Cell Lung Cancer.
Eligibility criteria
Qualifiers
Male or female aged ≥18 years and <80 years.
Locally advanced or metastatic NSCLC diagnosed by histology or cytology.
Presence of an activating EGFR-sensitive mutations (including exon 19 deletions, L858R, the above mentioned mutations alone or co-existed with other EGFR-mutated sites).
No prior systemic antitumor therapy for locally advanced or metastatic NSCLC.
Disqualifiers
Previous treatment with EGFR inhibitor;
Previous treatment with Systematic antitumor therapy (including targeted therapy, biotherapy and immunodrug therapy, etc.)；
Previous treatment with standard chemotherapy with 28 days before the first dose of the study drug, and traditional Chinese medicine antitumor therapy within 7 days before the first dose of the study drug;
Receiving radiation to more than 30% of the bone marrow or with a wide field of radiation that had to be completed within 28 days of the first dose of study treatment; Radiotherapy with a limited field of radiation within 7 days of the first dose of study treatment or palliative radiation therapy for bone metastasis;
Trial design
Treatments tested in this trial
- TY-9591
- placebo Osimertinib
- Osimertinib
- placebo TY-9591
Treatment groups
680 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov