Neoplasms

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Carcinoma, Non-Small-Cell Lung

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Carcinoma, Bronchogenic

Bronchial Neoplasms

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Lung Diseases

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Amino Acids

Osimertinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

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Tyrosine

TY-9591 (160mg orally, once daily) plus placebo Osimertinib (80mg orally, once daily), in accordance with the randomization schedule.

Osimertinib (80mg orally, once daily) plus placebo TY-9591 (160mg orally, once daily), in accordance with the randomization schedule.

The dose of TY-9591 is 160 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment.

Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

TY-9591

The dose of placebo Osimertinib is 80 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment.

Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

placebo Osimertinib

The dose of Osimertinib is 80 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment.

Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

The dose of placebo TY-9591 is 160 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment.

Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

placebo TY-9591

Baohui Han, MD

Lin Wu, MD

To assess the efficacy and safety of TY-9591 versus Osimertinib in patients with locally advanced or Metastatic Non Small Cell Lung Cancer.

This is a Phase III, double-blind, randomised study assessing the efficacy and safety of TY-9591 versus Osimertinib in patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) that is known to be EGFR sensitising mutation (EGFRm) positive, treatment-naïve and eligible for first-line treatment with an EGFR-TKI.

Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)

A Phase III, Randomised, Double-blind, Multi-center Study to Assess the Efficacy and Safety of TY-9591 Tablets Versus Osimertinib as First Line Treatment in Patients With EGFR-sensitive Mutation, Locally Advanced or Metastatic Non Small Cell Lung Cancer.

PFS is defined as time from randomization until the date of first documented disease progression or death due to any cause

ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) during the study treatment

iORR is defined as the proportion of patients with a best intracranial response of complete response (CR) or partial response (PR) during the study treatment

iPFS is defined as time from randomization until the date of first documented intracranial disease progression or death due to any cause

DoR is defined as the time from the date of first documented response (PR or CR) until the date of first documented disease progression or death due to any cause during the study treatment

DCR is defined as the proportion of patients with a best overall response of complete response (CR) , partial response (PR) or Stable disease (SD) ≥6 weeks during the study treatment

CBR is defined as the proportion of patients with a best overall response of complete response (CR) , partial response (PR) or Stable disease (SD) ≥24 weeks during the study treatment

The Depth of response was defined as the relative change in the sum of the longest diameters of Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions (TLs) at the nadir compared to baseline, in the absence of new lesions (NLs) or progression of Non-target lesions (NTLs)

TTP is defined as the time from randomization until the date of first documented disease progression (excluding death)

OS is defined as the time from randomization until death from any cause

Change in FACT-L scores relative to Baseline

Adverse events, clinical symptoms, vital signs, ECG's, clinical laboratory safety tests, ect.

To characterise the pharmacokinetics (PK) of TY-9591

To characterise the pharmacokinetics (PK) of TY-9591 metabolite D1

To characterise the pharmacokinetics (PK) of TY-9591 metabolite D2

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)	NCT05382728	NSCLC EGFR Activating...	TY-9591 placebo Osimert... Osimertinib placebo TY-9591	18 Years - 80 Years	TYK Medicines, Inc
Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)	NCT05382728	NSCLC EGFR Activating...	TY-9591 placebo Osimert... Osimertinib placebo TY-9591	18 Years - 80 Years	TYK Medicines, Inc

Spots Global Cancer Trial Database for placebo osimertinib