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

ConditionsNSCLCEGFR Activating Mutation
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • TY-9591

    Drug

    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.

  • placebo Osimertinib

    Drug

    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.

  • Osimertinib

    Drug

    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.

  • placebo TY-9591

    Drug

    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.

Treatment groups

680 Participants
are divided into 2 treatment groups
Group A: TY-9591+placebo OsimertinibExperimental treatment 2 interventions
Group B: Osimertinib+placebo TY-9591Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Median Progression Free Survival (PFS)

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

Time frame
approximately 18 months

Secondary outcomes

1

Objective Response Rate (ORR)

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

Time frame
approximately 18 months
2

Intracranial Overall Response Rate (iORR)

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

Time frame
approximately 18 months
3

Intracranial Median Progression Free Survival (iPFS)

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

Time frame
approximately 18 months
4

Duration of Response (DoR)

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

Time frame
approximately 18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TYK Medicines, Inc

Lead sponsor

Source ClinicalTrials.gov
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