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

NCT05382728 | Recruiting Phase 3 DMC

• 1 other identifier: TYKM1601301
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

NSCLC; EGFR Activating Mutation

Outcome Measures

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

  approximately 18 months

Secondary Outcomes (14)

• Objective Response Rate (ORR)

  approximately 18 months

• Intracranial Overall Response Rate (iORR)

  approximately 18 months

• Intracranial Median Progression Free Survival (iPFS)

  approximately 18 months

• Duration of Response (DoR)

  approximately 18 months

• Disease Control Rate (DCR)

  approximately 18 months

Study Arms (2)

TY-9591+placebo Osimertinib

EXPERIMENTAL

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

Drug: TY-9591; Drug: placebo Osimertinib

Osimertinib+placebo TY-9591

ACTIVE COMPARATOR

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

Drug: Osimertinib; Drug: placebo TY-9591

Interventions

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.

Also known as: TY-9591 Tablets

TY-9591+placebo Osimertinib

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.

Also known as: placebo Tagrisso

TY-9591+placebo Osimertinib

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.

Also known as: Tagrisso

Osimertinib+placebo TY-9591

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.

Also known as: placebo TY-9591 Tablets

Osimertinib+placebo TY-9591

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
• The ECOG score is 0-1, and there is no deterioration 2 weeks before the study, and the expected survival is not less than 3 months.
• Adequate bone marrow reserve function, and no liver, kidney and coagulation dysfunction.
• Male patients and female patients of reproductive age should take adequate contraceptive measures from signing informed consent to 3 months after the last study drug treatment; Women of childbearing age have negative pregnancy test results within 7 days of the first dose.
• Patients having recovered from all grade ≤ 1 toxicities related to previous anticancer therapies (CTCAE v 5.0) except for alopecia, platinum-therapy-related neuropathy (where ≤2 is allowed) before first dose of study treatment.
• Patients can understand and voluntarily sign the informed consent form.
• Patient able to comply with study requirements.

You may not qualify if:

• Any of the following treatment:
• 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;
• Uncontrollable or poorly controlled pleural and abdominal effusion;
• Major surgery within 28 days of the first dose of study treatment;
• Patients currently receiving (or at least within 14 days prior to receiving the first dose )medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 isoenzyme (CYP)3A4;
• Patients who are receiving and need to continue receiving medications during the study that are known to prolong the QTc interval or may cause tachycardia;
• Participants in other clinical trials (other than non-interventional clinical trials) within 28 days prior to the first administration of the investigational drug.
• Pathologically confirmed squamous cell carcinoma or squamous cell component predominance in NSCLC.
• Symptomatic brain metastases or leptomeningeal metastases.
• Patients have spinal cord compression caused by tumor.
• Clinically severe gastrointestinal dysfunction may affect the ingestion, transport or absorption of the study drugs.
• Cardiac function and disease are consistent with the following:

Sponsors & Collaborators

• TYK Medicines, Inc: lead

Study Sites (2)

Hunan Provincial Tumor Hospital

Changsha, Hunan, 410013, China

RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 201203, China

RECRUITING

MeSH Terms

Interventions

osimertinib

Study Officials

• Baohui Han, MD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

• Lin Wu, MD

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baohui Han, MD

CONTACT

18930858216; 18930858216@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: June 8, 2022
• Primary Completion: May 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

CN (2)