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NSCLCPhase 2NCT06672068

A Study of TY-9591 With Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor NSCLC

A Phase 2 study testing TY-9591 80mg QD+pemetrexed+Cisplatin/Carboplatin and TY-9591 160mg QD+pemetrexed+Cisplatin/Carboplatin in people with NSCLC, run by TYK Medicines, Inc.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This study was a parallel, randomized, multicenter phase II clinical trial to evaluate the efficacy and safety of TY-9591 combined with platinum-based chemotherapy as first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR sensitive mutations. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
NSCLC
What is being tested?
TY-9591 80mg QD+pemetrexed+Cisplatin/Carboplatin and TY-9591 160mg QD+pemetrexed+Cisplatin/Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
20 Feb 2025to 1 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female ≥18 years old and <80 years old.
  • Patients with non-squamous non-small cell lung cancer (NSCLC) diagnosed by histology or cytology as locally advanced (clinical stage IIIB, IIIC, no chance of radical surgery or radical chemoradiotherapy) or metastatic (clinical stage IVA, IVB) (according to the AJCC TNM staging criteria for lung cancer, 8th edition).
  • Tissue or blood samples tested positive for EGFR sensitive mutations (including exon 19 deletion, exon 21 L858R mutation, alone or in combination with other EGFR mutations) by central laboratory or research center, other tertiary hospitals, or third-party laboratories.
  • He had received no previous systemic antitumor therapy for locally advanced or metastatic non-small-cell lung cancer. Patients who had received previous adjuvant and neoadjuvant therapy and definitive radiotherapy/chemoradiotherapy were allowed if the last treatment was more than 12 months after disease recurrence or metastasis.
  • Patients had at least one measurable target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) : no previous local treatment such as radiotherapy, an accurately measurable target lesion at baseline, and a baseline maximum diameter of 10mm or more (or a short diameter of 15mm or more in the case of a lymph node). For patients with postoperative recurrence, lesions in the area of previous local treatment (radiotherapy or other therapy) were considered measurable only if disease progression occurred more than 6 months after the end of treatment.
  • With an ECOG score of 0-1 and no deterioration during the first 2 weeks of the study, survival was expected to be no less than 3 months.
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  • Patients were required to have adequate bone marrow reserve and no hepatic, renal, or coagulopathy, with laboratory values that met the following criteria (no previous blood or platelet transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) transfusion within 14 days before the first dose in this study).
  • Male patients and female patients of reproductive age should take adequate contraceptive measures within 3 months after signing the study informed consent to the last study drug treatment; In women of childbearing age, the blood pregnancy test results were negative within 7 days before the first dose.
  • Before the first dose of study drug, all toxic effects (except alopecia and grade 2 neurotoxicity related to prior platinum-based chemotherapy) associated with previous systemic therapy (e.g., adjuvant chemotherapy) had been resolved (to grade 1 or less).

Who cannot join

  • The following treatments exist for patients:
  • Previous treatment with any EGFR-TKI was performed.
  • Previous systemic anti-tumor therapy for advanced/metastatic non-small cell lung cancer (including chemotherapy, targeted therapy, biological therapy, immunotherapy, etc.), neoadjuvant and adjuvant therapy, definitive radiotherapy/chemoradiotherapy were eligible according to the inclusion criteria
  • Anti-tumor therapy with traditional Chinese medicine with anti-tumor indications was received within 7 days before the first dose of the study drug.
  • Prior whole brain radiotherapy (WBRT); Received >30% bone marrow or extensive radiation within 28 days before the first dose of study drug; Local radiotherapy or palliative radiotherapy for bone metastases had been administered within 7 days before the first dose of study drug.
  • Uncontrolled or poorly controlled pleural effusion and pericardial effusion.
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  • Patients with other malignancies or a history of other malignancies were excluded if they had malignancies that had been treated with curative intent, had no known active disease for more than 5 years before the first dose of study treatment, and had a low potential risk of recurrence; Cured basal cell or squamous cell carcinoma of the skin, papillary carcinoma of the thyroid, carcinoma in situ of the cervix and ductal carcinoma in situ of the breast.
  • rimary malignant brain tumors or unstable brain metastases. Unstable brain metastases were defined as patients with CNS complications requiring urgent neurosurgical treatment (e.g., surgery); Patients requiring glucocorticoids, mannitol, or diuretics with a dose of more than 5mg dexamethasone equivalent for the control of symptoms of brain metastases within 14 days before the first dose; Patients who received local radiotherapy or gamma knife treatment or other local CNS treatment (e.g., intrathecal chemotherapy) within 14 days before the first study dose; Patients with meningeal metastases were not enrolled.
  • The patient had symptoms of spinal cord compression caused by the tumor.
  • Uncontrollable cancer pain; Stable doses of narcotic painkillers were not achieved at enrollment.
  • Clinically significant gastrointestinal abnormalities that may affect the intake, transport, or absorption of the study drug, such as inability to take drugs orally, uncontrollable nausea or vomiting, history of large gastrointestinal resection, Uncured recurrent diarrhea, atrophic gastritis (onset age less than 60 years), uncured gastric diseases requiring long-term use of ppis, Crohn's disease, and ulcerative colitis.
  • A previous or screening history of interstitial lung disease or interstitial pneumonia (ILD), or drug-induced ILD, or radiation pneumonitis requiring hormonal therapy, or the presence of any evidence of active ILD (e.g., acute onset or progressive pneumonitis/pulmonary fibrosis at baseline) Or pulmonary symptoms that were considered by the investigator to be ineligible for enrollment or factors that were judged to be at high risk for the development of interstitial lung disease.
  • Had previously received an allogeneic bone marrow transplant.
  • Pregnant and lactating women.
  • Known or suspected allergy to test drug ingredients or their analogues.

About this study

Official title: To Evaluate the Efficacy and Safety of TY-9591 Tablets Combined With Chemotherapy as First-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation

This study was a parallel, randomized, multicenter phase II clinical trial to evaluate the efficacy and safety of TY-9591 combined with platinum-based chemotherapy as first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR sensitive mutations.

Read the detailed description

Participants were randomly assigned in a 1:1 ratio to either cohort 1 or cohort 2 for 21-day treatment cycles until disease progression (RECIST v1.1 criteria), treatment discontinuation criteria, withdrawal criteria, or study discontinuation, whichever occurred first. After the subjects terminate or withdraw from this study, the investigators can use reasonable follow-up treatment according to the subjects' condition.

Conditions
NSCLC
Being tested
TY-9591 80mg QD+pemetrexed+Cisplatin/Carboplatin, TY-9591 160mg QD+pemetrexed+Cisplatin/Carboplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TY-9591 80mg QD+pemetrexed+Cisplatin/CarboplatinDrug

    Also called TY-9591 +pemetrexed+Cisplatin/Carboplatin

    TY-9591 80mg QD+pemetrexed 500mg/m²（D1，Q3w）+Carboplatin AUC5/ Cisplatin 75mg/m²（D1，Q3w*4 cycles）

  • TY-9591 160mg QD+pemetrexed+Cisplatin/CarboplatinDrug

    Also called TY-9591+pemetrexed+Cisplatin/Carboplatin

    TY-9591 160mg QD+pemetrexed 500mg/m²（D1，Q3w）+Carboplatin AUC5/ Cisplatin 75mg/m²（D1，Q3w*4 cycles）

Study groups in NCT06672068
Study groupRoleWhat they receive
Cohort 1ExperimentalTY-9591 80mg QD+pemetrexed 500mg/m²（D1，Q3w）+Carboplatin AUC5/ Cisplatin 75mg/m²（D1，Q3w*4 cycles）
Receives: Drug: TY-9591 80mg QD+pemetrexed+Cisplatin/Carboplatin
Cohort 2ExperimentalTY-9591 160mg QD+pemetrexed 500mg/m²（D1，Q3w）+Carboplatin AUC5/ Cisplatin 75mg/m²（D1，Q3w*4 cycles）
Receives: Drug: TY-9591 160mg QD+pemetrexed+Cisplatin/Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Defined as the proportion of subjects with an optimal response of CR or PR observed throughout the study from the start of randomization until first disease progression

    Measured: Up to 33 months

Secondary outcomes (4)

  1. PFS

    It was defined as the time from the start of randomization to the first occurrence of disease progression or death from any cause, whichever occurred first

    Measured: Up to 45 months

  2. DoR

    It was defined as the time during study treatment from the first assessment of a tumor as CR or PR to the first assessment of PD or death from any cause, whichever occurred first

    Measured: Up to 45 months

  3. DCR

    The optimal response observed throughout the study from randomization to first disease progression was the proportion of subjects with CR or PR or SD (duration ≥6 weeks)

    Measured: Up to 33 months

  4. OS

    It was defined as the time from the start of randomization to death from any cause

    Measured: Up to 45 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2024
  2. Study start20 Feb 2025 (estimated)
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06672068
Sponsor's protocol ID
TYKM1601203
Status last verified
Nov 2024
First submitted
1 Nov 2024
Last updated
30 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TY-9591 80mg QD+pemetrexed+Cisplatin/Carboplatin and TY-9591 160mg QD+pemetrexed+Cisplatin/Carboplatin in people with NSCLC, run by TYK Medicines, Inc.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: Up to 33 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06672068.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.

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