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

NCT06672068 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

TY-9591 80mg QD+pemetrexed+Cisplatin/Carboplatin

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

DRUG

TY-9591 160mg QD+pemetrexed+Cisplatin/Carboplatin

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

Sponsors & Collaborators

  • TYK Medicines, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-20
Primary Completion
2027-12-01
Completion
2028-12-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06672068 on ClinicalTrials.gov