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Recruiting NCT07416994

Pivotal Study to Evaluate YL202 Versus Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer

Phase III Interventional Non-Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: YL202, Docetaxel.
Who it may be relevant to
Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Randomized, Open-label, Phase III Study to Compare the Efficacy and Safety of YL202 and Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer

Overview

Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to evaluate YL202 monotherapy versus Docetaxel in participants with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy and platinum-based chemotherapy.

Interventions

  • Drug YL202
    Participants will receive YL202 at dose 2.0mg/kg by intravenous infusion, on Day 1 of each 3-week cycle;
  • Drug Docetaxel
    Participants will receive Docetaxel at dose 75mg/m2 by intravenous infusion, on Day 1 of each 3-week cycle;

Primary outcome measures

  • Overall Survival (OS) [Time frame: Up to Approximately 36 Months]
  • Title: Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) [Time frame: Up to Approximately 36 Months]
Secondary outcome measures (3)
  • Progression-Free Survival assessed by Investigator [Time frame: Up to Approximately 36 Months]
  • Overall response rate（ORR）assessed by BICR [Time frame: Up to Approximately 36 Months]
  • Characterize Pharmacokinetics parameter Ctrouph trough concentration [Time frame: Up to Approximately 12 Months]

Eligibility criteria

Inclusion criteria

  • Males or females aged ≥18 to ≤75 years at the time of signing the ICF
  • Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation.
  • Received one prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the locally advanced, or metastatic setting, either as monotherapy or in combination with other agents; Received one prior platinum based chemotherapy in the locally advanced, or metastatic setting, either prior to TKI, in combination with TKI, or after TKI therapy.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  • At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated.
  • Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment.
  • Current, historical, or suspected interstitial lung disease (ILD)/pneumonitis.

Exclusion criteria

  • Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%;
  • Other malignancies within 5 years prior to the first dose;
  • History of (noninfectious) interstitial lung disease (ILD) and current ILD
  • Prior HER3-targeted therapy; Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs);
  • Pregnant or lactating women;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Shanghai Dongfang Hospital — Shanghai
  • Zhejiang Provincial Cancer — Hangzhou

Identifiers

NCT: NCT07416994 · YL202-CN-301-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗