🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07416994
Recruiting Phase 3

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

NCT07416994 · tracked via the Priya Life Science China tracker
Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Phase
Phase 3
Started
2026-03-18
Last updated
2026-06-15

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

YL202 →Docetaxel →

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

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Males or females aged ≥18 to ≤75 years at the time of signing the ICF 2. 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. 3. 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. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. 5. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated. 6. Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment. 7. Current, historical, or suspected interstitial lung disease (ILD)/pneumonitis. Exclusion Criteria: 1. Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%; 2. Other malignancies within 5 years prior to the first dose; 3. History of (noninfectious) interstitial lung disease (ILD) and current ILD 4. Prior HER3-targeted therapy; Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs); 5. Pregnant or lactating women;

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Shanghai Dongfang Hospital Shanghai Shanghai Municipality Recruiting
Zhejiang Provincial Cancer Hangzhou Zhejiang Recruiting

More MediLink Therapeutics (Suzhou) Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07416994 on ClinicalTrials.gov ↗ ← All trials in China