YL202 vs Docetaxel in EGFR-mutated NSCLC after prior therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3 interventional study comparing YL202 monotherapy to Docetaxel in adults with EGFR-mutated, non-squamous NSCLC that is locally advanced or metastatic and has progressed after prior EGFR TKI and platinum-based chemotherapy. Participants must have measurable disease and good performance status. The study aims to determine if YL202 can improve outcomes compared with standard chemotherapy. Eligible sites are in Shanghai and Hangzhou, China, led by MediLink Therapeutics with no listed collaborators.

Why it matters

Who can join: the full rules

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;

Where it's running

• Shanghai Dongfang Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Zhejiang Provincial Cancer
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Medilink Study Team
• Email: clinicaltrials@medilinkthera.com
• Phone: +86 0512-62858368

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.