YL202 Compared With Docetaxel for EGFR-Mutated Non-Small Cell Lung Cancer
Compares YL202 with docetaxel in adults whose EGFR-mutated lung cancer progressed after treatment.
Key facts
- Who runs it
- MediLink Therapeutics (Suzhou) Co., Ltd.
- Where
- Hangzhou and Shanghai, ChinaSee the 2 sites
- Trial code
- Registry title
- Pivotal Study to Evaluate YL202 Versus Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 440 people, planned
- Started
- 18 Mar 2026
- Expected to end
- 31 Aug 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- YL202
- Docetaxel
- Record updated
- 15 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic non-squamous non-small cell lung cancer with an EGFR mutation, whose cancer kept growing after an EGFR-TKI and platinum-based chemotherapy.
- Age
- 18 to 75 years
- Sex
- Men and women can join.
- Disease stage
- Locally advanced or metastatic non-squamous non-small cell lung cancer, with at least 1 measurable tumour that has not been irradiated before. ECOG performance status 0 to 1. Brain metastases must cause no symptoms or be stable after treatment.
- Earlier treatment
- Must have had one earlier EGFR tyrosine kinase inhibitor (EGFR TKI) and one earlier platinum-based chemotherapy. Cannot have had earlier HER3-targeted therapy or any topoisomerase I inhibitor drug, including antibody-drug conjugates (ADCs).
- Biomarker or test result
- EGFR Exon 19 deletion or Exon 21 L858R mutation.
Main reasons for not taking part
- Small cell lung cancer, neuroendocrine carcinoma, carcinosarcoma, or more than 10% squamous cell carcinoma components
- Another cancer within 5 years before the first dose
- Past or current interstitial lung disease (ILD)
- Earlier HER3-targeted therapy or topoisomerase I inhibitor therapy, including ADCs
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Other malignancies within 5 years prior to the first dose
- Prior HER3-targeted therapy; Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs)
- Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%
- History of (noninfectious) interstitial lung disease (ILD) and current ILD
- Pregnant or lactating women
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Zhejiang Provincial CancerHangzhou, ChinaContact: Study coordinatorTaking people
- Shanghai Dongfang HospitalShanghai, ChinaContact: study coordinatorTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- YL202Treatment being tested
- DocetaxelExisting treatment, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- YL202 Compared With Docetaxel for EGFR-Mutated Non-Small Cell Lung CancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07416994, who can take part
- Record updated
- 15 June 2026