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
| NCT ID | NCT07416994 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | MediLink Therapeutics (Suzhou) Co., Ltd. |
| Condition | Non-Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2026-03-18 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 440 participants in total. It began in 2026-03-18 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07416994 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non-Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07416994 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 440 participants.
Is NCT07416994 currently recruiting?
Yes, NCT07416994 is actively recruiting participants. Contact the research team at clinicaltrials@medilinkthera.com for enrollment information.
Where is the NCT07416994 trial being conducted?
This trial is being conducted at Shanghai, China, Hangzhou, China.
Who is sponsoring the NCT07416994 clinical trial?
NCT07416994 is sponsored by MediLink Therapeutics (Suzhou) Co., Ltd.. The trial plans to enroll 440 participants.
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