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Compares treatment options for Non-Small Cell Lung Cancer
Official 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
ClinicalTrials.gov ID: NCT07416994
What this study is testing
What is YL202?
YL202 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Received one prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the locally advanced, or metastatic setting...
- 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.
You likely can't join if
- Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous...
- 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;
See the full eligibility 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...
- 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.
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.