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

RecruitingPhase 3Ages 18 Years - 75 YearsAllMediLink Therapeutics (Suzhou) Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Males or females aged โ‰ฅ18 to โ‰ค75 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;
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What it tests

  • YL202
  • Docetaxel
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Where

2 sites
Shanghai Dongfang Hospital
Shanghai, China
Zhejiang Provincial Cancer
Hangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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