Pivotal Study to Evaluate YL202 Versus Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer
YL202: Participants will receive YL202 at dose 2.0mg/kg by intravenous infusion, on Day 1 of each 3-week cycle;
Docetaxel: Participants will receive Docetaxel at dose 75mg/m2 by intravenous infusion, on Day 1 of each 3-week cycle;
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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;
Primary outcome measure(s)
Overall Survival (OS) — Up to Approximately 36 Months OS is defined as the time from randomization to the event of death from any cause.
Title: Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) — Up to Approximately 36 Months PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by BICR or death from any cause, whichever occurs earlier.
Trial sites (2)
Facility
City
Region
Status
Shanghai Dongfang Hospital
Shanghai
Shanghai Municipality
Recruiting
Zhejiang Provincial Cancer
Hangzhou
Zhejiang
Recruiting
More MediLink Therapeutics (Suzhou) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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