Clinical trial · Interventional
Pivotal Study to Evaluate YL202 Versus Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| YL202 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- YL202
- interventionNames
- Drug: YL202
- type
- ACTIVE_COMPARATOR
- label
- Docetaxel
- interventionNames
- Drug: Docetaxel
Primary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
- Up to Approximately 36 Months
- description
- OS is defined as the time from randomization to the event of death from any cause.
- measure
- Title: Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available