Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YL202 | Experimental |
| |
| Docetaxel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YL202 | Drug | Participants will receive YL202 at dose 2.0mg/kg by intravenous infusion, on Day 1 of each 3-week cycle; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from randomization to the event of death from any cause. | Up to Approximately 36 Months |
| Title: Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) | 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. | Up to Approximately 36 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival assessed by Investigator | PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by investigator or death from any cause, whichever occurs earlier. | Up to Approximately 36 Months |
| Overall response rate(ORR)assessed by BICR |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medilink Study Team | Contact | +86 0512-62858368 | clinicaltrials@medilinkthera.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Dongfang Hospital | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Docetaxel | Drug | Participants will receive Docetaxel at dose 75mg/m2 by intravenous infusion, on Day 1 of each 3-week cycle; |
|
ORR is defined as participants achieving a best overall response of confirmed Complete response (CR) or confirmed partial response (PR) per BICR based on RECIST version 1.1. |
| Up to Approximately 36 Months |
| Characterize Pharmacokinetics parameter Ctrouph trough concentration | Serum drug concentration (including ADC, total antibody [TAb], and unconjugated payload) | Up to Approximately 12 Months |
| Zhejiang Provincial Cancer | Recruiting | Hangzhou | Zhejiang | 310022 | China |
|
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided