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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
440
Shanghai Dongfang Hospital
Shanghai, Shanghai Municipality, China
Zhejiang Provincial Cancer
Hangzhou, Zhejiang, China
Overall Survival (OS)
OS is defined as the time from randomization to the event of death from any cause.
Time frame: 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.
Time frame: Up to Approximately 36 Months
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.
Time frame: Up to Approximately 36 Months
Overall response rate(ORR)assessed by BICR
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.
Time frame: Up to Approximately 36 Months
Characterize Pharmacokinetics parameter Ctrouph trough concentration
Serum drug concentration (including ADC, total antibody \[TAb\], and unconjugated payload)
Time frame: Up to Approximately 12 Months
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