This study will evaluate the efficacy and safety of RC48-ADC for injection in subjects with advanced non-small cell lung cancer with HER2 overexpression or HER2 mutation.
Name: RC48
Description: Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).
Measure: Objective Response Rate (ORR) Time: 15 monthsDescription: Disease Control Rate (DCR) was defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents.
Measure: Disease Control Rate (DCR) Time: 15 monthsDescription: Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measure: Progression Free Survival (PFS) Time: 15 monthsDescription: Duration of response is the length of time that a tumor continues to respond to treatment without the cancer growing or spreading.
Measure: Duration of Response (DOR) Time: 15 monthsDescription: Overall survival, or OS, measures how long patients, who undergo a certain treatment regimen.
Measure: Overall Survival (OS) Time: 24 monthsDescription: The drug safety was assessed by investigator(s) according to NCI-CTCAE v4.03.
Measure: Adverse events (AEs) Time: Up to 2 yearsAllocation: N/A
Single Group Assignment
There is one SNP
For EGFR gene mutation-positive patients, one of the following is met: 1) T790M gene mutation negative, c-Met gene amplification negative and HER2 IHC 2+ or 3+ after first-generation EGFR-TKI drug resistance; 2) Third-generation EGFR-TKI treatment failed and HER2 IHC 2+ or 3+. 9. Measurable lesion according to the RECIST 1.1. --- T790M ---