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Report for Clinical Trial NCT04311034

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase Ib Study to 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

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.

NCT04311034 Non Small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: RC48

Description: Participants will be treated with RC48-ADC at a dose of 2.0 mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, investigators believed that the subject could no longer benefit from treatment, or this study ended.
Type: Drug
Group Labels: 1

RC48


Primary Outcomes

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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: Overall survival, or OS, measures how long patients, who undergo a certain treatment regimen.

Measure: Overall Survival (OS)

Time: 24 months

Secondary Outcomes

Description: The drug safety was assessed by investigator(s) according to NCI-CTCAE v4.03.

Measure: Adverse events (AEs)

Time: Up to 2 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T790M

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 ---



HPO Nodes


HPO: