A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT04311034|
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : March 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: RC48||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||September 26, 2018|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||December 30, 2021|
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.
- Objective Response Rate （ORR） [ Time Frame: 15 months ]Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).
- Disease Control Rate (DCR) [ Time Frame: 15 months ]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.
- Progression Free Survival (PFS) [ Time Frame: 15 months ]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.
- Duration of Response (DOR) [ Time Frame: 15 months ]Duration of response is the length of time that a tumor continues to respond to treatment without the cancer growing or spreading.
- Overall Survival (OS) [ Time Frame: 24 months ]Overall survival, or OS, measures how long patients, who undergo a certain treatment regimen.
- Adverse events (AEs) [ Time Frame: Up to 2 years ]The drug safety was assessed by investigator(s) according to NCI-CTCAE v4.03.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04311034
|Contact: Jianmin Fangemail@example.com|
|Shanghai Pulmonary Hospital||Recruiting|
|Shanghai, Shanghai, China, 200433|
|Contact: Caicun Zhou, M.D.|