Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
An Open-Label, Multi-Cohort, Multi-center, Non-Randomized, Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer
The objective of this study is to assess the efficacy, safety of MRG003 as single agent in EGFR-positive advanced non-small cell lung cancer
Status | Recruiting |
Enrollment | 90 |
Est. completion date | February 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Willing to sign the ICF and follow the requirements specified in the protocol. - Age: =18 years,both genders. - Expected survival time=6 months. - Patients with histologically confirmed advanced non-small cell lung cancer, and without histologically confirmed small cell lung cancer (SCLC). - Positive EGFR expression in tumor specimen. - Failed in the prior second-line or above standard of care therapies. - Archival or biopsy tumor specimens should be provided. - Patients must have measurable lesions according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). - ECOG performance score 0 or 1. - AEs related to prior systemic chemotherapy and radical/extensive radiotherapy have recovered to = Grade 1 based on National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE V5.0). - No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) = 50%. - Organ functions and coagulation function must meet the basic requirements. - Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment. Exclusion Criteria: - History of hypersensitivity to any component of the investigational product. - No documented progression after prior treatment, or recurrence during or after prior treatment. - Received radiotherapy, chemotherapy, biologicals, immunotherapy or other anti-tumor drugs within 4 weeks prior to the first dose of study treatment. - Presence of central nervous system metastasis. - Patients with significant clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage prior to the first dose of study drug. - Any severe or uncontrolled systemic disease judged by the investigator. - Patients with poorly controlled heart diseases. - Evidence of active infections, including Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) infection. - Active bacterial, viral, fungal, rickettsial, or parasitic infection requiring systemic therapy. - Prior history of other primary malignancies. - History of the following ophthalmologic abnormalities: severve dry eye syndrome; keratoconjunctivitis sicca; severe exposure keratitis; any other condition that may increase the risk of corneal epithelial damage. - History of severe skin disease requiring interruption of previous EGFR targeted therapy; or chronic skin disease requiring oral or intravenous therapy. - History of interstitial lung disease (ILD) or pneumonitis, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc. - Pulmonary radiotherapy > 30 Gy within 6 months prior to first dose of study drug. - Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug. - Patients with active autoimmune disease or history of autoimmune disease, who are using immunosuppressive agents or systemic hormone therapy and still receiving within 2 weeks prior to enrollment. - History of allogeneic tissue or solid organ transplant. - Female patients with a positive serum pregnancy test or who are breast feeding or do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment. - Active uncontrolled concomitant diseases that might limit patient's compliance with study requirements, or compromise patient's ability to provide written informed consent. - Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator. |
Country | Name | City | State |
---|---|---|---|
China | Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Shanghai Miracogen Inc. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate (ORR) by Investigator | ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to RECIST v1.1. | Baseline to study completion, up to 12 months | |
Secondary | Progression Free Survival (PFS) | PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause. | Baseline to study completion, up to 12 months | |
Secondary | Duration of Response (DoR) | DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause. | Baseline to study completion, up to 12 months | |
Secondary | Time to Response (TTR) | TTR is defined as the duration from the start of treatment to the first onset of CR or PR in tumor evaluation. | Baseline to study completion, up to 12 months | |
Secondary | Disease Control Rate (DCR) | DCR is defined as the proportions of patients achieving CR, PR, and stable disease (SD) after treatment. | Baseline to study completion, up to 12 months | |
Secondary | Overall Survival (OS) | OS is defined as the duration from the start of treatment to death of any cause. | Baseline to study completion, up to 12 months | |
Secondary | Adverse Events (AEs) | Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug. | Baseline to 60 days after the last dose of study treatment |
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