EGFR-positive advanced non-small cell lung cancer (NSCLC)
Conditions
Interventions
MRG003:On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.5 mg/kg calculated based on the actual body weight (BW)
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing to sign the ICF and follow the requirements specified in the protocol; 2. Age: >= 18 yearsboth genders; 3. Expected survival time >= 12 weeks; 4. Patients with histologically confirmed advanced non-small cell lung cancer; 5. Failed in the prior second-line or above standard of care therapies; 6. Archival or biopsy tumor specimens should be provided; 7. Subjects must have measurable lesions according to the response Evaluation Criteria In Solid Tumors (RECIST v1.1); 8. ECOG performance score 0 or 1; 9. AEs related to prior systemic chemotherapy and radical/extensive radiotherapy have recovered to = 50%; 11. Organ functions and coagulation function must meet the basic requirements; 12. Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to any component of the investigational product; 2. Received radiotherapy, chemotherapy, biotherapy, immunotherapy or other anti-tumor drugs within 4 weeks prior to the first dose of study treatment; 3. Presence of central nervous system metastasis; 4. A large amount of pleural and peritoneal effusion or a large amount of pericardial effusion within 4 weeks prior to the first dose of study drug; 5. Any severe or uncontrolled systemic disease judged by the investigator; 6. Patients with poorly controlled heart diseases; 7. Evidence of active infections, including Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) infection; 8. Prior history of other primary malignancies; 9. History of ophthalmic abnormalities; 10. History of severe skin disease requiring interruption of previous EGFR targeted therapy; or chronic skin disease requiring oral or intravenous therapy; 11. History of interstitial lung disease (ILD) or pneumonitis, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.; 12. Peripheral neuropathy of greater than Grade 1; 13. The patients have active autoimmune disease or history of autoimmune disease, are using immunosuppressive agents or systemic hormone therapy; 14. Have undergone allogeneic tissue/solid organ transplant; 15. Women with a positive serum pregnancy, or is breast feeding; subjects who do not agree to use adequate contraception during the treatment and for 6 months after the last dose of study treatment; 16. Active uncontrolled concomitant diseases that might limit subjects compliance with study requirements, or compromise subjects ability to provide written informed consent; 17. Other conditions that in the clinical judgement of the investigator make the patient not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Time to response (TTR);Duration of response (DoR);Disease control rate (DCR);Overall survival (OS);Adverse events (AEs);Serious adverse events (SAEs); | — |
Countries
China
Contacts
Public ContactYuankai Shi
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed