Lung cancer
Conditions
Interventions
Cohort 1 - Dose Level 1:Intrapleural perfusion of Amivantamab 87.5mg, single dose
Cohort 1 - Dose Level 2:Intrapleural perfusion of Amivantamab 175mg, single dose
Cohort 1 - Dose Level 3:Intrapleural perfusion of Amivantamab 350mg, single dose
Cohort 1 - Dose Level 4:Intrapleural perfusion of Amivantamab 700mg, single dose
Expansion Cohort - Repeated Administration:Intrapleural perfusion of Amivantamab [MTD dose], once per week, 2 weeks per cycle
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily agrees to participate in this study, provides signed informed consent, and demonstrates good compliance. 2. Age >= 18 years and = 3 months.
Exclusion criteria
Exclusion criteria: 1. Presence of other active malignant tumors. 2. Severe localized pleural effusion that is unlikely to benefit from intrapleural therapy. 3. Any clinical condition that precludes intrapleural perfusion therapy, such as severe coagulation dysfunction (platelet count 1.5, etc.), or inability to cooperate with thoracentesis. 4. Planned or current participation in another clinical trial involving investigational drugs or devices that may interfere with the assessment of endpoints in this study. 5. Known allergy to recombinant proteins or any excipients contained in the Amivantamab formulation. 6. Any other condition that, in the judgment of the investigator, makes the patient unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-Limiting Toxicity;Maximum Tolerated Dose;Incidence of grade >= 3 adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| MPE response rate;Puncture-Free Survival;Quality of life;Pharmacokinetic Parameters; | — |
Countries
China
Contacts
Public ContactWang Ye
West China Hospital, Sichuan University
Outcome results
None listed