Inetetamab in Combination With Pyrotinib in HER2 Mutant or Amplified Advanced Non-small Cell Lung… (NCT05016544) | Clinical Trial Compass
UnknownPhase 1/2
Inetetamab in Combination With Pyrotinib in HER2 Mutant or Amplified Advanced Non-small Cell Lung Cancer
China48 participantsStarted 2021-07-28
Plain-language summary
This is a Phase 1, open-label study to evaluate the safety and the efficacy of inetetamab in combination with pyrotinib in patients in HER2 mutant or amplified patients with advanced non-small cell lung cancer
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age over 18;
✓. Histologically or cytologically documented metastatic NSCLC, HER2 activation amplification or mutation stage IIIB-IV NSCLC patient;
✓. At least 1 measurable lesion according to RECIST 1.1;
✓. ECOG score 0 or 1;
✓. Life expectancy of at least 3 months;
✓. Within one week before admission, blood routine examination was basically normal:
✕. Patients who have received anti-HER2 monoclonal antibody therapy;
✕. Have received chemotherapy, biotherapy, targeted therapy, immunotherapy and other anti-tumor therapies within 4 weeks prior to the first use of the study drug including: oral small molecule targeted drugs within 2 weeks prior to the first use of the study drug or within 5 half-lives of known drugs (depending on the time);Radiotherapy was performed within 2 weeks prior to the first administration of the study drug;
✕. Have received other clinical study drugs within 4 weeks prior to the first study drug administration;
✕. Patients who underwent major surgery within 4 weeks prior to the first dosing of the study drug(except needle biopsy or significant trauma);
What they're measuring
1
Dose escalation
Timeframe: Up to 21 days after the first dose
2
Incidence of adverse events
Timeframe: Up to 30 days after the last dose of inetetamab or pyrotinib
✕. Those who have been known to have allergic history to the drug components of this regimen;
✕. Study drugs that had used a CYP3A4 inhibitor, inducer, or a narrow therapeutic window with a CYP3A4-sensitive substrate ,P-ep strong inducer and inhibitor within 14 days before first administration;
✕. The adverse reactions of previous antitumor therapy have not recovered to CTCAE 5.0 grade 1(Hair loss and other toxicities were excluded for which the researchers judged no safety risk);
✕. Patients with central nervous system metastasis and clinical symptoms;