Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer

Launched by SHANGHAI JMT-BIO INC. · Jun 24, 2020

Keywords

ClinConnect Summary

The objective of the trial is to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (afatinib or osimertinib) in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.

This study consists of two parts (Stage I and Stage II). Stage I was a dose escalation study, and Stage II was a dose expansion study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Pathologically or cytologically confirmed, locally advanced or metastatic NSCLC, harboring an EGFR exon 20 insertion mutation. ( non-irradiable, non-operable);
• • No previous treatment or first-line treatment failed NSCLC;
• • At least 1 measurable lesion according to RECIST 1.1;
• • ECOG score 0 or 1;
• Exclusion Criteria:
• • Previously treated with EGFR antibody;
• • Symptomatic brain metastasis;
• • Interstitial pneumopathy;
• • Known hypersensitivity to any ingredient of JMT101, afatinib, osimertinib or their excipients;
• • Receiving an investigational product in another clinical study within 4 weeks;
• • History of serious systemic diseases;
• • History of serious autoimmune diseases;
• • Pregnancy or lactating women.