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

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is a Phase Ib, open label, multi-center study of to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (Afatinib or Osimertinib) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai JMT-Bio Inc.
• Collaborator: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Treatments: Afatinib; Osimertinib

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.