Overview
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.
Description
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.
Eligibility
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.