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.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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;
You may not be if
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;
