This was a multicenter, open-label phase 2 study. This study aimed to evaluate the efficacy and safety of JMT101 combined with Osimertinib in participants with local advanced or metastatic non-small-cell lung cancer harbouring EGFR common mutation with or without prior systemic therapy. Efficacy indexes included investigator-assessed Overall Response Rate(ORR), Disease Control Rate(DCR), Duration of Response( DoR), Progression Free Survival (PFS) per RECIST 1.1 and Overall Survival (OS). Safety indexes included Adverse Events incidence and severity. This study included 4 cohorts, cohort 1 included EGFR-mutated advanced NSCLC patients without prior systemic therapy and accepted JMT101 6mg/Kg Q3W and Osimertinib 80mg QD therapy. Cohort 2 included EGFR-mutated advanced NSCLC patients who failed with prior generation 1 or 2 EGFR-TKIs therapy and accepted JMT101 6mg/Kg Q2W and Osimertinib 80mg QD therapy. Cohort 3 included advanced EGFR common mutation NSCLC patients who failed with prior generation 3 EGFR-TKIs but did not accept chemotherapy and accepted JMT101 6mg/Kg Q2W and Osimertinib 80mg or 160mg QD therapy. Cohort 4 included EGFR-mutated advanced EGFR NSCLC patients who failed with prior generation 3 EGFR-TKIs and platinum-based chemotherapy and accepted JMT101 6mg/Kg Q2W and Osimertinib 80mg or 160mg QD therapy.
Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
161
JMT101 Injection, 6 mg/kg intravenously, over 90 mins every 14 or 21 days
Osimertinib 80 or 160mg po everyday
Li Zhang
Beijing, Beijing Municipality, China
Adverse events incidence and severity
Time frame: Up to approximately 60 months after the first participant was enrollment
Overall Response Rate(ORR)per RECST 1.1
Time frame: Up to approximately 60 months after the first participant was enrollment
Overall Survival (OS)
Time frame: Up to approximately 60 months after the first participant was enrollment
Progression Free Survival (PFS) per RECIST 1.1
Time frame: Up to approximately 60 months after the first participant was enrollment
Duration of Response (DoR) per RECST 1.1
Time frame: Up to approximately 60 months after the first participant was enrollment
Disease Control Rate (DCR) per RECST 1.1
Time frame: Up to approximately 60 months after the first participant was enrollment
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