Local Advanced or Metastatic NSCLC
Conditions
Keywords
Harboring EGFR 20ins mutation, Without prior systemic therapy
Brief summary
This is a multicenter, randomized, open-label, parallel-controlled phase 3 study. This study aims to evaluate the efficacy and safety of JMT101 combined with Osimertinib compared with Cisplatin combined with pemetrexed in participants with local advanced or metastatic non-small-cell lung cancer harboured EGFR 20ins mutation without prior systemic therapy. Primary objective of this study is to assess the efficacy of JMT101 combined with Osimertinib versus Cisplatin combined with pemetrexed using by （Independent Review Center）IRC-assessed Progression Free Survival (PFS) per RECIST 1.1 as primary endpoint. Approximately 398 participants are estimated to be randomized into the study. Participants enrolled will be randomized to JMT101 or Cisplatin chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without) and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 versus 1).
Interventions
DRUGJMT101 Injection
JMT101 Injection, 6 mg/kg intravenously, over 90 mins every 14 days
Osimertinib 160mg once po everyday
DRUGCisplatin injection
Cisplatin 75mg/m\^2, IV infusion, on day-1 at every cycle of 21days, 4 cycles at most.
Pemetrexed 500mg/m\^2, IV infusion, on day-1 at every cycle of 21 days.
Sponsors
Shanghai JMT-Bio Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18-75 years old. 2. Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the IASLC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy. For central laboratory confirmation of EGFR exon 20 insertion mutation with tumour tissue/blood sample. 3. At least 1 measurable lesion per RECIST Version 1.1 4. Life expectancy ≥ 12 weeks 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 6. Adequate organ and hematologic function
Exclusion criteria
1. Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC. 2. Central nervous system metastasis with associated symptom and signs. 3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q. 4. History of interstitial lung disease, or infectious pneumonitis need heavy antibiotics therapy 5. As judged by the investigator, unsuitable for attending the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) as assessed by Independent Review Center (IRC) per RECIST 1.1 | Up to approximately 35 months after the first participant is randomized |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR) by IRC per RECIST 1.1 | Up to approximately 35 months after the first participant is randomized |
| Duration of Response (DoR) by IRC per RECIST 1.1 | Up to approximately 35 months after the first participant is randomized |
| Overall Survival (OS) | Up to approximately 35 months after the first participant is randomized |
| ORR by investigator per RECIST 1.1 | Up to approximately 35 months after the first participant is randomized |
| DoR by investigator per RECIST 1.1 | Up to approximately 35 months after the first participant is randomized |
| PFS by investigator per RECIST 1.1 | Up to approximately 35 months after the first participant is randomized |
Contacts
Primary ContactClinical Trials Information Group officer
Outcome results
None listed