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Trial Title:
JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations
NCT ID:
NCT06380348
Condition:
Local Advanced or Metastatic NSCLC
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Pemetrexed
Osimertinib
Conditions: Keywords:
Harboring EGFR 20ins mutation
Without prior systemic therapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JMT101 Injection
Description:
JMT101 Injection, 6 mg/kg intravenously, over 90 mins every 14 days
Arm group label:
JMT101 combined with Osimertinib
Intervention type:
Drug
Intervention name:
Osimertinib tablet
Description:
Osimertinib 160mg once po everyday
Arm group label:
JMT101 combined with Osimertinib
Intervention type:
Drug
Intervention name:
Cisplatin injection
Description:
Cisplatin 75mg/m^2, IV infusion, on day-1 at every cycle of 21days, 4 cycles at most.
Arm group label:
Cisplatin combined with pemetrexed
Intervention type:
Drug
Intervention name:
Pemetrexed injection
Description:
Pemetrexed 500mg/m^2, IV infusion, on day-1 at every cycle of 21 days.
Arm group label:
Cisplatin combined with pemetrexed
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).
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 26, 2024
Completion date:
March 26, 2028
Lead sponsor:
Agency:
Shanghai JMT-Bio Inc.
Agency class:
Industry
Source:
Shanghai JMT-Bio Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06380348
