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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

NCT06380348 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 398

Last updated 2024-04-23

No results posted yet for this study

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).

Conditions

  • Local Advanced or Metastatic NSCLC

Interventions

DRUG

JMT101 Injection

JMT101 Injection, 6 mg/kg intravenously, over 90 mins every 14 days

DRUG

Osimertinib tablet

Osimertinib 160mg once po everyday

DRUG

Cisplatin injection

Cisplatin 75mg/m\^2, IV infusion, on day-1 at every cycle of 21days, 4 cycles at most.

DRUG

Pemetrexed injection

Pemetrexed 500mg/m\^2, IV infusion, on day-1 at every cycle of 21 days.

Sponsors & Collaborators

  • Shanghai JMT-Bio Inc.

    lead INDUSTRY

Principal Investigators

  • Li Zhang, M.D. · Cancer Prevention and Treatment Center of Sun Yat sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-26
Primary Completion
2027-03-26
Completion
2028-03-26

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06380348 on ClinicalTrials.gov