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Not yet recruiting NCT06380348

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

Phase III Interventional Local Advanced or Metastatic NSCLC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JMT101 Injection, Osimertinib tablet, Cisplatin injection, Pemetrexed injection.
Who it may be relevant to
Registry conditions: Local Advanced or Metastatic NSCLC. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Open-label, Parallel-controlled Phase 3 Study of Combination JMT101 and Osimertinib Compared With Cisplatin -Pemetrexed in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Overview

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

  • 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.

Primary outcome measures

  • Progression Free Survival (PFS) as assessed by Independent Review Center (IRC) per RECIST 1.1 [Time frame: Up to approximately 35 months after the first participant is randomized]
Secondary outcome measures (6)
  • Overall Survival (OS) [Time frame: Up to approximately 35 months after the first participant is randomized]
  • Overall Response Rate (ORR) by IRC per RECIST 1.1 [Time frame: Up to approximately 35 months after the first participant is randomized]
  • Duration of Response (DoR) by IRC per RECIST 1.1 [Time frame: Up to approximately 35 months after the first participant is randomized]
  • PFS by investigator per RECIST 1.1 [Time frame: Up to approximately 35 months after the first participant is randomized]
  • ORR by investigator per RECIST 1.1 [Time frame: Up to approximately 35 months after the first participant is randomized]
  • DoR by investigator per RECIST 1.1 [Time frame: Up to approximately 35 months after the first participant is randomized]

Eligibility criteria

Inclusion criteria

  • Age between 18-75 years old.
  • 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.
  • At least 1 measurable lesion per RECIST Version 1.1
  • Life expectancy ≥ 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Adequate organ and hematologic function

Exclusion criteria

  • Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
  • Central nervous system metastasis with associated symptom and signs.
  • Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
  • History of interstitial lung disease, or infectious pneumonitis need heavy antibiotics therapy
  • As judged by the investigator, unsuitable for attending the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06380348 · JMT101-012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗