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

Sponsor
Shanghai JMT-Bio Inc.
Study ID
NCT06380348
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Local Advanced or Metastatic NSCLC

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • JMT101 Injection — DRUG
    JMT101 Injection, 6 mg/kg intravenously, over 90 mins every 14 days
  • Osimertinib tablet — DRUG
    Osimertinib 160mg once po everyday
  • Cisplatin injection — DRUG
    Cisplatin 75mg/m\^2, IV infusion, on day-1 at every cycle of 21days, 4 cycles at most.
  • Pemetrexed injection — DRUG
    Pemetrexed 500mg/m\^2, IV infusion, on day-1 at every cycle of 21 days.

Study Details

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).

Key Dates

Start date
Apr 26, 2024
Status verified
Apr 2024
Primary completion
Mar 26, 2027
Completion
Mar 26, 2028

Study Design

Enrollment
398 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: JMT101 combined with Osimertinib
  • Active Comparator: Cisplatin combined with pemetrexed
    Participants randomized into chemotherapy arm can receive up to 4 cycles of pemetrexed + cisplatin (pemetrexed 500 mg/m\^2 + cisplatin 75mg/m\^2, IV infusion, every 3 weeks) as the initial treatment. Participants whose disease has not progressed after 4 cycles of first-line platinum-based doublet chemotherapy may receive pemetrexed maintenance monotherapy until a treatment discontinuation criterion is met.

Primary Outcome Measure

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 ]

Central Contacts