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NCT Number: 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

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).

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Key information

Conditions

Local Advanced or Metastatic NSCLC Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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 outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 35 months after the first participant is randomized

  2. Overall Response Rate (ORR) by IRC per RECIST 1.1

    Time frame: Up to approximately 35 months after the first participant is randomized

  3. Duration of Response (DoR) by IRC per RECIST 1.1

    Time frame: Up to approximately 35 months after the first participant is randomized

  4. PFS by investigator per RECIST 1.1

    Time frame: Up to approximately 35 months after the first participant is randomized

  5. ORR by investigator per RECIST 1.1

    Time frame: Up to approximately 35 months after the first participant is randomized

  6. DoR by investigator per RECIST 1.1

    Time frame: Up to approximately 35 months after the first participant is randomized

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Information Group officer

CONTACT

[email protected]

86-0311-69085587

Sponsors and collaborators

Lead sponsor

Shanghai JMT-Bio Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 23, 2024
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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