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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

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What is being tested

JMT101 Injection

+ Osimertinib tablet

+ Cisplatin injection

Drug
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

From 18 to 75 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 2024
See protocol details

Summary

Principal SponsorShanghai JMT-Bio Inc.
Study ContactClinical Trials Information Group officer
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 26, 2024

Actual date on which the first participant was enrolled.

This clinical trial is focused on finding an effective treatment for patients with a specific type of advanced lung cancer, known as non-small cell lung cancer, which has a mutation called EGFR Exon 20 insertion. The study compares two treatment combinations: JMT101 with Osimertinib, and Cisplatin with Pemetrexed. This trial is important because patients with this mutation often have limited treatment options, and the study aims to discover if the new combination can provide better outcomes in terms of slowing down the progression of the disease. Participants in this trial will be randomly assigned to receive one of the two treatment combinations. One group will receive JMT101 and Osimertinib, while the other group will receive Cisplatin and Pemetrexed. The trial will measure how long participants live without their cancer getting worse, which is known as progression-free survival, as evaluated by an independent review center. The study will also consider factors like whether participants have brain metastasis and their overall health status to ensure fair comparisons. This study involves around 398 participants and aims to provide insights into which treatment might be more effective and safer for those affected.

Official TitleA 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
NCT06380348
Principal SponsorShanghai JMT-Bio Inc.
Study ContactClinical Trials Information Group officer
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

398 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

6 inclusion criteria required to participate
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

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5 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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