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Locally Advanced or Metastatic Non-squamous NSCLCPhase 3NCT06735391

A Clinical Study of JMT101 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Sensitive Mutations

A Phase 3 study testing JMT101 and Osimertinib in people with Locally Advanced or Metastatic Non-squamous NSCLC and Harboring EGFR Sensitive Mutations NSCLC, run by Shanghai JMT-Bio Inc. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a Phase 3, randomized, positive-controlled, open-label clinical study. The primary objective is to evaluate the efficacy of JMT101 in combination with osimertinib versus osimertinib alone in patients with newly diagnosed locally advanced or metastatic non-squamous NSCLC harboring EGFR-sensitive mutations. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
JMT101 and Osimertinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
516 participants
Where
1 siteChina
Study dates
23 Oct 2024to 30 May 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be able to understand and voluntarily sign the written informed consent form (ICF);
  • Age ≥ 18 years old, male or female;
  • Participants with histologically or cytologically (pathology report required) confirmed non-squamous NSCLC that is unresectable and locally advanced or metastatic (stage IIIB, IIIC, or IV) according to the International Association for the Study of Lung Cancer (IASLC) 8th edition TNM staging criteria.
  • Participants who have no prior systemic anti-tumor therapy (including anti-EGFR targeted therapy, chemotherapy, biotherapy, immunotherapy, or any investigational drug) for locally advanced or metastatic NSCLC and are not amenable to radical surgery or radiotherapy. For participants with recurrent disease after prior surgical treatment who have undergone prior adjuvant and neoadjuvant therapy, it is necessary to confirm that there is no recurrence or metastasis of tumor within 6 months after surgery, and the randomization is > 6 months from the end of adjuvant/neoadjuvant therapy;
  • Have at least one measurable lesion that meets the RECIST 1.1 criteria at baseline. Target lesions must be either radiation naive or, if previously irradiated, there must be evidence of unequivocal disease progression after radiotherapy. Brain metastases should not be considered as target lesions;
  • ECOG PS score of 0 or 1;
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  • Expected survival ≥ 3 months;
  • Have major organ and bone marrow functions that meet the following criteria within 7 days prior to the first dose in a non-intervention state:
  • 1) Hematology:
  • Absolute neutrophil count (ANC) ≥ 1.5×109/L (prior to the hematology assessment, there is no treatment with cell growth factors within 7 days, and no treatment with long-acting granulocyte colony-stimulating factor (G-CSF) or pegylated recombinant human granulocyte colony-stimulating factor (PEG-CSF) within 14 days);
  • Platelets ≥ 90×109/L (there is no platelet transfusion or recombinant human thrombopoietin therapy within 7 days prior to hematology assessment);
  • Hemoglobin ≥ 90 g/L (there is no red blood cell transfusion/blood transfusion treatment within 14 days prior to hematology assessment); 2) Renal function: Serum creatinine ≤ 1.5×upper limit of normal (ULN), or creatinine clearance (CrCL) ≥ 50 mL/min (using the Cockcroft-Gault formula); 3) Liver function:
  • Total bilirubin ≤ 1.5×ULN (or ≤ 3×ULN for participants with Gilbert syndrome or metastases to liver); b. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN (or AST and ALT ≤ 5×ULN for participants with metastases to liver); 4) Coagulation function:
  • International normalized ratio (INR) ≤ 1.5;
  • Activated partial thromboplastin time (APTT) ≤ 1.5×ULN;

Who cannot join

  • Participants with concomitant mutations such as ALK, ROS1, KRAS, BRAF, RET, MET, NTRK, and HER2, for which targeted drugs are commercially available for clinical treatment, who will not benefit from this clinical study as judged by the investigator; or participants with other mutations who will not benefit from this clinical study as judged by the investigator;
  • Have received Chinese patent medicine preparations for the treatment of lung cancer as an indication within 2 weeks prior to randomization;
  • Have received local radiotherapy within 2 weeks prior to randomization; have received more than 30% of bone marrow irradiation or extensive radiotherapy within 4 weeks prior to randomization;
  • Presence of pericardial effusion (small amount of pericardial effusion stable for ≥ 2 weeks prior to randomization is allowed);
  • Major surgery or severe traumatic injury within 4 weeks prior to the first study treatment, or anticipation of major surgery during the study. Some clinical procedures such as vascular access placement and aspiration biopsy are allowed;
  • Participants with meningeal metastases; spinal cord compression; symptomatic and unstable brain metastases, unless the participants have completed curative treatment, are in stable condition for at least 2 weeks prior to randomization and do not require steroid therapy. Participants with asymptomatic brain metastases may be enrolled if the investigator assesses that there is no indication for immediate curative treatment;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

China1 site, 1 recruiting

  • Sun Yat sen University Cancer Prevention and Treatment Center

    Guangzhou

    Li Zhang

    Recruiting

Other trials in China

About this study

Official title: A Phase 3 Clinical Study of JMT101 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Sensitive Mutations

This is a Phase 3, randomized, positive-controlled, open-label clinical study. The primary objective is to evaluate the efficacy of JMT101 in combination with osimertinib versus osimertinib alone in patients with newly diagnosed locally advanced or metastatic non-squamous NSCLC harboring EGFR-sensitive mutations.

Being tested
JMT101, Osimertinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JMT101Drug

    Also called Recombinant Humanized Anti-Epidermal Growth Factor Receptor Monoclonal Antibody Injection

    JMT101 is a recombinant humanized anti-EGFR monoclonal antibody.

  • OsimertinibDrug

    EGFR TKI

Study groups in NCT06735391
Study groupRoleWhat they receive
JMT101ExperimentalJMT101 6mg/kg,intravenous drip,once every two weeks (Q2W), and osimertinib 80mg,orally,once daily(QD),with every 4weeks as a treatment cycle
Receives: Drug: JMT101
OsimertinibExperimentalOsimertinib 80 mg, orally, QD, with every 4 weeks as a treatment cycle.
Receives: Drug: Osimertinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS assessed by the independent review committee (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Measured: Up to approximately 44 months after the first participant is enrolled

Secondary outcomes (11)

  1. Overall survival (OS)

    Measured: Up to approximately 44 months after the first participant is enrolled

  2. Objective response rate (ORR) assessed by IRC based on RECIST 1.1

    Measured: Up to approximately 44 months after the first participant is enrolled

  3. duration of response (DOR) assessed by IRC based on RECIST 1.1

    Measured: Up to approximately 44 months after the first participant is enrolled

  4. disease control rate (DCR) assessed by IRC based on RECIST 1.1

    Measured: Up to approximately 44 months after the first participant is enrolled

  5. DOR assessed by the investigator based on RECIST 1.1

    Measured: Up to approximately 44 months after the first participant is enrolled

  6. ORR assessed by the investigator based on RECIST 1.1

    Measured: Up to approximately 44 months after the first participant is enrolled

  7. DCR assessed by the investigator based on RECIST 1.1

    Measured: Up to approximately 44 months after the first participant is enrolled

  8. Adverse events incidence and severity

    Measured: Up to approximately 44 months after the first participant is enrolled

  9. Serum concentration of JMT101

    Measured: Up to approximately 44 months after the first participant is enrolled

  10. Incidence and titer of anti-drug antibodies (ADAs)

    Measured: Up to approximately 44 months after the first participant is enrolled

  11. The incidence of neutralising antibodies (NAbs)

    Measured: Up to approximately 44 months after the first participant is enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2024
  2. Study start23 Oct 2024
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase 3, randomized, positive-controlled. To evaluate the efficacy of JMT101 in combination with osimertinib versus osimertinib alone in patients with previously untreated, locally advanced, or metastatic non-squamous NSCLC harboring EGFR-sensitive mutations.
Masking
Single blind
Who is masked
Participant
Enrolment
516 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06735391
Sponsor's protocol ID
JMT101-018
Status last verified
Dec 2024
First submitted
7 Dec 2024
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JMT101 and Osimertinib in people with Locally Advanced or Metastatic Non-squamous NSCLC and Harboring EGFR Sensitive Mutations NSCLC, run by Shanghai JMT-Bio Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS assessed by the independent review committee (IRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (time frame: Up to approximately 44 months after the first participant is enrolled). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06735391.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.

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