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Local Advanced or Metastatic NSCLCPhase 2NCT06391944

JMT101 Combined With Osimertinib in Patients With Stage Ⅲb-Ⅳ Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Common Mutations

A Phase 2 study testing JMT101 Injection and Osimertinib tablet in people with Local Advanced or Metastatic NSCLC and Harboring EGFR Common Mutation, run by Shanghai JMT-Bio Inc. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This was a multicenter, open-label phase 2 study. This study aimed to evaluate the efficacy and safety of JMT101 combined with Osimertinib in participants with local advanced or metastatic non-small-cell lung cancer harbouring EGFR common mutation with or without prior systemic therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
JMT101 Injection and Osimertinib tablet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
1 siteChina
Study dates
21 Nov 2021to 21 Nov 2026
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 AJCC TNM staging criteria) or metastatic (Stage IV) harbouring EGFR common mutation with tumour tissue/blood sample. For cohort 1, should not receive prior systemic therapy, for cohort 2, should fail with generation 1 or 2 EGFR-TKIs therapy, for cohort 3, should fail with generation 3 EGFR-TKIs therapy but did not accept chemotherapy, for cohort 4, patients should fail with generation 3 and platinum-based chemotherapy.
  • 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
  • Women with fertility tested negative for blood pregnancy within 7 days prior to trial screening; Any male or female patients with fertility must agree to use effective contraceptive methods throughout the entire trial period and within six months after the end of the trial.
  • Patients must give informed consent to this study before the trial and voluntarily sign a written informed consent form.

Who cannot join

  • Previously received EGFR monoclonal antibody therapy.
  • Have received anti-tumor treatments such as chemotherapy, biological therapy, targeted therapy, immunotherapy, etc. within 4 weeks prior to the first use of the study drug.
  • Have undergone major organ surgery (excluding biopsy) or experienced significant trauma within 4 weeks prior to the first use of the study drug.
  • Have received other clinical study drugs within 4 weeks prior to the first use of the study drug.
  • Known hypersensitivity or intolerance to any component of the study drug or its excipients.
  • Those who use strong or moderate CYP3A4 inducers within 14 days before the first administration of the study drug.
Show all 19Show fewer
  • The adverse reactions of previous anti-tumor treatments have not yet recovered to CTCAE 5.0 evaluation ≤ level 1 except for toxicity such as alocepia, which is judged to be of no safety risk by researchers;
  • Central nervous system metastasis or meningeal metastasis with clinical symptoms.
  • Having a history of autoimmune diseases, immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.
  • Active hepatitis B (hepatitis B virus titer>1000 copies/mL or 200 IU/mL); Hepatitis C virus and syphilis infections.
  • Have a history of serious cardiovascular disease.
  • Unable to swallow medication orally, or has a condition that has been determined by researchers to seriously affect gastrointestinal absorption.
  • Within 5 years prior to the first use of the study drug, there were other malignant tumors, except for localized tumors such as cervical carcinoma in situ, basal cell carcinoma of the skin, and prostate carcinoma in situ that have been confirmed to be cured.
  • Any evidence of a history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid treatment, or clinically active interstitial lung disease.
  • Patients with a history of other serious systemic diseases who have been determined by the researchers to be unsuitable for clinical trials.
  • Known to have alcohol or drug dependence.
  • Has a clear history of neurological or psychiatric disorders, including epilepsy or dementia.
  • Pregnant or lactating women.
  • The researchers believe that the subjects are not suitable to participate in this clinical study due to other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Li Zhang

    Beijing, Beijing Municipality, 100036

Other trials in China

About this study

Official title: A Phase 2, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Stage Ⅲb-Ⅳ Non-Small Cell Lung Cancer With EGFR Common Mutations

This was a multicenter, open-label phase 2 study. This study aimed to evaluate the efficacy and safety of JMT101 combined with Osimertinib in participants with local advanced or metastatic non-small-cell lung cancer harbouring EGFR common mutation with or without prior systemic therapy.

Efficacy indexes included investigator-assessed Overall Response Rate(ORR), Disease Control Rate(DCR), Duration of Response( DoR), Progression Free Survival (PFS) per RECIST 1.1 and Overall Survival (OS). Safety indexes included Adverse Events incidence and severity. This study included 4 cohorts, cohort 1 included EGFR-mutated advanced NSCLC patients without prior systemic therapy and accepted JMT101 6mg/Kg Q3W and Osimertinib 80mg QD therapy. Cohort 2 included EGFR-mutated advanced NSCLC patients who failed with prior generation 1 or 2 EGFR-TKIs therapy and accepted JMT101 6mg/Kg Q2W and Osimertinib 80mg QD therapy. Cohort 3 included advanced EGFR common mutation NSCLC patients who failed with prior generation 3 EGFR-TKIs but did not accept chemotherapy and accepted JMT101 6mg/Kg Q2W and Osimertinib 80mg or 160mg QD therapy. Cohort 4 included EGFR-mutated advanced EGFR NSCLC patients who failed with prior generation 3 EGFR-TKIs and platinum-based chemotherapy and accepted JMT101 6mg/Kg Q2W and Osimertinib 80mg or 160mg QD therapy.

Read the detailed description

Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.

Being tested
JMT101 Injection, Osimertinib tablet
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • JMT101 InjectionDrug

    JMT101 Injection, 6 mg/kg intravenously, over 90 mins every 14 or 21 days

  • Osimertinib tabletDrug

    Osimertinib 80 or 160mg po everyday

Study groups in NCT06391944
Study groupRoleWhat they receive
JMT101 combined with OsimertinibExperimentalJMT101 6mg/kg iv Q2W or Q3W, osimertinib 80mg or 160mg po QD until a treatment discontinuation criterion is met.
Receives: Drug: JMT101 Injection; Drug: Osimertinib tablet

What is being measured

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

  1. Adverse events incidence and severity

    Measured: Up to approximately 60 months after the first participant was enrollment

  2. Overall Response Rate（ORR）per RECST 1.1

    Measured: Up to approximately 60 months after the first participant was enrollment

Secondary outcomes (4)

  1. Overall Survival (OS)

    Measured: Up to approximately 60 months after the first participant was enrollment

  2. Progression Free Survival (PFS) per RECIST 1.1

    Measured: Up to approximately 60 months after the first participant was enrollment

  3. Duration of Response (DoR) per RECST 1.1

    Measured: Up to approximately 60 months after the first participant was enrollment

  4. Disease Control Rate (DCR) per RECST 1.1

    Measured: Up to approximately 60 months after the first participant was enrollment

Timeline

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

  1. First posted30 Apr 2024
  2. Study start21 Nov 2021
  3. Primary completion17 May 2023
  4. Study completion21 Nov 2026 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
For cohort 1, patients received JMT101 6mg/Kg Q3W and Osimertinib 80mg QD. For cohord 2, patients received JMT101 6mg/Kg Q2W and Osimertinib 80mg QD.For cohort 3 and cohort 4, patients were randomized 1:1 to JMT101 6mg/Kg and Osimertinib 80mg or JMT101 6mg/Kg and Osimertinib 160mg.
Masking
None (open label)
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06391944
Sponsor's protocol ID
JMT101-CSP-005
Status last verified
Apr 2024
First submitted
26 Apr 2024
Last updated
30 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JMT101 Injection and Osimertinib tablet in people with Local Advanced or Metastatic NSCLC and Harboring EGFR Common Mutation, 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 8 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events incidence and severity (time frame: Up to approximately 60 months after the first participant was enrollment). The study lists 2 primary outcomes in all. 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 NCT06391944.

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 30 Apr 2024.

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