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Locally Advanced or Metastatic Non-Small Cell Lung CancerPhase 2NCT05132777

Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Non-Small Cell Lung Cancer

A Phase 2 study testing JMT101 and Osimertinib Mesylate Tablets in people with Locally Advanced or Metastatic Non-Small Cell Lung Cancer and EGFR Exon20 Insertion Mutations, run by Shanghai JMT-Bio Inc..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a phase II, open label, multi-center study to evaluate the efficacy and safety of JMT101 combined with Osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
JMT101 and Osimertinib Mesylate Tablets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
No sites listed yet
Study dates
20 Nov 2021to 30 Sep 2024
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Age≥18 years.
  • Patients with non-irradiable, non-operable, histologically or cytologically confirmed Stage IIIB~IV NSCLC, harboring an EGFR exon 20 insertion mutation (including duplication mutations), who have progressed on or intolerable to prior platinum-based chemotherapy.
  • At least 1 measurable lesion according to RECIST 1.1.
  • ECOG score 0 or 1.
  • Life expectancy≥3 months.
  • Adequate organ function(tested within 7 days prior to the first dose): Absolute neutrophil count (ANC)≥1.5×10^9 /L, Platelets≥90×10^9/L, Hemoglobin≥9 g/dL or ≥5.6 mmol/L; Serum creatinine <1.5 × ULN; Total bilirubin ≤1.5×ULN (if liver metastases are present,≤3×ULN), AST and ALT≤3×ULN (if liver metastases are present,≤5×ULN)；INR or PT≤1.5×ULN, APTT≤1.5×ULN.
  • A female of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose. Any male and female patient of childbearing potential must agree to use effective contraception method throughout the trial period and for another half year after the end of the trial.
  • Fully understand and fully informed of this study; must sign and give the written Informed Consent Form (ICF).

Who cannot join

  • Previously received monoclonal antibody therapy targeting EGFR.
  • Previous chemotherapy, biotherapy, targeted therapy, immunotherapy or other anti-tumor treatment within 4 weeks prior to the first dose of the study drug, 2 weeks (or 5 half-lives whichever is longer) for using small molecule targeted drugs, 2 weeks for using radiotherapy..
  • Treated with other investigational agents within 4 weeks prior to the first dose of the study drug.
  • Experienced any major surgery (excluding puncture biopsy) or significant trauma within 4 weeks prior to the first dose.
  • Hypersensitivity or intolerance to our study drug or any excipients of the study drug.
  • Received strong or moderate inducers of CYP3A4 within 14 days prior to the first dose.
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  • The adverse reactions of previous antitumor treatment have not yet recovered to Grade≤ 1 based on CTCAE 5.0 or baseline (except for the toxicity without safety risk judged by the investigator, such as alopecia).
  • Had untreated central nervous system metastasis or meningeal metastasis.
  • History of autoimmune disease, immunodeficiency, including HIV positive, or the presence of other acquired or congenital immunodeficiency, or organ transplantation.
  • Active hepatitis B, hepatitis C virus or syphilis infection.
  • History of severe cardiovascular disease.
  • Have difficulty with swallowing medications, or there is a condition seriously affecting the gastrointestinal absorption as judged by investigators.
  • Other malignant tumors diagnosed within 5 years prior to the first dose, with the exception of adequately treated skin basal cell carcinoma, skin squamous cell carcinoma, preinvasive cervical carcinoma or breast cancer that was effectively removed and not requiring or not expected to require other treatment during the study period.
  • History of interstitial lung disease, drug-induced interstitial lung disease, radioactive pneumonia requiring steroid treatment, or any evidence of clinical active interstitial lung disease.
  • History of other serious systemic diseases, in the judgment of the investigator, that make the subject unfit for the study.
  • Alcohol or drug dependence.
  • Had an unequivocal history of neurological or psychiatric disorders, including epilepsy or dementia.
  • Pregnant or lactating woman.
  • Not suitable for this study as determined by the investigator due to other reasons.
  • Patients harboring EGFR exon20 insertion mutation and also have other EGFR TKI-sensitizing EGFR mutations, such as G719X mutation in exon 18, exon 19 deletion mutation (19 del), exon 20 T790M or S768I mutation, exon 21 L858R mutation, or L861Q mutation.
  • Previously received drugs that developed for EGFR exon20 insertion mutated NSCLC ( such as TAK-788, Poziotinib, DZD9008 or JNJ-61186372); the short-term use is allowed, such as≤2 weeks. Responsive to previous EGFR-TKI treatment (including the best overall response of complete response, partial response, or stable disease last more than 6 months). Previously received PD-1 or PD-L1 monoclonal antibody therapy within 3 months prior to the first dose.

Trial locations and contacts

No sites are listed yet.

Xiugao Yang contact

+86-21-60677906

yangxiugao@mail.ecspc.com

About this study

Official title: A Phase II, Open Label, Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

This study is a phase II, open label, multi-center study to evaluate the efficacy and safety of JMT101 combined with Osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.

Being tested
JMT101, Osimertinib Mesylate Tablets
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.

  • JMT101Drug

    JMT101, 6 mg/kg, IV infusion once every two weeks (one treatment cycle is 4 weeks).

  • Osimertinib Mesylate TabletsDrug

    Osimertinib, 160 mg, Oral administration once daily (one treatment cycle is 4 weeks).

Study groups in NCT05132777
Study groupRoleWhat they receive
JMT101 in combination with OsimertinibExperimentalNot described
Receives: Drug: JMT101; Drug: Osimertinib Mesylate Tablets

What is being measured

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

  1. Confirmed Objective Response Rate (ORR) Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1

    Measured: From the first dose to disease progression or end of study, an average of 1 year

Secondary outcomes (13)

  1. Confirmed ORR Assessed by the Investigator per RECIST Version 1.1

    Measured: From the first dose to disease progression or end of study, an average of 1 year

  2. Duration of Response (DoR)

    Measured: From the first dose to disease progression or end of study, an average of 1 year

  3. Disease control rate (DCR)

    Measured: From the first dose to disease progression or end of study, an average of 1 year

  4. Progression free survival (PFS)

    Measured: From the first dose to disease progression or end of study, an average of 1 year

  5. Overall survival (OS)

    Measured: From the first dose to death or end of study, an average of 1.5 years

  6. Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAEV5.0))

    Measured: From the enrollment until 30 days after the last dose

  7. Immunogenicity profile of JMT101

    Blood samples will be collected at specified timepoints to detect the presence of anti-drug antibodies and neutralizing antibodies against JMT101

    Measured: From the enrollment until 30 days after the last dose

  8. Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.

    Measured: From the first dose to cycle 3 day 1 (each cycle is 28 days)

  9. Maximum measured plasma concentration (Cmax) of JMT101.

    Measured: From the first dose to cycle 3 day 1 (each cycle is 28 days)

  10. Time to maximum plasma concentration (Tmax) of JMT101.

    Measured: From the first dose to cycle 3 day 1 (each cycle is 28 days)

  11. Half-life (T1/2) of JMT101.

    Measured: From the first dose to cycle 3 day 1 (each cycle is 28 days)

  12. Cl/F of JMT101.

    Measured: From the first dose to cycle 3 day 1 (each cycle is 28 days)

  13. Detection of cancer-related biomarkers in circulating tumor DNA from plasma to analyse the corcorrelation with clinical efficacy and drug resistance.

    Measured: From the enrollment to disease progression, an average of 1 year

Timeline

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

  1. First posted24 Nov 2021
  2. Study start20 Nov 2021 (estimated)
  3. Primary completion30 Sep 2023 (estimated)
  4. Study completion30 Sep 2024 (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
Masking
None (open label)
Enrolment
155 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05132777
Sponsor's protocol ID
JMT101-CSP-003
Status last verified
Nov 2021
First submitted
1 Nov 2021
Last updated
24 Nov 2021
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 and Osimertinib Mesylate Tablets in people with Locally Advanced or Metastatic Non-Small Cell Lung Cancer and EGFR Exon20 Insertion Mutations, run by Shanghai JMT-Bio Inc..

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 21 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: status not confirmed, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact Xiugao Yang (+86-21-60677906, yangxiugao@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed Objective Response Rate (ORR) Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1 (time frame: From the first dose to disease progression or end of study, an average of 1 year). 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 NCT05132777.

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 24 Nov 2021.

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