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Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

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

NCT05132777•Shanghai JMT-Bio Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age≥18 years.
•2. 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.
•3. At least 1 measurable lesion according to RECIST 1.1.
•4. ECOG score 0 or 1.
•5. Life expectancy≥3 months.
•6. 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.
•7. 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.
•8. Fully understand and fully informed of this study; must sign and give the written Informed Consent Form (ICF).

Exclusion Criteria

•1. Previously received monoclonal antibody therapy targeting EGFR.
•2. 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..
•3. Treated with other investigational agents within 4 weeks prior to the first dose of the study drug.
•4. Experienced any major surgery (excluding puncture biopsy) or significant trauma within 4 weeks prior to the first dose.
•5. Hypersensitivity or intolerance to our study drug or any excipients of the study drug.
•6. Received strong or moderate inducers of CYP3A4 within 14 days prior to the first dose.
•7. 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).
•8. Had untreated central nervous system metastasis or meningeal metastasis.
•9. History of autoimmune disease, immunodeficiency, including HIV positive, or the presence of other acquired or congenital immunodeficiency, or organ transplantation.
•10. Active hepatitis B, hepatitis C virus or syphilis infection.
+11 more criteria

Key Dates

Start Date

November 20, 2021

Primary Completion Date

September 30, 2023

Completion Date

September 30, 2024

Last Updated

November 24, 2021

Enrollment

155

ESTIMATED participants

Conditions

Locally Advanced or Metastatic Non-Small Cell Lung CancerEGFR Exon20 Insertion Mutations

Interventions

JMT101

DRUG

Osimertinib Mesylate Tablets

DRUG

Contacts

Xiugao Yang

CONTACT

+86-21-60677906 yangxiugao@mail.ecspc.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 24, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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