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

NCT05132777 | Unknown Phase 2

• 1 other identifier: JMT101-CSP-003
• Study Type: interventional
• Target: 155
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Locally Advanced or Metastatic Non-Small Cell Lung Cancer; EGFR Exon20 Insertion Mutations

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (13)

• Confirmed ORR Assessed by the Investigator per RECIST Version 1.1

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

• Duration of Response (DoR)

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

• Disease control rate (DCR)

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

• Progression free survival (PFS)

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

• Overall survival (OS)

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

Study Arms (1)

JMT101 in combination with Osimertinib

EXPERIMENTAL

Drug: JMT101; Drug: Osimertinib Mesylate Tablets

Interventions

JMT101 DRUG

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

JMT101 in combination with Osimertinib

Osimertinib Mesylate Tablets DRUG

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

JMT101 in combination with Osimertinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead
• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Li Zhang

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiugao Yang

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 24, 2021
• Study Start: November 20, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2024
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share