Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification

  • STATUS
    Recruiting
  • End date
    Nov 30, 2024
  • participants needed
    250
  • sponsor
    Hutchison Medipharma Limited
Updated on 8 December 2021
chemoradiotherapy
pemetrexed
carboplatin
EGFR
osimertinib
lung carcinoma

Summary

This study will look at how effective the study drug(Savolitinib combined with Osimertinib) versus Pemetrexed combined with platinum in treatment of patients with locally advanced or metastatic NSCLC with MET amplification after failure of the first-line EGFR inhibitor therapy.

Description

This is a multicenter, randomized, controlled, open, phase III clinical study to evaluate the clinical efficacy and safety of Savolitinib combined with Osimertinib in treatment of patients with locally advanced or metastatic NSCLC with MET amplification after failure of EGFR inhibitor therapy.

Details
Condition nsclc, Non-Small Cell Lung Cancer
Treatment Savolitinib + Osimertinib, Pemetrexed + Cisplatin /Carboplatin
Clinical Study IdentifierNCT05015608
SponsorHutchison Medipharma Limited
Last Modified on8 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Fully aware this study and voluntary to sign the informed consent form, and willing and able to comply with the study procedure
Age 18 and 75 years
In accordance with the 8th Edition of TNM staging for lung cancers by International Association for the Study of Lung Cancer and American Joint Committee on Cancer, patients with histologically or cytologically confirmed unresectable and non-suitable for radical concurrent chemoradiotherapy, locally advanced or metastatic (stage IIIB, IIIC or IV) NSCLC
EGFR sensitive mutations prior to the first-line EGFR-TKI therapy
Radiologically documented disease progression after the first-line EGFR-TKI
MET amplification after disease progression following the first-line therapy
Having measurable lesions (in accordance with RECIST 1. 1 criteria)
United States Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Expected survival >12 weeks
Adequate bone marrow reserve or organ function
Female patients of childbearing potential must agree to use effective contraceptive methods from screening period to 4 weeks after discontinuation of the study drug
Male subjects should be willing to agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm
Being able to take or swallow the drug orally

Exclusion Criteria

Patients with positive T790M mutations
Previous treatment for c-MET
Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years
Previous use of systematic antitumor therapy other than EGFR-TKI for advanced NSCLC
Currently having received antiangiogenic therapy or traditional Chinese medicine with antitumor indicationextensive radiotherapy palliative local radiotherapy, a major surgery,or participated in other drug clinical trials and received corresponding tudy drug etc
Currently receiving the potent CYP3A4 inducers or potent CYP1A2 inhibitors within two weeks prior to the start of study treatment
Having not been sufficiently recovered from the toxicity and/or complication resulting from any interventional measure prior to the start of treatment
Clinically significant active infection, including but not limited to tuberculosis, human immunodeficiency virus (HIV) infection (positive HIV1/2 antibody)
Active hepatitis B, or active hepatitis C
Acute myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack
Known cancerous thrombus or deep vein thrombosis or uncontrollable hypertension despite the use of drugs
Mean resting corrected QT interval (QTcF) or Any important abnormality in rhythm
Presence of meningeal metastases, spinal cord compression or active brain metastases prior to the start of study treatment
Active gastrointestinal disease or other conditions significantly affecting the absorption, distribution, metabolism or excretion of oral study drug
Lack of compliance with participation in this clinical study or inability to comply with the limitations and requirements of the study, as judged by investigators
Known allergy to the active or inactive ingredient of Savolitinib or Osimertinib
Previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis and any active interstitial lung disease
Pregnant or breastfeeding women
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How to participate?

Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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