Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC

  • STATUS
    Recruiting
  • End date
    Jan 31, 2025
  • participants needed
    320
  • sponsor
    Hutchison Medipharma Limited
Updated on 7 December 2021
chemoradiotherapy
EGFR
c-MET
osimertinib
lung carcinoma

Summary

A Phase III Clinical Study on Savolitinib Combined with Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer

Description

A Multicenter, Randomized, Double-blind, Phase III Clinical Study to Evaluate the Efficacy and Safety of Savolitinib Combined with Osimertinib versus Placebo Combined with Osimertinib as the First-line Therapy for Patients with EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer

Details
Condition nsclc, Non-Small Cell Lung Cancer
Treatment Placebo, Savolitinib
Clinical Study IdentifierNCT05009836
SponsorHutchison Medipharma Limited
Last Modified on7 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Fully aware of this study and voluntary to sign the informed consent form, and being willing and able to comply with the study procedure
Age 18
In accordance with the Eighth Edition of TNM Staging of Lung Cancer by the International Association for the Study of Lung Cancer and American Joint Committee on Cancer, and patients with histologically or cytologically confirmed unresectable locally advanced (stage B/C), metastatic or recurrent (stage IV) NSCLC who are not suitable for radical concurrent chemoradiotherapy
Carrying two common EGFR mutations clearly related with the sensitivity to EGFR-TKI (i.e., exon 19 deletion, and L858R) and c-MET overexpression
Having measurable lesions (in accordance with RECIST 1.1 criteria)
ECOG Performance Status score 0 or 1, or Karnofsky score 80
Survival is expected to exceed 12 weeks
No any previous systematic antitumor therapy for advanced/metastatic disease
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 11. Male patients whose sexual partners are women of childbearing potential must use condoms during sexual intercourse during the study and within 6 months after discontinuation of study drug
Being able to take or swallow the drug orally

Exclusion Criteria

Previous treatment with EGFR inhibitors or MET inhibitors
Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years
Antitumor therapy within 2 weeks prior to the start of study treatment, including hormone therapy, biotherapy, immunotherapy or the traditional Chinese medicine for antitumor indication
Having received extensive radiotherapy (including radionuclide therapy, e.g., Sr-89) within 4 weeks prior to the start of study treatment or palliative local radiotherapy within one week prior to the start of study treatment, or the above adverse reactions of radiotherapy did not recover
Having received a major surgery within 4 weeks prior to the start of study treatment or a minor surgery (except biopsy, and venous catheterization) within one week prior to the start of study treatment
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
Uncontrollable hypertension despite the use of drugs
Mean resting corrected QT interval (QTcF) or Any important abnormality in rhythm
Patients whose known cancerous thrombus or deep vein thrombosis are stable for 2 weeks after receiving treatment with low molecular weight heparin (LMWH) or analogues with similar efficacy can be enrolled
Any important abnormality in rhythm
Presence of meningeal metastasis, spinal cord compression or active brain metastasis prior to the start of study treatment
Known allergy to the active or inactive ingredient of Savolitinib or Osimertinib
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
Having participated in other drug clinical trials and received the study drug within 3 weeks prior to the start of study treatment; 19. Known allergy to the active or inactive ingredient of Savolitinib or Osimertinib; 20. Previous history of interstitial lung diseases, drug-induced interstitial lung diseases, radiation pneumonitis requiring glucocorticoid therapy and any active interstitial lung diseases; 21. Pregnant and lactating women; 22. Any other disease, metabolic abnormality, physical examination abnormality or laboratory examination abnormality, certain disease or state, based on which there is a reason to suspect that the subject is not suitable for the study drug, or one condition that will affect intepretaton of the study results or put the subject at high risk
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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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