Savolitinib for Treating Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Patients

  • STATUS
    Recruiting
  • End date
    Dec 9, 2024
  • participants needed
    163
  • sponsor
    Hutchison Medipharma Limited
Updated on 9 September 2021

Summary

Treating Non-small Cell Lung Cancer (NSCLC) Patients with MET exon 14mutations with Savolitinib

Description

This is a single-arm, multi-cohort, multi-center, open-label, phase IIIb clinical study. The objective is to evaluate the efficacy and safety of Savolitinib in the treatment of locally advanced or metastatic NSCLC patients with MET exon 14 mutations. The study involves a Screening Period, a Treatment Period and a Follow-up Period. It is planned that about 40 study sites will enroll 163 advanced or metastatic NSCLC patients with MET exon 14 mutations

Details
Condition Non Small Cell Lung Cancer Metastatic
Treatment Savolitinib
Clinical Study IdentifierNCT04923945
SponsorHutchison Medipharma Limited
Last Modified on9 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure
Age 18 years
Histologically diagnosed locally advanced or metastatic NSCLC with MET exon 14 mutation
Cohort 1: disease progression or intolerable toxicity after previous therapy with platinum-based chemotherapeutic regimen (for the patients who have received platinum-based adjuvant chemotherapy/radiotherapy, neoadjuvant chemotherapy/radiotherapy previously or radical radiochemotherapy for progressive disease, if the disease progression occurred < 6 months after the end of the last therapy, the patient belongs to failure after the first-line therapy); Cohort 2: no any previous systematic antitumor therapy for advanced diseases
Having measurable lesions (in accordance with RECIST 1.1 criteria)
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1, or Karnofsky performance status 80
Survival is expected to exceed 12 weeks
Adequate functionality in bone marrow, liver, kidney
Able to take or swallow the drug orally
Female patients of childbearing potential must agree to use effective contraceptive methods from screening period to 30 days after discontinuation of the study drug,The male patients whose sexual partners are women of childbearing age must use condom during sexual intercourse during the study and within 6 months after discontinuation of study drug

Exclusion Criteria

Having gene mutations sensitive to targeted drugs for EGFR, ALK and ROS1
Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years. Stage I malignant tumor after radical treatment for at least 3 years, except those considered by investigators to have small possibility of recurrence. Patients with radically treated carcinoma in situ (non-infiltrating) and skin cancer other than malignant melanoma can be enrolled
Having received antitumor therapy (including chemotherapy, hormone therapy, biotherapy, immunotherapy or traditional Chinese medicine for antitumor indication) within 3 weeks prior to the start of study treatment, or having received treatment with small molecular tyrosine kinase inhibitors (e.g., EGFR-TKI) within 2 weeks prior to the start of study treatment
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How to participate?

Step 1 Connect with a study center
What happens next?
  • 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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