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

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ClinicalTrials.gov Identifier: NCT05015608
Recruitment Status : Not yet recruiting
First Posted : August 20, 2021
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
Hutchison Medipharma Limited

Brief 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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Savolitinib + Osimertinib Drug: Pemetrexed + Cisplatin /Carboplatin Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Savolitinib + Osimertinib Versus Pemetrexed + Platinum in Treatment of Patients With NSCLC With MET Amplification
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : September 15, 2024
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Savolitinib + Osimertinib
Savolitinib orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks)
Drug: Savolitinib + Osimertinib
Subjects will receive Savolitinib orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks) until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.

Active Comparator: Pemetrexed combined with platinum
Pemetrexed combined with platinumon on Day 1 of 21day cycles (every 3 weeks)
Drug: Pemetrexed + Cisplatin /Carboplatin
Pemetrexed combined with platinumon on Day 1 of 21day cycles (every 3 weeks)




Primary Outcome Measures :
  1. PFS [ Time Frame: 5 months after the last patient enrolled ]
    Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).


Secondary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 5 months after the last patient enrolled ]
    Incidence and nature of treatment emergent adverse events (TEAE), the other safety variables including physical examination, vital signs and laboratory examinations

  2. The objective response rate of the tumor (ORR) [ Time Frame: 5 months after the last patient enrolled ]
    the incidence of confirmed complete response or partial response

  3. The disease control rate (DCR) [ Time Frame: 5 months after the last patient enrolled ]
    the incidence of complete response, partial response and stable disease

  4. Duration of Response (DoR) [ Time Frame: 5 months after the last patient enrolled ]
    the duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recorded

  5. Overall survival (OS) [ Time Frame: 5 months after the last patient enrolled ]
    the time from the date of randomization to the date of death (all causes)

  6. Time to Response (TTR) [ Time Frame: 5 months after the last patient enrolled ]
    the period from the date of randomization to the date when the criteria for complete response or partial response was first measured (first record shall prevail).

  7. PFS [ Time Frame: 5 months after the last patient enrolled ]
    Progression-free survival (PFS) using IRC as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Fully aware this study and voluntary to sign the informed consent form, and willing and able to comply with the study procedure;
  2. Age ≥ 18 and ≤75 years;
  3. 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;
  4. EGFR sensitive mutations prior to the first-line EGFR-TKI therapy;
  5. Radiologically documented disease progression after the first-line EGFR-TKI;
  6. MET amplification after disease progression following the first-line therapy;
  7. Having measurable lesions (in accordance with RECIST 1. 1 criteria);
  8. United States Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1;
  9. Expected survival >12 weeks;
  10. Adequate bone marrow reserve or organ function
  11. Female patients of childbearing potential must agree to use effective contraceptive methods from screening period to 4 weeks after discontinuation of the study drug;
  12. 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. ;
  13. Being able to take or swallow the drug orally.

Exclusion Criteria:

  1. Patients with positive T790M mutations;
  2. Previous treatment for c-MET;
  3. Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years.;
  4. Previous use of systematic antitumor therapy other than EGFR-TKI for advanced NSCLC;
  5. Currently having received antiangiogenic therapy or traditional Chinese medicine with antitumor indication、extensive radiotherapy 、palliative local radiotherapy, a major surgery,or participated in other drug clinical trials and received corresponding tudy drug etc;
  6. Currently receiving the potent CYP3A4 inducers or potent CYP1A2 inhibitors within two weeks prior to the start of study treatment;
  7. Having not been sufficiently recovered from the toxicity and/or complication resulting from any interventional measure prior to the start of treatment;
  8. Clinically significant active infection, including but not limited to tuberculosis, human immunodeficiency virus (HIV) infection (positive HIV1/2 antibody);
  9. Active hepatitis B, or active hepatitis C;
  10. Acute myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack;
  11. Known cancerous thrombus or deep vein thrombosis or uncontrollable hypertension despite the use of drugs;
  12. Mean resting corrected QT interval (QTcF) or Any important abnormality in rhythm;
  13. Presence of meningeal metastases, spinal cord compression or active brain metastases prior to the start of study treatment;
  14. Active gastrointestinal disease or other conditions significantly affecting the absorption, distribution, metabolism or excretion of oral study drug;
  15. 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;
  16. Known allergy to the active or inactive ingredient of Savolitinib or Osimertinib;
  17. Previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis and any active interstitial lung disease;
  18. Pregnant or breastfeeding women;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05015608


Contacts
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Contact: Lu Chen +86 21 20673000 ext 5014 Luc@hutch-med.com

Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
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Principal Investigator: Shun Lu, MD Shanghai Chest Hospital
Principal Investigator: Jie Wang, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT05015608    
Other Study ID Numbers: 2020-504-00CH3
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Pemetrexed
Osimertinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors