Osimertinib plus savolitinib for EGFR-mutated lung cancer with low-level MET amplification

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm, multicenter phase 2 trial enrolling patients with EGFR-mutant NSCLC who have progressed on osimertinib and have low-level MET amplification (MET copy number <5 by NGS or FISH). Participants receive osimertinib 80 mg daily plus savolitinib 400–600 mg daily with weight-based dosing and predefined dose-reduction rules for savolitinib. The trial focuses on objective response rate and safety, with progression-free survival and tolerability as important secondary outcomes. Treatment continues until disease progression or unacceptable toxicity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Histologically or cytologically confirmed incurable advanced or metastatic non-small cell lung cancer who resistant to resistant to osimertinib, chemo-immunotherapy or anti-angiogenesis.

  2\. At least 1 measurable lesion (RECIST 1.1). 3. MET amplification copy number below 5 by FISH. 4. Male or female patients age ≥18 years. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. 6. Estimated OS ≥3 months. 7. Adequate hematologic and bone marrow functions. 8. Adequate renal and liver function. 9. Had recovered from all toxicities related to prior anticancer therapies to grade ≤ 2, except for patients with grade 2 nausea/vomiting and/or grade 2 diarrhea despite optimal supportive therapy who will not be allowed to participate in the study.

  10\. Willingness to use contraception by a method that is deemed effective by the investigator by both males and female patients of child bearing potential (postmenopausal women must have been amenorrhea for at least 12 months to be considered of non-childbearing potential) and their partners throughout the treatment period and for at least three months following the last dose of study drug.

  11\. Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures).

  12\. Willingness and ability to comply with study procedures and follow-up examination.

Exclusion13. Any of the following cardiac criteria: screening period resting period QTC \> 470 milliseconds (clinical electrocardiograph report value; if a single time\> 470 milliseconds, take the average of 3 inspections); rhythm of resting electrocardiogram (ECG), any clinically important abnormality of conduction or morphology (e.g., complete left bundle branch block, Grade 3 heart block, Grade 2 heart block); family history of congenital long QT prolongation syndrome or long QT syndrome.

14\. Evidence of any serious or uncontrolled systemic disease; various chronic active infections such as hepatitis B (HBV-DNA ≥ 104 copy number/ml or 2000 IU/ml), hepatitis C and HIV; uncontrollable Hypertensive patients (requires 2 or more drugs to control blood pressure); unstable angina; angina pectoris within 3 months prior to study; congestive heart failure (NYHA class II or higher); myocardial infarction (NSTEMI or STEMI) history in 6 months before study enrollment; severe arrhythmia requiring medical attention; severe liver, kidney, gastrointestinal or metabolic diseases.

15\. Patients who are unable to taking drugs 16. Other malignancies need treatment; except effectively treated skin basal cell carcinoma, cutaneous squamous cell carcinoma, and/or effectively resected orthotopic cervical cancer and/or breast cancer.

17\. Female patients during pregnancy or lactation. 18. Previous allergies or intolerance to treatment with osimertinib and savolitinib.

19\. Any other condition or circumstance of that would, in the opinion of the investigator, make the patient unsuitable for participation in the study.

Criteria:

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Where it's running

• Qingdao Central Hospital
  Qingdao, China Recruiting

Study contacts

• Study coordinator: youxin Ji, md, phD
• Email: kevinji78@yahoo.com
• Phone: 1718865657

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Izalontamab Brengitecan with Osimertinib in EGFR-mutant NSCLC: first-line versus standard options

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.