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New treatment option for EGFR Positive Non-small Cell Lung Cancer
Official title Osimertinib Combined With Savolitinib in the Treatment of NSCLC With Low Copy Number MET Amplification
ClinicalTrials.gov ID: NCT07322783
What this study is testing
What is • Drug: Savolitinib • Drug: Osimertinib Mesylate Tablets?
• Drug: Savolitinib • Drug: Osimertinib Mesylate Tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for egfr positive non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Osimertinib combined with savolitinib in the treatment of EGFR mutated osimertinib resistant NSCLC with low copy number MET amplification There are unmet medical needs in patients who resist to to osimertinib; savolitinib plus osimertinib shows high response rate and prolong progression-free survival in high copy number MET amplification patients. This study is to explore the efficacy and safety of the combination of savolitinib and osimertinib in osimertinb resistant patients with low copy number MET amplification.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 1\. Histologically or cytologically confirmed incurable advanced or metastatic non-small cell lung cancer who resistant to resistant to osimertinib...
- 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...
- 10\. Willingness to use contraception by a method that is deemed effective by the investigator by both males and female patients of child bearing...
- 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...
- 12\. Willingness and ability to comply with study procedures and follow-up examination.
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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:
The study team makes the final eligibility decision.
Where it's taking place
- Qingdao, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Qingdao, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.