Osimertinib Combined With Savolitinib in the Treatment of NSCLC With Low Copy Number MET Amplification
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQingdao Central Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
• Drug: Savolitinib • Drug: Osimertinib Mesylate Tablets
DrugOsimertinib 80 mg oral daily, savolitinib 400-600 mg (400mg for body weight \<60 kg, 600 mg for body weight \>60 kg) until disease progression or intolerable toxicities. Dose reduction of savolitinib can be from 600 mg to 400 mg and 400 mg to 200 mg.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Savolitinib plus osimertinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall response rate (ORR)
Overall response rate defined as the percentage of patients getting partial response and complete response after treatment
Time frame
the percentage of patients getting partial response and complete response, assessed at 2 month.Secondary outcomes
1
Progression-free survival (PFS)
Progression-free survival is defined as the time from the date of enrollment to the date of disease progression or patient death from any cause.
Time frame
From date of enrollment until the date of disease progression of patient death from any cause, assessed up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov