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A Study Comparing Savolitinib Plus Osimertinib vs Savolitinib Plus Placebo in Patients With EGFRm+ and MET Amplified Advanced NSCLC

NCT04606771

Description:

This study will compare the activity of the combination of savolitinib and osimertinib against the combination of savolitinib with placebo to osimertinib in patients with Epidermal Growth Factor Receptor Mutation Positive and MET amplified, locally advanced or metastatic non-small cell lung cancer who have progressed following treatment with osimertinib.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study Comparing Savolitinib Plus Osimertinib vs Savolitinib Plus Placebo in Patients With EGFRm+ and MET Amplified Advanced NSCLC
  • Official Title: A Multi-centre Phase II, Double-Blind, Randomised Study of Savolitinib in Combination With Osimertinib vs Savolitinib in Combination With Placebo in Patients With EGFRm+ and MET Amplified Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed Following Treatment With Osimertinib

Clinical Trial IDs

  • ORG STUDY ID: D5084C00009
  • SECONDARY ID: 2020-000813-33
  • NCT ID: NCT04606771

Conditions

  • Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
Osimertinib + SavolitinibArm A
Savolitinib + PlaceboArm B

Purpose

This study will compare the activity of the combination of savolitinib and osimertinib against the combination of savolitinib with placebo to osimertinib in patients with Epidermal Growth Factor Receptor Mutation Positive and MET amplified, locally advanced or metastatic non-small cell lung cancer who have progressed following treatment with osimertinib.

Detailed Description

      Resistance to EGFR-TKIs is a clinical problem. One of the mechanisms for resistance to
      osimertinib is amplification of the MET receptor tyrosine kinase, which activates downstream
      intracellular signalling independent of EGFR. This study will explore the individual
      contribution of savolitinib to MET mediated osimertinib resistance, by assessing the response
      to dual pathway blockade of EGFRm and MET to overcome MET mediated resistance to osimertinib
      versus inhibition of the MET pathway alone by investigating the efficacy of savolitinib plus
      osimertinib versus savolitinib plus placebo to osimertinib (hereafter referred to as placebo)
      in patients with EGFRm+ and MET amplified, locally advanced or metastatic NSCLC who have
      progressed following treatment with osimertinib. This is a multi centre, Phase II, double
      blind, randomised study.

      Patients will be randomised in a ratio of 1:1 to receive treatment with savolitinib once
      daily plus osimertinib once daily or savolitinib once daily plus placebo. Randomisation will
      be stratified according to the number ofprior lines of therapy (ie, osimertinib monotherapy
      as first line or ≥ second line [which includes patients who received osimertinib monotherapy
      before or after chemotherapy]). All patients confirmed as eligible will begin treatment on
      Day 1 with savolitinib plus osimertinib or savolitinib plus placebo. Treatment will continue
      once daily in 28 day cycles until either objective PD by RECIST 1.1 is assessed, unacceptable
      toxicity occurs, consent is withdrawn, or another discontinuation criterion is met.

      After progression, patients can be unblinded, and patients initially randomised to the
      savolitinib plus placebo arm may cross-over to open-label savolitinib plus osimertinib
      following investigator assessed objective PD to ensure that all patients enrolled may have
      the opportunity to receive the combination of savolitinib plus osimertinib.
    

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalSavolitinib 300 mg oral QD Osimertinib 80 mg oral QD
  • Osimertinib + Savolitinib
Arm BExperimentalSavolitinib 300 mg oral QD Placebo to Osimertinib 80mg oral QD
  • Savolitinib + Placebo

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must be ≥ 18 years of age at the time of signing the informed consent (≥ 20
             years of age in Japan). All genders are permitted

          -  Histologically or cytologically confirmed locally advanced or metastatic EGFRm+ NSCLC
             harbouring an EGFR mutation known to be associated with EGFR TKI sensitivity and that
             is permitted in the osimertinib national label (such as exon 19 deletion and/or
             L858R), which is not amenable to curative therapy.

          -  Documented radiologic PD following treatment with osimertinib (osimertinib does not
             need to be the most recent therapy).

          -  Have MET amplification as determined by central MET FISH testing on tumour specimen
             collected following progression on prior osimertinib treatment.

          -  At least measurable target lesion

          -  Patients must have received at least one but no more than 3 prior lines of therapy
             (including investigational therapy) in the locally advanced/metastatic setting.

          -  Adequate haematological, liver and renal function

          -  Eastern Cooperative Oncology Group/WHO performance status of 0 or 1 with no
             deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.

          -  Females of childbearing potential should be willing to use adequate contraceptive
             measures, should not be breastfeeding, and must have a negative pregnancy test.

          -  Male patients with a female partner of childbearing potential should be willing to use
             barrier contraception during the study and for 6 months following discontinuation of
             study intervention. Patients should refrain from donating sperm from the start of
             dosing until 6 months after discontinuing study intervention.

        Exclusion Criteria:

          -  Unresolved toxicities from any prior therapy greater than CTCAE Grade 1 at the time of
             starting study intervention with the exception of alopecia, haemoglobin ≥ 9 g/dL and
             Grade 2, prior platinum therapy related neuropathy.

          -  As judged by the investigator, active gastrointestinal disease or other condition that
             will interfere significantly with the absorption, distribution, metabolism, or
             excretion of oral therapy.

          -  Any of the following cardiac diseases currently or within the last 6 months:

               -  Unstable angina pectoris

               -  Congestive heart failure (NYHA Grade ≥ 2)

               -  Acute myocardial infarction

               -  Stroke or transient ischemic attack

               -  Uncontrolled hypertension (BP ≥ 150/95 mmHg despite medical therapy).

               -  Mean resting corrected QT interval (QTcF) > 470 msec for women and > 450 msec for
                  men at Screening, obtained from 3 ECGs using the screening clinic ECG machine
                  derived QTcF value.

               -  Any factors that may increase the risk of QTcF prolongation or risk of arrhythmic
                  events

               -  Any clinically important abnormalities in rhythm, conduction or morphology of
                  resting ECGs.

               -  Acute coronary syndrome

          -  Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89)
             administered ≤ 28 days or limited field radiation for palliation ≤ 7 days prior to
             starting study intervention or has not recovered from side effects of such therapy.

          -  Major surgical procedures ≤ 28 days of beginning study intervention or minor surgical
             procedures ≤ 7 days. No waiting is required following port-a-cath placement.

          -  As judged by the Investigator, any evidence of severe or uncontrolled systemic
             diseases, including renal transplant or active bleeding diatheses, which in the
             investigator's opinion makes it undesirable for the patient to enter the study or
             which would jeopardise compliance with the CSP.

          -  Active HBV (positive HBsAg result) or HCV. Viral testing is not required for
             assessment of eligibility for the study.

          -  Known serious active infection including, but not limited to, tuberculosis, or HIV
             (positive HIV 1/2 antibodies). Testing is not required for assessment of eligibility
             for the study.

          -  Presence of other active cancers, or history of treatment for invasive cancer, within
             the last 5 years. Patients with Stage I cancer who have received definitive local
             treatment at least 3 years previously, and are considered unlikely to recur are
             eligible. All patients with previously treated in situ carcinoma (ie, non-invasive)
             are eligible, as are patients with history of non-melanoma skin cancer.

          -  Spinal cord compression or brain metastases unless asymptomatic, stable and not
             requiring steroids for at least 2 weeks prior to start of study intervention.

          -  Past medical history of ILD, drug-induced ILD, radiation pneumonitis, which required
             steroid treatment, or any evidence of clinically active ILD.

          -  Prior or current treatment with a 3rd generation EGFR-TKI other than osimertinib.

          -  Prior or current treatment with savolitinib or another MET inhibitor (for example,
             foretinib, crizotinib, cabozantinib, onartuzumab, capmatinib).

          -  Patients who have received ≥ 4 lines of systemic therapy for NSCLC

          -  Any cytotoxic chemotherapy, investigational agents or other anti cancer drugs for the
             treatment of advanced NSCLC from a previous treatment regimen or clinical study within
             14 days prior to the first dose of study intervention with the exception of
             monotherapy osimertinib which may continue uninterrupted during screening.

          -  Patients currently receiving (or unable to stop use prior to receiving the first dose
             of study intervention) medications or herbal supplements known to be strong inducers
             of CYP3A4 or strong inhibitors of CYP1A2, or CYP3A4 substrates which have a narrow
             therapeutic range within 2 weeks of the first dose of study intervention (3 weeks for
             St John's Wort) will be excluded. All patients must try to avoid concomitant use of
             any medications, herbal supplements and/or ingestion of foods with known inducer
             effects on CYP3A4 during the study and for 3 months later the last dose intake.

          -  Participation in another clinical study with a cytotoxic, investigational product, or
             other anti cancer drug for the treatment of advanced NSCLC if received study
             intervention from that study within 14 days of the first dose of study intervention.

          -  Known hypersensitivity to the active or inactive excipients of osimertinib or
             savolitinib or drugs with a similar chemical structure or class.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:The primary analysis will occur 6 months after the last patient is randomised.
Safety Issue:
Description:ORR will be performed based on Investigator assessment of disease progression by RECIST 1.1.

Secondary Outcome Measures

Measure:Progression-free Survival (PFS)
Time Frame:The primary analysis will occur 6 months after the last patient is randomised.
Safety Issue:
Description:PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by the investigator or death due to any cause.
Measure:Duration of Response (DoR)
Time Frame:The primary analysis will occur 6 months after the last patient is randomised.
Safety Issue:
Description:DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 as assessed by the investigator or death in the absence of disease progression.
Measure:Tumour Size Assessment (TSA)
Time Frame:The primary analysis will occur 6 months after the last patient is randomised.
Safety Issue:
Description:TSA is defined as the percentage change from baseline in TLs at 12 weeks per RECIST 1.1 as assessed by the investigator.
Measure:Overall Survival (OS)
Time Frame:The primary analysis will occur 6 months after the last patient is randomised. the final analysis will occur at the earlier of 18 months after the last patient is randomised or when 70% of patients have progressed or died.
Safety Issue:
Description:OS is defined as time from randomisation until the date of death due to any cause.
Measure:Objective Response Rate (ORR)
Time Frame:The primary analysis will occur 6 months after the last patient is randomised. the final analysis will occur at the earlier of 18 months after the last patient is randomised or when 70% of patients have progressed or died.
Safety Issue:
Description:Objective response rate in patients who cross over after progression on savolitinib plus placebo, defined as the proportion of patients with measurable disease who have a CR or PR as determined by the investigator at the local site per RECIST 1.1.
Measure:Progression Free Survival
Time Frame:The primary analysis will occur 6 months after the last patient is randomised. the final analysis will occur at the earlier of 18 months after the last patient is randomised or when 70% of patients have progressed or died.
Safety Issue:
Description:Progression free survival in patients who cross over after progression on savolitinib plus placebo, defined as time from the first dose in the cross over period until progression per RECIST 1.1 as assessed by the investigator or death due to any cause.
Measure:Duration of Response
Time Frame:The primary analysis will occur 6 months after the last patient is randomised. the final analysis will occur at the earlier of 18 months after the last patient is randomised or when 70% of patients have progressed or died.
Safety Issue:
Description:Duration of response in patients who cross over after progression on savolitinib plus placebo, defined as the time from the date of first documented response during the cross-over period until date of documented progression per RECIST 1.1 as assessed by the investigator or death in the absence of disease progression.
Measure:Tumour Size Assessment
Time Frame:The primary analysis will occur 6 months after the last patient is randomised. the final analysis will occur at the earlier of 18 months after the last patient is randomised or when 70% of patients have progressed or died.
Safety Issue:
Description:Tumour size assessment in patients who cross over after progression on savolitinib plus placebo, defined as the percentage change from baseline in TLs at 12 weeks per RECIST 1.1 as assessed by the investigator.
Measure:Total clearance in EGFR mutations at 6-weeks after therapy initiation (percentage and absolute change from baseline in EGFR mutation allele frequencies).
Time Frame:The primary analysis will occur 6 months after the last patient is randomised.
Safety Issue:
Description:To determine the prevalence of ctDNA clearance after savolitinib plus osimertinib or savolitinib plus placebo treatment in this patient population
Measure:Plasma concentrations of savolitinib, osimertinib and their metabolites, (M2 and M3 for savolitinib; AZ5104 for osimertinib)
Time Frame:Cycle 1, Day 1: Pre-dose and 1 and 3 hours post-dose; Cycle 2, Day 1: Pre-dose and 1 and 3 hours post-dose; Cycle 3, Day 1: Pre dose and 1, 3, 4, and 6 hours post-dose; Cycles 6 and 11, Day 1: Pre-dose only. (Each Cycle is 28 days).
Safety Issue:
Description:To evaluate the PK of savolitinib and osimertinib.
Measure:Time dependency of the PK of savolitinib, osimertinib and their metabolites, (M2 and M3 for savolitinib; AZ5104 for osimertinib)
Time Frame:C3h Cycle 2 Day 1/C3h Cycle 1 Day 1; Cpre-dose Cycle 3 Day 1/Cpre-dose Cycle 2 Day 1; Cpre-dose Cycle 6 Day 1/Cpre-dose Cycle 2 Day 1; Cpre-dose Cycle 11 Day 1/Cpre-dose Cycle 2 Day 1. (Each Cycle is 28 days)
Safety Issue:
Description:To evaluate the PK of savolitinib and osimertinib.
Measure:AUCss of savolitinib, osimertinib and their metabolites, (M2 and M3 for savolitinib; AZ5104 for osimertinib)
Time Frame:Cycle 3, Day 1 (Each Cycle is 28 days)
Safety Issue:
Description:To evaluate the PK of savolitinib and osimertinib.
Measure:Cssmax of savolitinib, osimertinib and their metabolites, (M2 and M3 for savolitinib; AZ5104 for osimertinib)
Time Frame:Cycle 3, Day 1 (Each Cycle is 28 days)
Safety Issue:
Description:To evaluate the PK of savolitinib and osimertinib.
Measure:Tssmax of savolitinib, osimertinib and their metabolites, (M2 and M3 for savolitinib; AZ5104 for osimertinib)
Time Frame:Cycle 3, Day 1 (Each Cycle is 28 days)
Safety Issue:
Description:To evaluate the PK of savolitinib and osimertinib.
Measure:CLss/F of savolitinib, osimertinib and their metabolites, (M2 and M3 for savolitinib; AZ5104 for osimertinib)
Time Frame:Cycle 3, Day 1 (Each Cycle is 28 days)
Safety Issue:
Description:To evaluate the PK of savolitinib and osimertinib.
Measure:Number and percentage of subjects with adverse events (AEs) in different categories: All AEs
Time Frame:Continuous collection from First dose until study termination, on average 12 months
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number and percentage of subjects with adverse events (AEs) in different categories: Serious AEs
Time Frame:Continuous collection from First dose until study termination, on average 12 months
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number and percentage of subjects with adverse events (AEs) in different categories: Causally related AEs
Time Frame:Continuous collection from First dose until study termination, on average 12 months
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number and percentage of subjects with adverse events (AEs) in different categories: Discontinuations due to AEs
Time Frame:Continuous collection from First dose until study termination, on average 12 months
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number and percentage of subjects with adverse events (AEs) in different categories: Deaths
Time Frame:Continuous collection from First dose until study termination, on average 12 months
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Albumin
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Alkaline phosphatase
Time Frame:Screening, weekly for first 5, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in ALT
Time Frame:Screening, weekly for first 10, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Amylase
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in AST
Time Frame:Screening, weekly for first 10 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation(an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Total bilirubin
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Total Calcium
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Creatinine
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Glucose
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation(an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Magnesium
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Sodium
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Potassium
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Total Protein
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in BUN or urea
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Lactate dehydrogenase
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Haematocrit
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Haemoglobin
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Leucocyte cell count
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Platelet count
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Red blood cell count
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Reticulocytes
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Neutrophil count
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Lymphocyte count
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.
Measure:Number of subjects with at least one treatment emergent change in laboratory parameters in Eosinophil count
Time Frame:Screening, weekly for first 5 weeks, then Day 1 of every cycle (each Cycle is 28 days) until treatment discontinuation (an average of 1 year)
Safety Issue:
Description:To evaluate the safety and tolerability of savolitinib plus osimertinib or savolitinib plus placebo.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AstraZeneca

Trial Keywords

  • Locally
  • Advanced
  • Metastatic
  • Carcinoma
  • Non-Small Cell Lung Cancer
  • Osimertinib
  • Tagrisso
  • Savolitinib
  • MET
  • EGFR

Last Updated

December 2, 2020