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Clinical Trials/CTRI/2019/08/020845
CTRI/2019/08/020845
Recruiting
Phase 2

A Phase II Single Arm Study Assessing the Efficacy of Osimertinib in Combination with Savolitinib in Patients with EGFRm positive and MET positive Locally Advanced or Metastatic Non Small Cell Lung Cancer who have Progressed Following Treatment with Osimertinib The SAVANNAH Study - SAVANNAH

AstraZeneca AB0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Sponsor
AstraZeneca AB
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1 Patients must be more than equal to 18 years of age
  • •All genders are permitted
  • •2 Histologically or cytologically confirmed locally advanced or metastatic EGFRm positive NSCLC harbouring an EGFR mutation known to be associated with EGFR TKI sensitivity including either exon 19 deletion and/or L858R which is not amenable to curative therapy.
  • •3 Documented radiologic disease progression following treatment with osimertinib
  • •Osimertinib does not need to be the most recent therapy
  • •4 MET amplification or high expression as determined by FISH central IHC central or NGS local testing on tumour tissue collected following progression on prior osimertinib treatment
  • •5 Available tissue from a recent biopsy for MET analysis or willingness to collect additional tissue for central testing
  • •6 At least 1 lesion not previously irradiated not biopsied during the screening period that can be accurately measured at baseline as more than equal to 10 mm in the longest diameter except lymph nodes which must have short axis more than equal to 15 mm with CT or MRI which is suitable for accurate repeated measurements
  • •7 Received at least 1 but no more than 3 prior lines of therapy may include investigational therapy in the locally advanced/metastatic setting
  • •8 No more than one prior line of chemotherapy regimen

Exclusion Criteria

  • •1Unresolved toxicities from any prior therapy greater than Common Terminology Criteria for Adverse Events CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 prior platinum therapy related neuropathy
  • •2As judged by the investigator active gastrointestinal disease or other condition that will interfere significantly with the absorption distribution metabolism or excretion of oral therapy example ulcerative disease uncontrolled nausea vomiting diarrhoea Grade more than equal to 2 malabsorption syndrome or previous significant bowel resection
  • •3Any of the following cardiac diseases currently or within the last 6 months
  • •Unstable angina pectoris Congestive heart failure New York Heart Association NYHA more than equal to Grade 2 Acute myocardial infarction Stroke or transient ischemic attack Uncontrolled hypertension BP more than equal to 150 by 95 mmHg despite medical therapy. Mean resting correct QT interval QTcF more than 470 msec for women and more than 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 such as heart failure chronic hypokalaemia not correctable with supplements congenital or familial long QT syndrome family history of unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause Torsade de Pointes
  • •Any clinically important abnormalities in rhythm conduction or morphology of resting ECGs example complete left bundle branch block third degree heart block second degree heart block P\-R interval more than 250 msec
  • •Acute coronary syndrome
  • •4Wide field radiotherapy including therapeutic radioisotopes such as strontium 89 administered less than equal to 28 days or limited field radiation for palliation less than equal to 7 days prior to starting study drug or has not recovered from side effects of such therapy
  • •5Major surgical procedures less than equal to 28 days of beginning study drug or minor surgical procedures less than equal to 7 days
  • •6Evidence of severe or uncontrolled systemic diseases including renal transplant active bleeding diatheses or uncontrolled hypertension which in the investigators opinion makes it undesirable for the patient to participate

Outcomes

Primary Outcomes

Not specified

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