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

AstraZeneca AB0 sites172 target enrollmentApril 12, 2019

ConditionsEGFRm+ and MET+, Locally Advanced or Metastatic Non Small Cell Lung Cancer Therapeutic area: Diseases [C] - Cancer [C04]

DrugsTAGRISSO

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: EGFRm+ and MET+, Locally Advanced or Metastatic Non Small Cell Lung Cancer
Sponsor: AstraZeneca AB
Enrollment: 172
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 12, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

AstraZeneca AB

Eligibility Criteria

Inclusion Criteria

•\- Patients must be \=18 years of age (\=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 (including either exon 19 deletion and/or L858R) which is not amenable to curative therapy.
•\- Documented radiologic disease progression following treatment with osimertinib (osimertinib does not need to be the most recent therapy).
•\- MET amplification/high expression as determined by FISH (central), IHC (central) or NGS (local) testing on tumour tissue collected following progression on prior osimertinib treatment.
•\- Available tissue from a biopsy for MET analysis or willingness to collect additional tissue for central testing which fulfils the following requirements: obtained within 2 years of submission for MET analysis; sufficient tissue to meet the minimum tissue requirement defined in the current Laboratory Manual.
•\- At least 1 lesion, not previously irradiated, not biopsied during the screening period, that can be accurately measured at baseline as \=10 mm in the longest diameter (except lymph nodes which must have short axis \=15 mm) with CT or MRI which is suitable for accurate repeated measurements.
•\- Received at least 1 but no more than 3 prior lines of therapy (may include investigational therapy) in the locally advanced/metastatic setting.
•\- No more than one prior line of chemotherapy regimen
•\- A chemotherapy regimen including a programmed cell death\-1 (PD1\) or a PD1 ligand 1 (PD L1\) agent is acceptable, provided it was not the most recent line of therapy.
•\- No more than 2 prior lines of therapy containing EGFR TKI are acceptable

Exclusion Criteria

•\- Unresolved 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.
•\- 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 (eg, ulcerative disease, uncontrolled nausea, vomiting, diarrhoea Grade \=2, malabsorption syndrome or previous significant bowel resection).
•\- Any of the following cardiac diseases currently or within the last 6 months:
•Unstable angina pectoris
•Congestive heart failure (New York Heart Association \[NYHA] \=Grade 2\)
•Acute myocardial infarction
•Stroke or transient ischemic attack
•Uncontrolled hypertension (BP \=150/95 mmHg despite medical therapy).
•Mean resting correct 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.