A Phase II, multi-centre study, to evaluate the efficacy and safety of osimertinib treatment for patients with EGFR-mutated non-small cell lung cancer (NSCLC) with Brain or Leptomeningeal metastases

IFCT0 sites112 target enrollmentOctober 11, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: EGFR-mutated Non-small cell lung cancer (NSCLC) with Brain or Leptomeningeal metastases
Sponsor: IFCT
Enrollment: 112
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

October 11, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

IFCT

•1\.Patient with NSCLC (histological or cytological diagnosis) stage IV (8th UICC TNM edition, 2017\).
•2\.Patients with brain and/or leptomeningeal metastases.
•For cohort 1, the diagnosis of leptomeningeal metastasis requires either ? detection of cancer cell or EGFR mutation in the CSF, or ? presence of both clinical and neuro\-imaging findings typical of LM, according to EANO\-ESMO criteria.
•3\.Presence of an activating EGFR mutation. The following mutations are considered to be activating: L858R, exon 19 deletions, exon 19 insertions, L861Q, G719X. The inclusion of patients with other mutations should be discussed on a case\-by\-case basis with IFCT.
•The presence of co\-mutations on an oncogenic driver should be discussed with the IFCT before inclusion of the patient.
•4\.Testing for T790M mutation in circulating tumour DNA or tumour tissue sample at progression on the last treatment received before inclusion.
•5\.Maximum lines of anti\-cancer treatment received before inclusion:
•oFor Cohort 1, patients could have been previously treated with maximum 3 lines of anti\-cancer treatment.
•oFor cohort 2, patients could have been previously treated with maximum 1 line of anti\-cancer treatment.
•oFor cohorts 3 and 4, patients could have been previously treated with maximum 2 lines of anti\-cancer treatment. The line just before enrolment must be an EGFR TKI.

•1\.Small cell lung cancer histology (SCLC) or tumours with mixt histology including a SCLC component.
•2\.Previous treatment with osimertinib or another 3rd generation EGFR inhibitor.
•3\.Previous treatment with any EGFR TKI (cohort 2 only)
•4\.Brain progression requiring whole brain radiation without delay.
•5\.Local treatments (neurosurgical or stereotactic treatment) for brain metastases performed less than 2 weeks prior to enrolment.
•6\.Local brain treatment scheduled during study treatment.
•7\.Patient who received radiotherapy including the lung fields \= 4 weeks before enrolment or patient who has not recovered from radiotherapy\-induced toxicities. For all other body sites (including radiotherapy on thoracic vertebrae and ribs), radiotherapy \= 2 weeks before enrolment or who have not recovered from radiotherapy\-induced toxicities. Palliative radiotherapy for bone lesions \= 2 weeks before enrolment is authorised.
•8\.Any of the following cardiac criteria:
•\-Mean resting corrected QT interval (QTc) \> 470 msec using the screening clinic ECG machine derived QTc value
•\-Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block and second degree heart block).