A Phase 2 trial of durvalumab (MEDI4736) and tremelimumab with chemotherapy in metastatic EGFR mutant non-squamous non-small cell lung cancer (NSCLC) following progression on EGFR Tyrosine Kinase Inhibitors (TKIs) (ILLUMINATE).

niversity of Sydney0 sites100 target enrollmentOctober 23, 2018

ConditionsEGFR mutant advanced non small cell lung cancer.Cancer - Lung - Non small cell

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: EGFR mutant advanced non small cell lung cancer.
Sponsor: niversity of Sydney
Enrollment: 100
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 23, 2018

End Date

June 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversity of Sydney

Eligibility Criteria

Inclusion Criteria

•1\. Adults, aged 18 years and older (subjects from Taiwan must be 20 years or older) with histologically and/or cytologically confirmed non\-squamous non\-small cell lung cancer with EGFR mutation of Exon 19 deletion or Exon 21 L858R point mutation.
•Patients with co\-mutations are allowed as long as one of the mutation is either Exon 19 deletion or Exon 21 L858R point mutation
•2\. Disease that has progressed and either:
•(i) No evidence of EGFR T790M resistance mutation in both tissue re\-biopsy and plasma after EGFR tyrosine kinase inhibitor therapy (TKI)\*
•(ii) T790M mutation (detected in tissue re\-biopsy, plasma or both) and progression on 3rd generation EGFR TKI; patients are allowed to have one prior line of TKI therapy before 3rd generation TKI
•\*Patients who have progressed after first\-line or second\-line osimertinib where previous testing has not detected a denovo (first\-line) or acquired (second\-line) T790M resistance mutation are classified as T790M mutation negative.
•3\. Measurable disease according to RECIST 1\.1\.
•4\. ECOG performance status of 0 or 1\.
•5\. Adequate bone marrow function as defined below (within 14 days prior to registration and with values within the ranges specified below):
•Platelets greater or equal to 100 x 109/L

Exclusion Criteria

•1\. Prior immunotherapy with checkpoint inhibitors, including prior anti\-PD\-1/anti\-PD\-L1 or anti\-CTLA\-4 antibodies.
•2\. Prior chemotherapy for advanced NSCLC.
•For recurrent, incurable disease, prior adjuvant chemotherapy or concurrent chemotherapy and radiotherapy with curative intent is allowed, but must have been completed more than 6 months ago.
•3\. Prior EGFR TKI therapy
•Prior EGFR TKI (e.g., erlotinib, gefitinib, afatinib or osimertinib), including experimental TKI agents are allowed, but must be stopped 7 days prior to the first dose of study treatment. (If sufficient washout time has not occurred due to schedule or PK properties, an alternative appropriate washout time based on known duration and time to reversibility of drug related adverse events could be agreed upon by emailing the ILLUMINATE Study Team (illuminate@ctc.usyd.edu.au)).
•Patients treated with more than 2 lines of prior EGFR TKI are not permitted on the study.
•4\. Mixed histology with any small cell or squamous component.
•5\. Life expectancy of less than 3 months.
•6\. Current enrolment or participation in another clinical study with an unregistered investigational product during the last 12 months, unless it is an observational (non\-interventional) clinical study or during the follow\-up period of an interventional study must first be discussed with ILLUMINATE Study Team (illuminate@ctc.usyd.edu.au)) before study enrolment.
•7\. Any unresolved toxicity NCI CTCAE Grade greater or equal to 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.