Clinical Trial Information
Protocol – ECOG – EA5182
Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.
- Patient must have a pathologically-confirmed diagnosis of non-squamous, non-small cell lung cancer (NSCLC).
- Patient must have advanced disease, defined as – either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease.
- Patient must have somatic activating sensitizing mutation in EGFR (e.g. but not limited to Exon 19 deletion, L858R, G709X, G719X, exon 19 insertions, L861Q, S768I). Patients with non-sensitizing mutations in EGFR (EGFR exon 20 insertions) are not eligible. Test results originating from a CLIA-certified or similarly accredited laboratory are acceptable; no specific assay is mandated. If there is any question as to whether an EGFR mutation is sensitizing, please contact the primary study team.
- Patient must not have received any prior treatment with an EGFR TKI or with an anti-VEGF agent.
- Patients that have received prior radiation therapy are eligible. Radiation (WBRT or stereotactic radiation) must have been completed at least two weeks prior to study registration.
- Patient must not have any risk factors for anti-VEGF administration, specifically, hemoptysis, active cardiovascular disease, uncontrolled hypertension, significant proteinuria (screening urine dipstick >3+) and tumor invading major blood vessels.
- Patient must have measurable disease.
- Patient must not have had any prior systemic treatment for metastatic disease.
- Patient must be ≥ 18 years of age.
- Patient must have an ECOG Performance status of 0 to 2.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Patient must not have had treatment with any investigational drug within five half-lives or 3 months (whichever is greater), prior to study initiation.
- Patient must not have any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of registration, with the exception of alopecia and grade 2 prior platinum-therapy–related neuropathy.
- Patient must not have mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value.
- Patient must not have 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.
- Patient must not have any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: potassium < LLN; magnesium < LLN; calcium < LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes.