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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03076164
Other study ID # 15-098
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date March 1, 2017
Est. completion date December 18, 2020

Study information

Verified date June 2020
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety, tolerability and overall response rate of trametinib when given in combination with erlotinib in patients with Stage IV or recurrent lung adenocarcinoma that cannot be treated with curative intent.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date December 18, 2020
Est. primary completion date December 18, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pathologic evidence of advanced stage IV or recurrent lung adenocarcinoma reviewed at MSKCC - Somatic activating mutation in EGFR Radiographic progression during treatment with erlotinib. - Any number of prior chemotherapy regimens is permitted. - Measurable (RECIST 1.1) indicator lesion not previously irradiated - KPS >/= 70% - Age >18 years old - Must have undergone biopsy after development of acquired resistance to erlotinib with available archived tissue (equivalent of > 10 unstained slides) - Left ventricular Ejection Fraction >/= the lower limit of normal by ECHO or MUGA - Adequate organ function: - AST, ALT </= 2.5 x ULN - Total bilirubin </= 1.5 x ULN - Albumin>/=2.6g/dL - Creatinine < 1.5 x ULN OR calculated creatinine clearance >/=50mL/min - Absolute neutrophil count (ANC) >/= 1,200 cells/mm3 - Hemoglobin>/=9.0 g/dL - Platelets >/=100,000/mm3 Exclusion Criteria: - Patients with symptomatic brain metastasis requiring escalating doses of steroids - Patients with grade 2 or greater diarrhea prior to study initiation despite maximal medical management due to medications or a medical condition such as Crohn's disease or malabsorption - Pregnant or lactating women - Any type of systemic therapy (chemotherapy or experimental drugs) within 2 weeks of starting treatment on protocol except for a EGFR TKI - Patients who have received prior treatment with a MEK inhibitor - Any major surgery or extensive radiotherapy within 21 days of starting treatment on protocol. - A history of clinically significant interstitial lung disease or pneumonitis - Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study administration, New York Heart Association Class III or IV congestive heart failure, or symptomatic uncontrolled Arrythmias, prolonged corrected QT interval >480msec, treatment refractory hypertension, presence of a cardiac defibrillator - History of central serous retinopathy or retinal vein occlusion

Study Design


Intervention

Drug:
Trametinib
Trametinib 1.5mg once daily by mouth
Erlotinib
Erlotinib 75mg once daily by mouth

Locations

Country Name City State
United States Memoral Sloan Kettering Cancer Center Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack Commack New York
United States Memoral Sloan Kettering Westchester Harrison New York
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau Uniondale New York

Sponsors (2)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Participants Response Rate Response and progression of disease will be evaluated in this study using interval imaging every 8 weeks with CT scan of the chest and imaging of any other target lesion with response evaluated by RECIST 1.1. 2 years
Primary Number of Participants Evaluated for Toxicities Safety and tolerability will be evaluated by systematic and regular toxicity evaluations. Toxicity will be graded according to NCI CTCAE version 4.0. 2 years
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