Phase 2 Completed N=24 Treatment

A Phase 1/2 Trial of Trametinib and Erlotinib in Patients With EGFR-Mutant Lung Adenocarcinomas and Acquired Resistance to Erlotinib

Lung Adenocarcinoma · Lung Cancer · Lung Cancer Metastatic · Lung Cancer Stage IV

Source: ClinicalTrials.gov NCT03076164 ↗

Enrolled (actual)

Serious AEs

25.0%

Results posted

Feb 2022

Primary outcomePrimary: Participants Response Rate — 11; 4; 8; 1 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants Response Rate	11; 4; 8; 1	—
PRIMARY Number of Participants Evaluated for Toxicities	24	—

Eligibility Criteria

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 /=2.6g/dL - Creatinine /=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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03076164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.