Clinical trial NCT02450591: Local Therapies for Oligometastatic Non-Small Cell Lung Cancer Harboring Sensitizing EGFR Mutations
Official title: Pilot Study of Local Therapies for Oligometastatic Non-Small Cell Lung Cancer Harboring Sensitizing EGFR Mutations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oligometastatic Lung Adenocarcinoma
Keywords: Sensitizing EGFR Mutations
Erlotinib
Surgery
Radiation Therapy
15-067
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will test if local therapies in addition to erlotinib can improve responses and delay the time until new treatment is required. This study will also collect blood samples for research blood tests.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed metastatic lung adenocarcinoma (recurrent or de novo) harboring sensitizing EGFR mutations (L858R, exon 19 deletion, G719A, L861Q, S768I, exon 19 insertions) with oligometastatic disease (≤5 discrete lesions of disease irrespective of location, inclusive of the primary lesion):
* all sites of disease must be amenable to definitive treatment with a local therapy (surgical resection, stereotactic radiosurgery, ablation and conventional radiation therapy) as determined by surgery, interventional radiology and radiation oncology
* all intrathoracic lymph nodes (including hilar, mediastinal, and supraclavicular nodal disease) are considered 1 discrete lesion.
* Each brain metastasis is included as a distinct lesion.
* Patients already started on erlotinib are eligible as long as their sites of disease are determined to be eligible for definitive local therapy by consensus of the principal investigators within 12 weeks of the patient first taking erlotinib.
* Lung adenocarcinoma histology confirmed at MSKCC.
* Available archived tissue to perform molecular analysis
* Patients without available archived tissue can have repeat biopsies to determine EGFR status as per standard clinical care guidelines
* Age 18 years or older
* Karnofsky Performance Status ≥ 70%
* Adequate bone marrow, liver and renal function, as specified below:
* Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
* Hemoglobin ≥ 8 g/dL
* Platelets ≥ 100 x 109/L
* Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's Syndrome)
* AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present
* Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal.
* For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment
* Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter

Exclusion Criteria:

* Treatment with erlotinib prior to developing metastatic disease
* Patients with activating but not sensitizing mutations (exon 20 insertions, EGFR T790M)
* Malignant pleural effusion or pleural disease
* Leptomeningeal disease
* Any site of disease that is not amenable to definitively local therapy including surgery or radiation therapy
* Women who are breastfeeding or pregnant
* Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment.
* Any medical co-morbidities that would preclude surgery or radiation therapy

Primary outcomes:
measure: Feasibility as Measured by at Least Five Patients Will Need to Complete Local Therapy.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memoral Sloan Kettering Cancer Center
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering at Mercy Medical Center
state: New York
city: Sleepy Hollow
country: United States
facility: Memoral Sloan Kettering Cancer Center at Phelps
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Helena Yu, MD
role: PRINCIPAL_INVESTIGATOR
References: