Clinical Trials /

Local Therapies for Oligometastatic Non-Small Cell Lung Cancer Harboring Sensitizing EGFR Mutations

NCT02450591

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 15-067
  • NCT ID: NCT02450591

Conditions

  • Oligometastatic Lung Adenocarcinoma

Interventions

DrugSynonymsArms
ErlotinibOligometastatic Non-Small Cell Lung Cancer

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Oligometastatic Non-Small Cell Lung CancerExperimentalPatients will be placed on EGFR-TKI for their metastatic EGFR-mutant stage IV oligometastatic disease. All patients will undergo induction TKI for 12 weeks. At the conclusion of 12 weeks on erlotinib, patients without disease progression [partial response (PR) or stable disease (SD)] will undergo definitive local treatment to all remaining sites of disease. After local therapy, erlotinib will be resumed until progression of disease (POD) by RECIST criteria. All assessments completed during the 12 week TKI induction phase are to be performed per protocol with a ± 7 day window.
  • Erlotinib

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Feasibility as Measured by at Least Five Patients Will Need to Complete Local Therapy.
Time Frame:2 years
Safety Issue:
Description:At least five patients will need to complete local therapy within 2 years of the study being open to accrual for the primary endpoint to be met.

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Sensitizing EGFR Mutations
  • Erlotinib
  • Surgery
  • Radiation Therapy
  • 15-067

Last Updated

May 21, 2018