Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This randomized phase II/III trial studies how well giving maintenance chemotherapy with or
without local consolidation therapy works in treating patients with stage IV non-small cell
lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium,
erlotinib hydrochloride, and gemcitabine work in different ways to stop the growth of tumor
cells, either by killing the cells, by stopping them from dividing, or by stopping them from
spreading. Local consolidation therapy such as radiation/stereotactic body radiation or
surgery may kill cancer cells left after initial treatment. Giving maintenance chemotherapy
and local consolidation therapy together may work better than maintenance chemotherapy alone
in treating patients with stage IV non-small cell lung cancer.
Phase
Phase 2
Funding Agency/Sponsor
National Cooperative Group
Disease
Thoracic Oncology
Enrollment Eligibility
Inclusion Criteria:
- Patients must have the psychological ability and general health that permits
completion of the study requirements and required follow up
- Women of childbearing potential and men who are sexually active should be willing and
able to use medically acceptable forms of contraception during the trial and for up to
180 days after completion of all treatment to prevent pregnancy or fathering a child.
- Pathologically proven diagnosis of NSCLC, with metastases (stage IV disease) present
prior to registration; this includes patients newly diagnosed with metastatic disease
or those initially diagnosed and treated for stage I-III NSCLC who ultimately develop
metastases
- Appropriate stage for study entry based on the following diagnostic workup:
- History/physical examination within 30 days prior to registration
- Imaging proof of limited metastatic disease and response to therapy/stable
disease, by at least CT chest through the adrenals or PET/CT within 30 days prior
to registration
- Zubrod performance status 0, 1, or 2 within 30 days prior to registration
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × upper limit of
normal (ULN) or ≤ 5 × ULN with metastatic liver disease
- Total bilirubin ≤ 1.5 × ULN
- Absolute neutrophil count (ANC) ≥ 500 cells/mm^3
- Creatinine clearance ≥ 45 mL/min/1.73 m^2 for patients with creatinine levels above
institutional normal
- Platelets ≥ 50,000 cells/mm^3
- Negative serum pregnancy test within one week prior to registration for females of
childbearing potential
- Patients must have received first-line/induction chemotherapy (4 cycles) and achieved
stable disease or a partial response
- Prior systemic chemotherapy as part of concurrent treatment approach for previously
diagnosed stage III NSCLC, as adjuvant therapy for previously resected NSCLC, or for
other previous cancers is permitted
- Prior radiotherapy for patients with brain metastases prior to enrollment is
acceptable
- Patients must have measurable disease at baseline and 3 or fewer discrete,
extracranial metastatic disease sites that are technically amenable to SBRT
- For de novo stage IV NSCLC patients (patients with metastatic disease at first
presentation), primary disease must be treatable with local therapy in the form of
SBRT or hypofractionated radiation; if the primary disease is found in the peripheral
or central lung parenchyma without nodal disease for instance, SBRT may be employed;
if primary disease is more advanced with involvement of the mediastinum (T4 tumor,
N1-N3 disease, etc.), these volumes should be technically treatable with
hypofractionated radiation
- If primary disease in the thoracic cavity was previously treated with local therapy in
the form of surgery, any local/regional disease recurrence should be technically
treatable with SBRT or hypofractionated radiation after induction systemic therapy
- Patients must be registered within 35 days of administration of the last dose of
first-line/induction systemic therapy
- The patient or a legally authorized representative must provide study-specific
informed consent prior to study entry
- Patients with brain metastases are eligible if these lesions have been previously
treated and the patients have no clinical or radiographic evidence of progression
prior to enrollment
Exclusion Criteria:
- Clinical or radiologic evidence of untreated and/or progressive brain metastases
- Cutaneous metastasis of NSCLC
- Metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph
nodes if not a candidate for surgery for these lesions
- Prior invasive malignancy (except non-melanomatous skin cancer, low or intermediate
risk prostate cancer, or in situ carcinoma of breast, oral cavity, skin, or cervix)
unless disease free for a minimum of one year
- Metastases located within 3 cm of previously irradiated (< 3Gy per fraction)
structures if if not a candidate for surgery for these lesions and if:
- Spinal cord previously irradiated to > 40 Gy
- Brachial plexus previously irradiated to > 50 Gy
- Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
- Brainstem previously irradiated to > 50 Gy
- Lung previously irradiated with prior V20 Gy > 35%
- Patients receiving targeted therapy (non-cytotoxic systemic therapy) for NSCLC in the
first-line setting
- If a patient has progressed in previous areas of primary disease that received
definitive doses of radiation, these patients would require re-irradiation in previous
high dose anatomic areas and are not eligible for this study
- Patients with malignant pleural effusions that do not resolve after first-line
systemic therapy; patients with pleural effusions that have become too small for
thoracentesis at the time of registration would be permitted on study, indicating a
significant response to first-line chemotherapy
- Patients with more than 3 discrete locations of extra-cranial metastatic disease after
first-line systemic therapy requiring more than 3 SBRT plans to cover these distinct
metastatic disease entities
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of
registration
- Patients who are pregnant or nursing
- Participation in any investigational drug study (excluding non-oncology and/or symptom
management studies) within 4 weeks prior to registration
- Known human immunodeficiency virus (HIV) positive with cluster of differentiation 4
(CD4) count < 200 cells/microliter; note that patients who are HIV positive are
eligible, provided they are under treatment with highly active antiretroviral therapy
(HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to
registration; note also that HIV testing is not required for eligibility for this
protocol
- For patients who received immunotherapy during induction, patients on chronic steroids
or who have active autoimmune disease for which they received systemic treatment in
the previous 2 years with corticosteroids, disease modifying agents, or
immunosuppressive drugs are not eligible. Replacement therapy (thyroxine, insulin or
physiological corticosteroid replacement for adrenal or pituitary insufficiency) is
allowed. Patients with active interstitial lung disease or who have a history of
pneumonitis for which they had received glucocorticoids are not eligible
- Prior bevacizumab therapy or other antiangiogenic therapy in first-line or planned
maintenance therapy (due to potential for increased complications from local therapy)