Non-small Cell Lung Cancer
Conditions
Keywords
Stereotactic Body Radiation Therapy (SBRT), Chemotherapy, 13-113
Brief summary
The purpose of this study is to determine if the use of exploratory immunologic biomarkers, functional MRI images can serve as early predictors for response of NSCLC. It also will provide important information on the perceived side effects from a patient perspective. Patients may participate if they have tumors ≥3 cm without lymph node involvement (for which chemotherapy is not part of the standard of care). Patients will only receive stereotactic body radiation therapy (SBRT) per standard dose guidelines.
Interventions
RADIATIONStereotactic Body Radiation Therapy (SBRT)
DRUGcisplatin or carboplatin-based
Standard chemotherapy with a histology-selected cisplatin or carboplatin-based doublet will be administered intravenously as adjuvant therapy. Gemcitabine will be used for squamous cell carcinomas and pemetrexed will be used for non-squamous non-small cell lung cancer. Cisplatin or carboplatin will be used in combination with the histology-selected agent. The choice of cisplatin or carboplatin will be at the discretion of the treating medical oncologist.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients: * Histologically confirmed non-small cell lung cancer * Medically or technically inoperable as per thoracic surgeon or patient's preference not to undergo surgical resection * Age ≥ 18 years * Women of childbearing potential must have a negative blood pregnancy test * Ability to provide written informed consent Cohort A: * Stage IIA-IIIA (TanyN1M0 or T2b-4N0M0) Selected patients with single station N2 nodal involvement in close proximity to the primary tumor target may be considered eligible at the discretion of the PI if all normal tissue guidelines can be met * Eligible for chemo-therapy * Karnofsky Performance Status ≥70% * Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter * Patients must show adequate organ function as defined by: * Calculated creatinine clearance ≥40 mL/min for patients receiving pemetrexed (by Cockcroft-Gault) * Calculated creatinine clearance ≥30 mL/min for patients receiving gemcitabine or paclitaxel (by Cockcroft-Gault) Total bilirubin less than 1.5 x ULN (unless known Gilbert's disease) * AST and ALT less than 3 x ULN * Absolute neutrophil count greater than 1500/mm3 * Platelet count greater than 100,000/mm3 Cohort B: * T2a-4N0M0 who are not candidates for cohort A or who will not be treated with chemotherapy (due to patient preference or at the recommendation of the treating physician).
Exclusion criteria
All patients: * Prior radiation therapy to the lungs * Prior surgery or chemotherapy for this presentation of lung cancer (history of prior lung cancer that has been treated and deemed inactive by the clinician is acceptable. Recurrent tumors may be treated on protocol as long as SBRT will be the definitive treatment.) * N2-3 lymph node involvement based on PET/EBUS-FNA/mediastinoscopy (Any N2 disease that is more than just minimal single station involvement is excluded) * Direct tumor extension into including aorta or pulmonary artery * Chronic corticosteroid use equivalent to ≥ prednisone 10 mg daily Prior treatment with a CD137 agonist, ipilimumab, or the CTLA-4 inhibitor, or PD-1/PDL-1 inhibitor * Unstable congestive heart failure Cohort A: * Continuous oxygen use Patients meeting the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maximum tolerated dose (Cohort A) | 2 years | standard 3+3 dose-escalation scheme |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ≥ grade 4 or persistent ≥ grade 3 late toxicities (Cohorts A & B) | ≥3 months post SBRT | All patients will be assessed for toxicities according to CTCAE v 4.0 at least once during SBRT. |
| overall survival (Cohorts A & B) | 2 years | Response and progression will be evaluated per standard of care for radiographic progression on CT scans. |
Countries
United States
Outcome results
None listed