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CompletedPhase 1NCT01899989
Official study title

Stereotactic Body Radiation Therapy for Inoperable Locally-advanced Non-small Cell Lung Cancer

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedStereotactic Body Radiation Therapy (SBRT) and cisplatin or carboplatin-based

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 4, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?Memorial Sloan Kettering Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Memorial Sloan Kettering Cancer Center
Interventions being studied
Radiation: Stereotactic Body Radiation Therapy (SBRT); Drug: cisplatin or carboplatin-based
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Early-stage or resectable→
Treatment approach
Chemotherapy→Radiation therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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).
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Memorial Sloan Kettering Cancer Center at Basking RidgeBasking Ridge, New Jersey
  • Memorial Sloan Kettering MonmouthMiddletown, New Jersey
  • Memorial Sloan Kettering BergenMontvale, New Jersey
  • Memorial Sloan Kettering Cancer Center @ SuffolkCommack, New York
  • Memorial Sloan Kettering WestchesterEast White Plains, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Memorial Sloan Kettering at Mercy Medical CenterRockville Centre, New York
  • Memorial Sloan Kettering NassauUniondale, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 4, 2024. Always confirm current availability with the study team.

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