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Non-small Cell Lung CancerPhase 1NCT01899989

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

A Phase 1 study testing Stereotactic Body Radiation Therapy (SBRT) and cisplatin or carboplatin-based in people with Non-small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Stereotactic Body Radiation Therapy (SBRT) and cisplatin or carboplatin-based
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
8 sitesUnited States
Study dates
5 Jul 2013to 2 Oct 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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).

Who cannot join

  • 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
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  • 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 exclusion criteria will be excluded from the functional MRI portion only:
  • Metallic implant,exclusions will be determined per institutional policies
  • Pacemaker and defibrillators are excluded
  • Stents etc. will be evaluated according to MSKCC policy
  • Unmanageable claustrophobia
  • High risk for nephrogenic systemic fibrosis

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Memorial Sloan Kettering Cancer Center at Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    East White Plains, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering at Mercy Medical Center

    Rockville Centre, New York

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

Other trials in United States

About this study

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.

Being tested
Stereotactic Body Radiation Therapy (SBRT), cisplatin or carboplatin-based
Keywords
Stereotactic Body Radiation Therapy (SBRT), Chemotherapy, 13-113
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Body Radiation Therapy (SBRT)Radiation

  • cisplatin or carboplatin-basedDrug

    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.

Study groups in NCT01899989
Study groupRoleWhat they receive
A) >5cm,Chemo eligible (closed to accrual)ExperimentalPatients will receive five fractions of either 8, 10, or 12 Gy to the gross tumor only. Following SBRT patients will be evaluated by their medical oncologist for consideration of adjuvant chemotherapy, starting 6-8 weeks post-RT. All patients will be followed for one year. Patients will be assessed for toxicity by their radiation oncologist at 4 to 6 weeks post-RT and during chemotherapy by their medical oncologist. Follow up after completion of all treatment will consist of CT chest scans at 6 and 12 months post-SBRT and toxicity assessments every 3 months from the end of SBRT for one year.
Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Drug: cisplatin or carboplatin-based
B) 3-5cm OR Chemo ineligibleExperimentalUsing intensity-modulated radiation therapy (IMRT) or volumetric arc therapy (VMAT), the choice of which is determined by the radiation oncologist, patients will be treated in < 5 fractions every other day. The total treatment dose will be between 45 and 54 Gy in < 5 fractions per standard of care. All patients will be followed for one year. Patients will be assessed for toxicity by their radiation oncologist at 4 to 6 weeks post-RT and during chemotherapy at the discretion of their medical oncologist. Follow up after completion of all treatment will consist of CT chest scans at 6 and 12 months post-SBRT and toxicity assessments every 3 months from the end of SBRT for one year. FDG PET/CT scans and Pulmonary Function Tests (PFTs) will be obtained at 3 months and 9 months after SBRT.
Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. maximum tolerated dose (Cohort A)

    standard 3+3 dose-escalation scheme

    Measured: 2 years

Secondary outcomes (2)

  1. ≥ grade 4 or persistent ≥ grade 3 late toxicities (Cohorts A & B)

    All patients will be assessed for toxicities according to CTCAE v 4.0 at least once during SBRT.

    Measured: ≥3 months post SBRT

  2. overall survival (Cohorts A & B)

    Response and progression will be evaluated per standard of care for radiographic progression on CT scans.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2013 (estimated)
  2. Study start5 Jul 2013
  3. Primary completion2 Oct 2024
  4. Study completion2 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01899989
Sponsor's protocol ID
13-113
Status last verified
Oct 2024
First submitted
8 Jul 2013
Last updated
4 Oct 2024
Results posted
No
Data monitoring committee
No

Publications

  • Rimner A, Gelblum DY, Wu AJ, Shepherd AF, Mueller B, Zhang S, Cuaron J, Shaverdian N, Flynn J, Fiasconaro M, Zhang Z, von Reibnitz D, Li H, McKnight D, McCune M, Gelb E, Gomez DR, Simone CB 2nd, Deasy JO, Yorke ED, Ng KK, Chaft JE. Stereotactic Body Radiation Therapy for Stage IIA to IIIA Inoperable Non-Small Cell Lung Cancer: A Phase 1 Dose-Escalation Trial. Int J Radiat Oncol Biol Phys. 2024 Jul 1;119(3):869-877. doi: 10.1016/j.ijrobp.2023.12.018. Epub 2023 Dec 26.

    PubMed 38154510

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Stereotactic Body Radiation Therapy (SBRT) and cisplatin or carboplatin-based in people with Non-small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

maximum tolerated dose (Cohort A) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01899989, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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