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A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)

Primary Purpose

Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non-small Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
L-SABR
Anti-PD-(L)1 based immunotherapy
Platinum based chemotherapy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring non small cell lung cancer, Non Small Cell Lung Cancer Metastatic, Non-small Cell Carcinoma, liver stereotactic ablative radiotherapy, L-SABR, NSCLC, NSCLC Stage IV, Memorial Sloan Kettering Cancer Center, 22-368

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Be greater than 18 years of age on day of signing informed consent. Have a histologically confirmed diagnosis of stage IV NSCLC (includes patients who have progressed on durvalumab for Stage III NSCLC) without known mutations in epidermal sensitizing growth factor (EGFR) or BRAF or rearrangements in ALK (anaplastic lymphoma kinase) or ROS-1. Newly diagnosed metastatic non-small cell lung cancer (NSCLC), including both de novo and secondary metastatic disease, with liver metastases Plan to initiate standard of care anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy Have a performance status of 0-2 on the ECOG Performance Scale. Liver function tests: Total Bilirubin ≤ 1.5 x ULN AST/ ALT ≤ 5 x ULN Eligible for L- SABR to all liver metastases. Eligible for or plan to initiate standard of care therapy with anti-PD(L)-1 therapy alone or anti-PD(L)-1 therapy in combination with platinum-based chemotherapy, up to cycle 3. Patients with known HIV are eligible provided they are under treatment with effective anti-retroviral therapy with CD4 >200 cells/microliter ≤ 28 days prior to registration Exclusion Criteria: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included. Patients with prior external beam radiation therapy to the liver. Patients with known active Hepatitis B or Hepatitis C. Patients with immunosuppression including pharmacological immunosuppression with chronic steroids or immune modulators like cyclosporin or methotrexate and patients with active autoimmune disease. Patients who are pregnant or breastfeeding Men or women not using effective contraception.

Sites / Locations

  • Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (All protocol activities)Recruiting
  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Westchester (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (All protocol activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

L-SABR Arm

Control Arm

Arm Description

Participants randomized to the experimental arm will continue with standard of care treatment but will also undergo radiation simulation for L-SABR/Liver Stereotactic Ablative Radiation Therapy.

Participants randomized to the control arm will be treated according to the standard of care.

Outcomes

Primary Outcome Measures

Median progression-free survival
Primary outcomes is to determine if L-SABR, when added to first line standard of care anti-PD-(L)1 based immunotherapy +/- chemotherapy, can improve median progression-free survival (PFS) in patients with metastatic NSCLC involving the liver.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2022
Last Updated
October 20, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05657873
Brief Title
A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)
Official Title
A Phase II Trial of Hepatic Ablation of Metastases to Modulate and Enhance Immunotherapy Response (HAMMER) in NSCLC
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2022 (Actual)
Primary Completion Date
December 9, 2025 (Anticipated)
Study Completion Date
December 9, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
The purpose of this study is to see whether adding liver stereotactic ablative radiotherapy/L-SABR to standard drug therapy is better than standard drug therapy alone for people with metastatic non-small cell lung cancer/NSCLC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non-small Cell Carcinoma, NSCLC, NSCLC Stage IV
Keywords
non small cell lung cancer, Non Small Cell Lung Cancer Metastatic, Non-small Cell Carcinoma, liver stereotactic ablative radiotherapy, L-SABR, NSCLC, NSCLC Stage IV, Memorial Sloan Kettering Cancer Center, 22-368

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
L-SABR Arm
Arm Type
Experimental
Arm Description
Participants randomized to the experimental arm will continue with standard of care treatment but will also undergo radiation simulation for L-SABR/Liver Stereotactic Ablative Radiation Therapy.
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Participants randomized to the control arm will be treated according to the standard of care.
Intervention Type
Radiation
Intervention Name(s)
L-SABR
Other Intervention Name(s)
Liver Stereotactic Ablative Radiation Therapy
Intervention Description
L-SABR will be delivered in a week during which the patient receives no chemotherapy. L-SABR can be on the same week or even day as anti-PD-(L)1 therapy.
Intervention Type
Biological
Intervention Name(s)
Anti-PD-(L)1 based immunotherapy
Other Intervention Name(s)
Standard of Care
Intervention Description
Standard of care treatment (anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy
Intervention Type
Drug
Intervention Name(s)
Platinum based chemotherapy
Other Intervention Name(s)
Standard of Care
Intervention Description
Standard of care treatment (anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy
Primary Outcome Measure Information:
Title
Median progression-free survival
Description
Primary outcomes is to determine if L-SABR, when added to first line standard of care anti-PD-(L)1 based immunotherapy +/- chemotherapy, can improve median progression-free survival (PFS) in patients with metastatic NSCLC involving the liver.
Time Frame
up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be greater than 18 years of age on day of signing informed consent. Have a histologically confirmed diagnosis of stage IV NSCLC (includes patients who have progressed on durvalumab for Stage III NSCLC) without known mutations in epidermal sensitizing growth factor (EGFR) or BRAF or rearrangements in ALK (anaplastic lymphoma kinase) or ROS-1. Newly diagnosed metastatic non-small cell lung cancer (NSCLC), including both de novo and secondary metastatic disease, with liver metastases Plan to initiate standard of care anti-PD-(L)1 based immunotherapy +/- platinum based chemotherapy Have a performance status of 0-2 on the ECOG Performance Scale. Liver function tests: Total Bilirubin ≤ 1.5 x ULN AST/ ALT ≤ 5 x ULN Eligible for L- SABR to all liver metastases. Eligible for or plan to initiate standard of care therapy with anti-PD(L)-1 therapy alone or anti-PD(L)-1 therapy in combination with platinum-based chemotherapy, up to cycle 3. Patients with known HIV are eligible provided they are under treatment with effective anti-retroviral therapy with CD4 >200 cells/microliter ≤ 28 days prior to registration Exclusion Criteria: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included. Patients with prior external beam radiation therapy to the liver. Patients with known active Hepatitis B or Hepatitis C. Patients with immunosuppression including pharmacological immunosuppression with chronic steroids or immune modulators like cyclosporin or methotrexate and patients with active autoimmune disease. Patients who are pregnant or breastfeeding Men or women not using effective contraception.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Romesser, MD
Phone
646-888-2118
Email
romessep@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Gomez, MD
Phone
212-639-2087
Email
gomezd@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Romesser, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Romeser, MD
Phone
646-888-2118
Facility Name
Memorial Sloan Kettering Monmouth (All Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Romesser, MD
Phone
646-888-2118
Facility Name
Memorial Sloan Kettering Bergen (All protocol activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Romesser, MD
Phone
646-888-2118
Facility Name
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Romesser, MD
Phone
646-888-2118
Facility Name
Memorial Sloan Kettering Westchester (All Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Romesser, MD
Phone
646-888-2118
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Romesser, MD
Phone
646-888-2118
Facility Name
Memorial Sloan Kettering Nassau (All protocol activities)
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Romesser, MD
Phone
646-888-2118

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)

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