Radiation Therapy to Relieve Symptoms in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

March 25, 2024 updated by: Memorial Sloan Kettering Cancer Center

PROMISE 006: A Phase I Study of up to 3 Cycles of Cyclical Hypofractionated Palliative Radiation (Quad Shot) for Lung Tumors in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

This study will test the safety of Quad Shot radiation therapy using 2 different treatment schedules to find out what effects, if any, this treatment has on people with advanced NSCLC who are receiving systemic therapy for their cancer. The Quad Shot treatment schedule reduces the number of days needed to deliver the radiation treatments, which may be less disruptive to systemic therapy schedules.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Afsheen Iqbal, MD
  • Phone Number: 908-542-3383

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
        • Contact:
          • Annemarie Shepherd, MD
          • Phone Number: 908-542-3430
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (All Protocol Activities)
        • Contact:
          • Annemarie Shepherd, MD
          • Phone Number: 908-542-3430
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (All Protocol Activities)
        • Contact:
          • Annemarie Shepherd, MD
          • Phone Number: 908-542-3430
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack (All protocol activities)
        • Contact:
          • Annemarie Shepherd, MD
          • Phone Number: 908-542-3430
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (All Protocol Activities)
        • Contact:
          • Annemarie Shepherd, MD
          • Phone Number: 908-542-3430
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Annemarie Shepherd, MD
          • Phone Number: 908-542-3430
      • Rockville Centre, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (All Protocol Activities)
        • Contact:
          • Annemarie Shepherd, MD
          • Phone Number: 908-542-3430

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed non-small cell lung cancer with metastatic disease detected on cross-sectional imaging with a plan for one of the following systemic therapies:

    • Carboplatin/paclitaxel
    • Carboplatin/paclitaxel/pembrolizumab
    • Carboplatin/pemetrexed
    • Carboplatin/pemetrexed/pembrolizumab
    • Pembrolizumab (single agent or in combination with other regimens in this list)
    • Cisplatin/pemetrexed
    • Cisplatin/pemetrexed/pembrolizumab
    • Pemetrexed/pembrolizumab
    • Pemetrexed
    • Nivolumab (single agent or in combination with other regimens in this list)
    • Ipilimumab/nivolumab
    • Carboplatin/etoposide
    • Carboplatin/etoposide/atezolizumab
    • Cisplatin/etoposide
    • Cisplatin/etoposide/atezolizumab
    • Durvalumab (single agent or in combination with other regimens in this list)
    • Atezolizumab (single agent or in combination with other regimens in this list)
  • Patients eligible for the systemic therapy regimens notes
  • Patients with Stage IV NSCLC who have symptomatic (defined by patient-reported cough, dyspnea, or hemoptysis) or near-symptomatic (determined radiographically to be threatening the airway, esophagus or vasculature) centrally located.
  • KPS ≥ 60
  • Age ≥ 18 years.
  • Able to provide informed consent.
  • Patients at reproductive potential must agree to practice an effective contraceptive method.

Exclusion Criteria:

  • Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
  • Serious medical co-morbidities precluding radiotherapy.
  • Pregnant or breast-feeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Quad Shot Radiation
In this trial, patients with centrally located lung tumors will be treated with up to 3 cycles of Quad Shot Radiation. Radiation treatment will be given within 1 week of administration of chemotherapy. Quad Shot radiation will involve: 3.7 Gy twice daily x 2 days for a total dose of 14.8 Gy per cycle. The next cycle will occur after a 21-28 day break. The first group of patients will be treated with 2 cycles of quad shot radiation, followed by a 3-month observation period post-RT to allow a complete evaluation of acute toxicity. The next group of patients will be treated with either 1 cycle or 3 cycles of quad shot radiation. The minimum accrual is 4 patients with an expected accrual of 16 patients. Twenty additional patients will be recruited to an expansion cohort.
Radiation: Cyclical Hypofractionated Palliative Radiation (Quad Shot)
3.7 Gy twice daily x 2 days for a total dose of 14.8 Gy per cycle. The next cycle will occur after a 21-28 day break.
Behavioral: EORTC QLQ-C30 questionnaire
at baseline, each cycle of Quad Shot, and at 3 weeks, 3 months and 6 months after last cycle of Quad Shot.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Limiting Toxicity
Time Frame: 3 months
Dose Limiting Toxicity will be defined by CTCAE v5 grade 3 or higher for Esophagitis, Pneumonitis, Bronchial, bronchopleural or tracheal fistula, Bronchopulmonary or mediastinal hemorrhage. Patients will be evaluable for AE/DLTs from the start of study therapy through the end of the 3-month observation period
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who are able to complete the assigned radiation therapy regimen (3 cycles of quad shot)
Time Frame: 1 year
To assess the feasibility of delivering up to 3 cycles of quad shot palliative radiation therapy to Stage IV NSCLC patients.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Annemarie Shepherd, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2020

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

May 8, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-148

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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