Radiation Therapy to Relieve Symptoms in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
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)
1 other identifier
interventional
41
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 nonsmall-cell-lung-cancer
Started May 2020
Longer than P75 for phase_1 nonsmall-cell-lung-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 7, 2020
CompletedFirst Submitted
Initial submission to the registry
May 8, 2020
CompletedFirst Posted
Study publicly available on registry
May 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2026
CompletedFebruary 9, 2026
February 1, 2026
5.8 years
May 8, 2020
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose Limiting Toxicity
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 Outcomes (1)
Number of participants who are able to complete the assigned radiation therapy regimen (3 cycles of quad shot)
1 year
Study Arms (1)
Quad Shot Radiation
EXPERIMENTALIn 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.
Interventions
at baseline, each cycle of Quad Shot, and at 3 weeks, 3 months and 6 months after last cycle of 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.
Eligibility Criteria
You may qualify if:
- 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
- +9 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack (All protocol activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Ma, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2020
First Posted
May 12, 2020
Study Start
May 7, 2020
Primary Completion
February 5, 2026
Study Completion
February 5, 2026
Last Updated
February 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
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.