Non-Small Cell Lung CancerPhase 1NCT04384146
Radiation Therapy to Relieve Symptoms in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 study testing Cyclical Hypofractionated Palliative Radiation (Quad Shot) and EORTC QLQ-C30 questionnaire in people with Non-Small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. 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?
- Cyclical Hypofractionated Palliative Radiation (Quad Shot) and EORTC QLQ-C30 questionnaire
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 7 sitesUnited States
- Study dates
- 7 May 2020to 5 Feb 2026
- 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
- 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)
Show all 24Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (All protocol activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, 11553
About this study
Official title: 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Cyclical Hypofractionated Palliative Radiation (Quad Shot), EORTC QLQ-C30 questionnaire
- Keywords
- Cyclical Hypofractionated Palliative Radiation (Quad Shot, 20-148
- 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.
Cyclical Hypofractionated Palliative Radiation (Quad Shot)Radiation
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.
EORTC QLQ-C30 questionnaireBehavioural
at baseline, each cycle of Quad Shot, and at 3 weeks, 3 months and 6 months after last cycle of Quad Shot.
| Study group | Role | What they receive |
|---|---|---|
| Quad Shot Radiation | Experimental | 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. Receives: Radiation: Cyclical Hypofractionated Palliative Radiation (Quad Shot); Behavioral: EORTC QLQ-C30 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
Number of participants who are able to complete the assigned radiation therapy regimen (3 cycles of quad shot)
To assess the feasibility of delivering up to 3 cycles of quad shot palliative radiation therapy to Stage IV NSCLC patients.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start7 May 2020
- Primary completion5 Feb 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I, prospective trial.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Ma, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384146
- Sponsor's protocol ID
- 20-148
- Status last verified
- Feb 2026
- First submitted
- 8 May 2020
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04384146
- Acronym / sponsor ID
- 20-148
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Cyclical Hypofractionated Palliative Radiation (Quad Shot, 20-148
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 7 May 2020 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I, prospective trial.
| Arm | Type | Receives |
|---|---|---|
| Quad Shot Radiation | Experimental | Radiation: Cyclical Hypofractionated Palliative Radiation (Quad Shot), Behavioral: EORTC QLQ-C30 questionnaireIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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:
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Quad Shot Radiation |
| EORTC QLQ-C30 questionnaireat baseline, each cycle of Quad Shot, and at 3 weeks, 3 months and 6 months after last cycle of Quad Shot. | Behavioural | Quad Shot Radiation |
Primary outcome
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
1 secondary outcome
Number of participants who are able to complete the assigned radiation therapy regimen (3 cycles of quad shot)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Ma, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclical Hypofractionated Palliative Radiation (Quad Shot) and EORTC QLQ-C30 questionnaire in people with Non-Small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 7 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 24 inclusion and 3 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 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Dose Limiting Toxicity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2026.