Clinical trial NCT04384146: Radiation Therapy to Relieve Symptoms in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Keywords: Cyclical Hypofractionated Palliative Radiation (Quad Shot
20-148
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase I, prospective trial.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dose Limiting Toxicity
timeFrame: 3 months
Secondary outcomes:
measure: Number of participants who are able to complete the assigned radiation therapy regimen (3 cycles of quad shot)
timeFrame: 1 year
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All protocol activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (All protocol activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All protocol activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (All protocol activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jennifer Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: