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)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 41
- Locations
- 7
- Primary Endpoint
- Dose Limiting Toxicity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
Arms & Interventions
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.
Intervention: Cyclical Hypofractionated Palliative Radiation (Quad Shot) (Radiation)
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.
Intervention: EORTC QLQ-C30 questionnaire (Behavioral)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Number of participants who are able to complete the assigned radiation therapy regimen (3 cycles of quad shot)(1 year)