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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Radiation: Cyclical Hypofractionated Palliative Radiation (Quad Shot)
* Behavioral: EORTC QLQ-C30 questionnaire


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Phase I, prospective trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quad Shot Radiation<br>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)<br>* 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.<br>Behavioral: EORTC QLQ-C30 questionnaire<br>* at baseline, each cycle of Quad Shot, and at 3 weeks, 3 months and 6 months after last cycle of Quad Shot.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who are able to complete the assigned radiation therapy regimen (1, 2, or 3 cycles of quad shot) | Feasibility will be determined by the number of patients who are able to complete the assigned radiation therapy regimen (1, 2, or 3 cycles of quad shot) over the number of patients who start the assigned radiation therapy regimen. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cyclical Hypofractionated Palliative Radiation (Quad Shot, 20-148