Status:
ACTIVE_NOT_RECRUITING
Radiation Therapy to Relieve Symptoms in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 receivin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04384146
Start Date
May 7 2020
End Date
May 1 2026
Last Update
June 3 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Commack (All protocol activities)
Commack, New York, United States, 11725