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

Non-Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04384146
• Other study ID #: 20-148
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 7, 2020
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Radiation:
• 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.

Behavioral:
• EORTC QLQ-C30 questionnaire
at baseline, each cycle of Quad Shot, and at 3 weeks, 3 months and 6 months after last cycle of Quad Shot.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (All Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack (All protocol activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (All protocol activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (All Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (All protocol activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (All protocol activities)	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center