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OpenTrials
Completed

NCT Number: NCT04384146

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cyclical Hypofractionated Palliative Radiation (Quad Shot)

Radiation

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.

EORTC QLQ-C30 Questionnaire

Behavioral

at baseline, each cycle of Quad Shot, and at 3 weeks, 3 months and 6 months after last cycle of Quad Shot.

Primary outcomes

  1. 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

  1. Number of participants who are able to complete the assigned radiation therapy regimen (3 cycles of quad shot)

    Time frame: 1 year

    To assess the feasibility of delivering up to 3 cycles of quad shot palliative radiation therapy to Stage IV NSCLC patients.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
May 12, 2020
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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