Thoracic Radiotherapy for Patients With Metastatic (Stage IV) Non-Small Cell Lung Cancer at High Risk of Symptomatic Progression Within the Thorax (DRO2301)

Phase II Trial of Thoracic Radiotherapy for Patients With Metastatic (Stage IV) Non-Small Cell Lung Cancer at High Risk of Symptomatic Progression Within the Thorax

Patients with metastatic non small cell lung cancer with high risk location or size are treated with prophylactic radiation therapy in conjunction with standard of care systemic therapy.

Study Overview

• Status: Recruiting
• Conditions: Radiotherapy; Stage 4 NSCLC
• Intervention / Treatment: Radiation: Prophylactic Palliative Radiotherapy

Detailed Description

This will be a single-cohort Phase II single center, prospective trial. Patients with stage IV NSCLC are eligible. Patients may receive standard of care systemic therapy (chemotherapy and/or immunotherapy). Radiotherapy will be directed at high-risk disease (primary cancer, nodal metastases, and metastases) in the thorax. Treatment of other sites of extrathoracic metastases would be allowed as per standard of care. Standard chest radiation dosing and normal tissue exposures (based on published or ongoing studies) will be applied. There is no plan to escalate the chest radiation dose (i.e., no Phase I component) as palliative regimens for NSCLC have been routinely used for many decades.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Therese Smudzin; Phone Number: 585-275-7848; Email: Therese_Smudzin@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester
      • Contact: Therese Smudzin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pathologic diagnosis of Non-Small Cell Lung Cancer (NSCLC) without targetable/oncogene driven mutations (i.e., EGFR mutations, ALK-rearrangement, ROS1 rearrangement).
• T1-4(or Tx)N0-3M1a-c, Stage IV disease (using the 8th edition of the AJCC staging manual) or metastatic recurrence of primary Stage I-III NSCLC that had been treated with curative intent therapy, without prior thoracic radiotherapy.
• Thoracic lung and/or nodal lesion(s) amenable to palliative chest radiotherapy.
• All subjects are required to have one or more of the following high-risk features: a) a non-central primary lung lesion ≥5 cm in size (at least T3 by criteria); b) bulky (≥2 cm) parenchymal lung lesions and/or nodal lesions abutting (within 1 cm) any of the following: Proximal bronchial tree, Esophagus, Vertebra, Heart, brachial plexus or subclavian vessels (if brachial plexus not well visualized), Superior vena cava
• Prior systemic therapy is allowed. Subjects must be enrolled within 6 months of first cycle of systemic therapy for Stage IV disease.
• Systemic therapy following the thoracic radiotherapy (on protocol) is allowed.
• Prior palliative surgical treatment (including airway debridement) is allowed.
• Concurrent chemotherapy (chemotherapy delivered from ≤2 days of before through ≤2 days after radiotherapy) is NOT allowed.
• Concurrent immunotherapy therapy is allowed.
• Subjects may undergo (or may have undergone) standard extrathoracic radiotherapy off protocol, including (but not limited to): Palliation of symptomatic bone metastases, prophylactic palliation of high-risk bone metastases, cranial radiosurgery (with controlled intracranial metastases if performed prior to enrollment), Ablative or non-ablative definitive radiotherapy for oligometastases.
• Subjects may undergo concurrent palliative thoracic radiotherapy (per study) and palliative radiotherapy for thoracic bone metastases (i.e., painful spine or rib metastases). It is anticipated that the study will be open at multiple sites within the Wilmot Cancer Institute network. Among these sites, subjects may be consulted and consented at any site, simulated and planned at any site, and treated at any site (even if different from the site(s) at which the subject was consulted and simulated).

Exclusion Criteria:

• Prior radiation therapy to the thoracic region.
• Active systemic lupus or Sjogren's disease.
• NSCLC (primary, nodal sites or metastases) causing severe symptoms requiring thoracic palliative radiotherapy for indications other than bone pain. These symptoms include superior vena cava syndrome, active and large volume (>100 ml per day) hemoptysis, airway obstruction (stridor, post-obstructive pneumonia, progressive dyspnea not attributed to other causes), compression of the spinal cord or spinal nerve roots, vertebral compression fracture, brachial plexopathy (from compression).
• Baseline ECOG performance status of 3-4. For the purposes of eligibility, Karnofsky Performance Score (KPS) will be converted to ECOG/Zubrod performance score, per ECOG guidelines.
• Brain metastases not amenable to immunotherapy alone, resection or stereotactic radiosurgery (i.e., brain metastases requiring whole brain radiotherapy).
• Malignant pleural effusion attributable to grossly apparent pleural disease. Subjects with malignant pleural effusion amenable to therapeutic thoracenteses and without radiographic evidence of pleural disease (i.e., studding or masses) are potentially eligible.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prophylactic Palliative Radiotherapy	Radiation: Prophylactic Palliative Radiotherapy; Prophylactic Palliative Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from symptomatic progression of irradiated thoracic target(s)	Kaplan-Meier freedom from symptomatic progression of irradiated thoracic target(s) at 6 months, 1 year, and 2 years.	6 month, 1 year, and 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS (Kaplan-Meier) (Kaplan-Meier)	Kaplan Meier Overall Survival	6 month, 1 year, and 2 years
Freedom from local recurrence of irradiated thoracic target lesion(s)	Freedom from local recurrence of irradiated thoracic target lesion(s)	6 month, 1 year, and 2 years
PFS (freedom from local and distant progression; Kaplan-Meier)	Progression (local or distant) free survival Outcome	6 month, 1 year, and 2 years
Duration of time that patient is maintenance	Duration of time that patient remains on maintenance systemic therapy	6 month, 1 year, and 2 years

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: URLUN23099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No