Stage 4 NSCLCPhase 2DRO2301NCT06262321
Thoracic Radiotherapy for Patients With Metastatic (Stage IV) Non-Small Cell Lung Cancer at High Risk of Symptomatic Progression Within the Thorax
A Phase 2 study testing Prophylactic Palliative Radiotherapy in people with Stage 4 NSCLC and Radiotherapy, run by University of Rochester at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage 4 NSCLC, Radiotherapy
- What is being tested?
- Prophylactic Palliative Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2024to 1 Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester
Rochester, New York, 14642
Therese Smudzin
About this study
Official title: 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.
Read the 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.
- Conditions
- Stage 4 NSCLC, Radiotherapy
- Being tested
- Prophylactic Palliative Radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic Palliative RadiotherapyRadiation
Prophylactic Palliative Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic Palliative Radiotherapy | Experimental | Prophylactic Palliative Radiotherapy Receives: Radiation: Prophylactic Palliative Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month, 1 year, and 2 years
Secondary outcomes (4)
OS (Kaplan-Meier) (Kaplan-Meier)
Kaplan Meier Overall Survival
Measured: 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)
Measured: 6 month, 1 year, and 2 years
PFS (freedom from local and distant progression; Kaplan-Meier)
Progression (local or distant) free survival Outcome
Measured: 6 month, 1 year, and 2 years
Duration of time that patient is maintenance
Duration of time that patient remains on maintenance systemic therapy
Measured: 6 month, 1 year, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start15 May 2024
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage 4 NSCLCStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Milano, MD,PhD, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262321
- Sponsor's protocol ID
- URLUN23099
- Acronym
- DRO2301
- Status last verified
- Aug 2025
- First submitted
- 7 Feb 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06262321
- Acronym / sponsor ID
- DRO2301 / URLUN23099
- Conditions
- Stage 4 NSCLC, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prophylactic Palliative Radiotherapy | Experimental | Radiation: Prophylactic Palliative RadiotherapyProphylactic Palliative Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylactic Palliative RadiotherapyProphylactic Palliative Radiotherapy | Radiation | Prophylactic Palliative Radiotherapy |
Primary outcome
Freedom from symptomatic progression of irradiated thoracic target(s)
Time frame: 6 month, 1 year, and 2 years
Kaplan-Meier freedom from symptomatic progression of irradiated thoracic target(s) at 6 months, 1 year, and 2 years.
4 secondary outcomes
OS (Kaplan-Meier) (Kaplan-Meier)
Time frame: 6 month, 1 year, and 2 years
Freedom from local recurrence of irradiated thoracic target lesion(s)
Time frame: 6 month, 1 year, and 2 years
PFS (freedom from local and distant progression; Kaplan-Meier)
Time frame: 6 month, 1 year, and 2 years
Duration of time that patient is maintenance
Time frame: 6 month, 1 year, and 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prophylactic Palliative Radiotherapy in people with Stage 4 NSCLC and Radiotherapy, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Therese Smudzin (585-275-7848, Therese_Smudzin@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from symptomatic progression of irradiated thoracic target(s) (time frame: 6 month, 1 year, and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.