Stage III Non-small Cell Lung CancerARTIA-LungNCT05488626

Daily Adaptive Radiation Therapy: An Individualized Approach for Stage III Lung Cancer

A study testing Adaptive Radiotherapy, Non-Adaptive Radiotherapy and Chemotherapy in people with Stage III Non-small Cell Lung Cancer, run by Varian, a Siemens Healthineers Company at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Stage III Non-small Cell Lung Cancer
What is being tested?: Adaptive Radiotherapy, Non-Adaptive Radiotherapy and Chemotherapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 20 Oct 2022to Dec 2028
Phase: Interventional
Are there results?: None posted in the registry

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

Provision of signed and dated informed consent form.
Histologically confirmed NSCLC
Clinical stage IIIA-IIIB (AJCC v8) disease who are either:
Patients classified as non-operable by the treatment team
Patients who refuse surgery
Clinical stage IIIC due to contralateral mediastinal lymph node involvement only (e.g., no contralateral hilar or any supraclavicular/cervical lymph node metastases). Mediastinal stations 2R and 4R are considered contralateral for patients whose primary tumor is within the left lung. Mediastinal stations 2L, 4L, 5, and 6 are considered contralateral for patients whose primary tumor is in the right lung.

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Completed evaluation for metastatic disease with no distant metastases identified. Evaluation must include the following:
History and physical examination within 30 days prior to enrollment.
Whole body FDG PET-CT for staging within 60 days prior to enrollment
Brain MRI or contrast enhanced CT within 60 days prior to enrollment.
ECOG performance status 0-2 and deemed clinically fit for chemoradiotherapy.
Age ≥18 years (or at least the local age of consent)
Patients must have normal organ and marrow function.
Serum creatinine ≤1.5 mg/dL within 60 days prior to enrollment.
Measurable disease must be present.
Negative urine or serum pregnancy test within 14 days prior to enrollment for women of childbearing potential.

Who cannot join

Contralateral hilar or any supraclavicular/cervical lymph nodes.
Baseline grade ≥3 dyspnea, or cough, or dysphagia.
Prior invasive non-skin malignancy unless disease free for a minimum of 3 years.
History of prior RT to the thorax.
Severe imaging artifact that, in the view of the local investigator, would preclude accurate identification of the thoracic anatomy and tumor targets on the cone beam CT (e.g., artifact created implanted cardiac device in proximity to the targets).
Evidence of malignant pleural effusion, defined as either FDG PET avidity within effusion fluid or presence of malignant cells identified by cytology of thoracentesis fluid.

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Severe active chronic obstructive pulmonary disease or respiratory illness other than NSCLC precluding study therapy.
Hospitalization for chronic obstructive pulmonary disease or respiratory illness other than NSCLC within 1 year prior to study enrollment.
Women of childbearing potential and sexually active women not willing or able to use contraception.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Alabama at Birmingham
Birmingham, Alabama, 35294

Other trials in United States

About this study

Official title: Daily Adaptive vs Non-Adaptive External Beam Radiation Therapy With Concurrent Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Prospective Randomized Trial of an Individualized Approach for Toxicity Reduction (ARTIA-Lung)

This is a prospective multi-center randomized clinical trial designed to demonstrate that daily online adaptive radiotherapy with concomitant chemotherapy for stage III non-small cell lung cancer (NSCLC) will result in decreased acute respiratory and esophageal toxicity compared with non-adaptive radiotherapy with concomitant chemotherapy. The timepoint for this assessment will be 3 months following the end of radiotherapy and will use the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

Conditions: Stage III Non-small Cell Lung Cancer
Being tested: Adaptive Radiotherapy, Non-Adaptive Radiotherapy, Chemotherapy, Immunotherapy
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.

Adaptive RadiotherapyDevice
Standard fractionation external beam radiotherapy (60-66 Gy in 2 Gy/fraction) with daily online adaptation.
Non-Adaptive RadiotherapyDevice
Standard fractionation external beam radiotherapy (60-66 Gy in 2 Gy/fraction) with daily image guidance.
ChemotherapyDrug
Concomitant chemotherapy per NCCN or other national guidelines.
ImmunotherapyDrug
Adjuvant immunotherapy per national or institutional guidelines.

Study groups in NCT05488626
Study group	Role	What they receive
Adaptive Arm	Experimental	Subjects in this arm will receive their external beam radiotherapy on the Ethos Radiotherapy System version 2.0 with HyperSight cone beam computed tomography imaging, with daily online adaptation of their radiation dosimetry plan to account for day-to-day changes in the tumor and surrounding anatomical structures. All subjects will received standard concurrent chemotherapy and may receive adjuvant immunotherapy, if indicated. Receives: Device: Adaptive Radiotherapy; Drug: Chemotherapy; Drug: Immunotherapy
Non-Adaptive Arm	Active comparator	Subjects in this arm will receive their radiotherapy using standard image-guided radiation therapy (IMRT) techniques. All subjects will receive standard concurrent chemotherapy and may receive adjuvant immunotherapy, if indicated. Receives: Device: Non-Adaptive Radiotherapy; Drug: Chemotherapy; Drug: Immunotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Acute toxicity
Composite rate of any increase in cough, or dyspnea, or dysphagia scores by 1+ using PRO-CTCAE.
Measured: From randomization to 90 days after completion of chemoradiotherapy

Secondary outcomes (8)

Lung cancer specific quality of life
Results from the FACT-L questionnaire
Measured: From randomization to 12 months after completion of chemoradiotherapy
Global quality of life
Results from the EQ-5D-5L questionnaire
Measured: From randomization to 12 months after completion of chemoradiotherapy
Normal lung tissue radiation exposure
The percentage of normal lung tissue volume that receives radiation of 20 Gy or more over the course of radiation treatment.
Measured: End of external beam radiation treatment (approximately 2 months from randomization)
Mean normal tissue doses
Mean dose delivered to the heart, esophagus and normal lung tissue over the course of radiation treatment.
Measured: End of external beam radiation treatment (approximately 2 months from randomization)
Overall response rate
Frequency of complete and partial tumor response as determined on chest imaging using RECIST v1.1
Measured: 3 months, 6 months and 12 months after completion of chemoradiotherapy
Local progression
Physician report of progression determined by imaging or clinical evaluation
Measured: 12 months after completion of chemoradiotherapy
Radiation pneumonitis
CTCAE v.5.0 grade 2+ pneumonitis
Measured: 12 months after completion of chemoradiotherapy
Healthcare resource utilization
Hospitalizations, emergency department visits, advanced medical or imaging procedures associated with the treatment of CTCAE grade 2+ adverse events related to EBRT.
Measured: From the start of radiation treatment to 12 months after completion of chemoradiotherapy.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 2022Dec 2028

First posted4 Aug 2022
Study start20 Oct 2022
Primary completionDec 2027 (estimated)
Study completionDec 2028 (estimated)

Why it stopped: Shifting patterns of care for the target population.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stage III Non-small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Varian, a Siemens Healthineers CompanyThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05488626
Sponsor's protocol ID: VAR-2021-09
Acronym: ARTIA-Lung
Status last verified: Feb 2026
First submitted: 3 Aug 2022
Last updated: 5 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Daily Adaptive vs Non-Adaptive External Beam Radiation Therapy With Concurrent Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Prospective Randomized Trial of an Individualized Approach for Toxicity Reduction (ARTIA-Lung)
ClinicalTrials.gov ID: NCT05488626
Acronym / sponsor ID: ARTIA-Lung / VAR-2021-09
Conditions: Stage III Non-small Cell Lung Cancer
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Shifting patterns of care for the target population.
Enrolment: 0 participants (actual)
Lead sponsor: Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
Study start: 20 Oct 2022 (actual)
Primary completion: Dec 2027 (estimated)
Study completion: Dec 2028 (estimated)
First posted: 4 Aug 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Adaptive Arm	Experimental	Device: Adaptive Radiotherapy, Drug: Chemotherapy, Drug: ImmunotherapySubjects in this arm will receive their external beam radiotherapy on the Ethos Radiotherapy System version 2.0 with HyperSight cone beam computed tomography imaging, with daily online adaptation of their radiation dosimetry plan to account for day-to-day changes in the tumor and surrounding anatomical structures. All subjects will received standard concurrent chemotherapy and may receive adjuvant immunotherapy, if indicated.
Non-Adaptive Arm	Active comparator	Device: Non-Adaptive Radiotherapy, Drug: Chemotherapy, Drug: ImmunotherapySubjects in this arm will receive their radiotherapy using standard image-guided radiation therapy (IMRT) techniques. All subjects will receive standard concurrent chemotherapy and may receive adjuvant immunotherapy, if indicated.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Provision of signed and dated informed consent form.
Histologically confirmed NSCLC
Clinical stage IIIA-IIIB (AJCC v8) disease who are either:
Clinical stage IIIC due to contralateral mediastinal lymph node involvement only (e.g., no contralateral hilar or any supraclavicular/cervical lymph node metastases). Mediastinal stations 2R and 4R are considered contralateral for patients whose primary tumor is within the left lung. Mediastinal stations 2L, 4L, 5, and 6 are considered contralateral for patients whose primary tumor is in the right lung.
Completed evaluation for metastatic disease with no distant metastases identified. Evaluation must include the following:

Key exclusion criteria (9 listed)

Contralateral hilar or any supraclavicular/cervical lymph nodes.
Baseline grade ≥3 dyspnea, or cough, or dysphagia.
Prior invasive non-skin malignancy unless disease free for a minimum of 3 years.
History of prior RT to the thorax.
Severe imaging artifact that, in the view of the local investigator, would preclude accurate identification of the thoracic anatomy and tumor targets on the cone beam CT (e.g., artifact created implanted cardiac device in proximity to the targets).

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
Adaptive RadiotherapyStandard fractionation external beam radiotherapy (60-66 Gy in 2 Gy/fraction) with daily online adaptation.	Device	Adaptive Arm
Non-Adaptive RadiotherapyStandard fractionation external beam radiotherapy (60-66 Gy in 2 Gy/fraction) with daily image guidance.	Device	Non-Adaptive Arm
ChemotherapyConcomitant chemotherapy per NCCN or other national guidelines.	Drug	Adaptive Arm, Non-Adaptive Arm
ImmunotherapyAdjuvant immunotherapy per national or institutional guidelines.	Drug	Adaptive Arm, Non-Adaptive Arm

Primary outcome

Acute toxicity
Time frame: From randomization to 90 days after completion of chemoradiotherapy
Composite rate of any increase in cough, or dyspnea, or dysphagia scores by 1+ using PRO-CTCAE.

8 secondary outcomes

Lung cancer specific quality of life
Time frame: From randomization to 12 months after completion of chemoradiotherapy
Global quality of life
Time frame: From randomization to 12 months after completion of chemoradiotherapy
Normal lung tissue radiation exposure
Time frame: End of external beam radiation treatment (approximately 2 months from randomization)
Mean normal tissue doses
Time frame: End of external beam radiation treatment (approximately 2 months from randomization)
Overall response rate
Time frame: 3 months, 6 months and 12 months after completion of chemoradiotherapy
Local progression
Time frame: 12 months after completion of chemoradiotherapy
Radiation pneumonitis
Time frame: 12 months after completion of chemoradiotherapy
Healthcare resource utilization
Time frame: From the start of radiation treatment to 12 months after completion of chemoradiotherapy.

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Andrew McDonald, MD principal investigator

University of Alabama at Birmingham

Dennis Stanley, PhD principal investigator

University of Alabama at Birmingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 inclusion and 9 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: withdrawn, as of the sponsor's last update on 5 Feb 2026. 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.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute toxicity (time frame: From randomization to 90 days after completion of chemoradiotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05488626.

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 5 Feb 2026.