Phase 3 study for people with Lung Cancer

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor University of Sydney
Registry number NCT06127654
Started 1 January 2026 Today 16 October 2026 Estimated completion 1 December 2028

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
SWSLHD - Liverpool, Campbelltown and Bankstown-Lidcombe Hospitals Liverpool NSW Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 165

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria

1. Aged 18 years or older.

2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

3. Histologically proven non-small cell lung cancer.

4. Stage 3 as determined using the IASLC (International Association for the Study of Lung Cancer) 8th edition lung cancer staging guidelines.

5. To be treated with curative intent external beam radiotherapy (60 Gy in 30 treatments or 55 Gy in 20 treatments) +/- concurrent chemotherapy and adjuvant PD1/PD-L1 inhibitors.

6. Whole body Positron Emission Tomography (PET) scan within 8 weeks of registration.

7. Pulmonary function tests within 8 weeks of registration.

8. Willingness to give written informed consent.

9. Willingness to comply with the study procedures and visit requirements.

10. Available for follow up for a minimum of 12 months and up to 3 years.

Post-inclusion criteria includes the results of a Quality of Life (QoL) assessment and treatment plan assessment, neither of which are known prior to consent. The post-inclusion criteria for the VITaL trial are:

1. Functional Assessment of Cancer Therapy - Lung (FACT-L) Trial Outcome Index (TOI) score of ≥5, the clinically meaningful difference

2. The standard treatment plan shows that at least 16% of volume of the lungs (minus the Gross Tumour Volume (GTV)) will receive more than 20 Gy. This criterion is based on the difference in pneumonitis risk between patients receiving below (\~8%) and above (\~34%) this threshold.

The QoL assessment is unlikely to eliminate any patients but is included for patients where no clinically meaningful difference will be possible. The treatment plan assessment may exclude 20% of otherwise eligible patients.

Exclusion Criteria:

1. Serious medical comorbidities that may contraindicate curative radiotherapy.

2. Inability to attend full course of radiotherapy or follow-up visits.

3. A current or former diagnosis of interstitial lung disease.

4. Prior history of lung cancer within 5 years.

5. Prior thoracic radiotherapy at any time.

6. Prior surgery for this cancer within a year.

7. Prior chemotherapy for this cancer.

8. Pregnant or lactating women.

Dates on the record

Started 1 January 2026
Estimated completion 1 December 2028
Registry last updated 19 May 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 19 May 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.