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 Bristol-Myers Squibb
Registry number NCT07063745
Started 2 January 2026 Today 16 October 2026 Estimated completion 12 August 2031

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Local Institution - 0432 Liverpool NSW Not yet recruiting
GenesisCare St Leonards St Leonards NSW Recruiting
Sunshine Coast University Hospital Birtinya QLD Recruiting
Princess Alexandra Hospital Brisbane QLD Recruiting
Lyell McEwin Hospital Elizabeth Vale SA Recruiting
Royal Hobart Hospital Hobart TAS Recruiting
Grampians Health Ballarat Central VIC Recruiting
Local Institution - 0368 Garran ACT Not yet 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 590

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

* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.

* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.

* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

* Participants must have at least 1 measurable lesion as per RECIST v1.1.

Exclusion Criteria

* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.

* Participants must not have symptomatic brain metastases or spinal cord compression.

* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).

Note: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.

* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.

* Other protocol-defined Inclusion/Exclusion criteria apply.

Dates on the record

Started 2 January 2026
Estimated completion 12 August 2031
Registry last updated 23 September 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: 23 September 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.