Phase 3 study for people with Lung Cancer

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 15 October 2026 Not medical advice

This trial at a glance

Status Recruiting

Phase Phase 3

Sponsor Amgen

Registry number NCT05920356

Started 16 November 2023 Today 16 October 2026 Estimated completion 30 June 2027

Where this trial is running

Trial sites and the status recorded for each
Site	City	State or country	Status at this site
Campbelltown Hospital	Campbelltown	NSW	Recruiting
Concord Repatriation General Hospital	Concord	NSW	Recruiting
Nepean Cancer Centre	Kingswood	NSW	Recruiting
Port Macquarie Base Hospital	Port Macquarie	NSW	Recruiting
GenesisCare -North Shore Oncology	St Leonards	NSW	Completed
Calvary Mater Newcastle Hospital	Waratah	NSW	Terminated
Toowoomba Hospital	Toowoomba	QLD	Recruiting
Princess Alexandra Hospital	Woolloongabba	QLD	Completed
Cancer Research South Australia	Adelaide	SA	Recruiting
Peter MacCallum Cancer Centre	Melbourne	VIC	Recruiting
The Alfred Hospital	Melbourne	VIC	Completed

voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice

Who can join

Age 18 Years to 100 Years

Sex Anyone, regardless of sex

Healthy volunteers Not accepted

Enrolment target 750

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:

* Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing

* No history of systemic anticancer therapy in metastatic/non-curable settings

* Eastern Cooperative Oncology Group (ECOG) ≤ 1

Exclusion Criteria:

* Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology

* Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy

* Symptomatic (treated or untreated) brain metastases

* Gastrointestinal (GI) tract disease causing the inability to take oral medication

* Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina

* Prior therapy with a KRAS G12C inhibitor

Dates on the record

Started 16 November 2023

Estimated completion 30 June 2027

Registry last updated 13 October 2026

Checked by Voxsanity 15 October 2026

Results, publications and the official record

No results are posted on the official record yet.
No publications are listed on the official record yet.
Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.

Sources and dates

ClinicalTrials.gov – the record this page reformats
ClinicalTrials.gov processing date: 13 October 2026.
This page last checked by Voxsanity: 15 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.

Voxsanity

Clinical trials recruiting in Australia, from the public registries · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial, which may be relevant to my care:

Trial: NCT05920356

Sponsor: Amgen

Phase: Phase 3

Status: Recruiting

Condition: Lung Cancer

More information: https://clinicaltrials.gov/study/NCT05920356

Eligibility criteria, as the registry published them

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing
No history of systemic anticancer therapy in metastatic/non-curable settings
Eastern Cooperative Oncology Group (ECOG) ≤ 1

Exclusion Criteria:

Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy
Symptomatic (treated or untreated) brain metastases
Gastrointestinal (GI) tract disease causing the inability to take oral medication
Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina
Prior therapy with a KRAS G12C inhibitor

A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a registered health practitioner to access unapproved therapeutic goods for individual patients.

Not medical advice. Voxsanity reformats information published by public registries. It does not give medical advice and is not a substitute for talking to your doctor.