Phase 3 Lung Cancer Trial, Recruiting (NCT04613596)

Phase 3 Lung Cancer Trial, Recruiting NCT04613596 Sponsor: Mirati Therapeutics Inc. Condition: Lung Cancer

Printed from Voxsanity (voxsanity.com.au) — NCT04613596 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Lung Cancer

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

(Phase 2) You have been diagnosed with non-small cell lung cancer (NSCLC) that cannot be removed by surgery or has spread to other parts of the body, confirmed by a tissue sample, and your cancer has a specific gene change called KRAS G12C.
(Phase 3) You have been diagnosed with a specific type of NSCLC (squamous or non-squamous) that cannot be removed by surgery or has spread, confirmed by a tissue sample, with the KRAS G12C gene change, and a protein marker called PD-L1 is found in 50% or more of your cancer cells.
(Phase 3) Your cancer can be measured on scans using standard medical guidelines.
(Phase 3) Based on a brain scan, you either have no signs of cancer in the brain, have cancer in the brain that has not been treated but does not need immediate treatment, or have previously treated brain cancer that does not need immediate further treatment.

Who may not be able to join:

(Phase 2 and Phase 3) You have already received any systemic treatment (such as chemotherapy, immunotherapy, or a drug targeting the KRAS G12C mutation) for advanced or spreading NSCLC.
(Phase 2) You currently have active cancer in the brain.
(Phase 3) You have known cancer in the brain or nervous system AND any one of the following applies: there is an untreated brain lesion larger than 2 cm; there is a lesion on the brainstem; you are taking steroid medications (such as prednisone) at a daily dose above 10 mg to manage brain-related symptoms; or you have poorly controlled seizures (more than once a week) or worsening neurological symptoms despite treatment (confirm with trial site).
(Phase 3) You have had high-dose radiation (more than 30 Gy) to the lungs within the 6 months before starting the study treatment.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 28 July 2026

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Bristol-Myers Squibb, Bristol-Myers Squibb

Phone: 855-907-3286

Australian sites

Ballarat Regional Integrated Cancer Center, Ballarat,
61(03)53208500

Flinders Medical Centre, Bedford Park,
61882048997

Local Institution - 007-004, Clayton,

Canberra Hospital, Garran,
610251242220

Icon Cancer Centre, Hyde Park,
+61742266514

Port Macquarie Base Hospital, Port Macquarie,
61265801820

Cancer Care Wollongong, Wollongong,
61242286200

Princess Alexandra Hospital, Woolloongabba,
0731766505

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · 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: NCT04613596

Sponsor: Mirati Therapeutics Inc.

Phase: Phase 3

Status: Recruiting

Condition: Lung Cancer

Trial contact: 855-907-3286

More information: https://clinicaltrials.gov/study/NCT04613596

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

(Phase 2) You have been diagnosed with non-small cell lung cancer (NSCLC) that cannot be removed by surgery or has spread to other parts of the body, confirmed by a tissue sample, and your cancer has a specific gene change called KRAS G12C.
(Phase 3) You have been diagnosed with a specific type of NSCLC (squamous or non-squamous) that cannot be removed by surgery or has spread, confirmed by a tissue sample, with the KRAS G12C gene change, and a protein marker called PD-L1 is found in 50% or more of your cancer cells.
(Phase 3) Your cancer can be measured on scans using standard medical guidelines.
(Phase 3) Based on a brain scan, you either have no signs of cancer in the brain, have cancer in the brain that has not been treated but does not need immediate treatment, or have previously treated brain cancer that does not need immediate further treatment.

Who may not be able to join:

(Phase 2 and Phase 3) You have already received any systemic treatment (such as chemotherapy, immunotherapy, or a drug targeting the KRAS G12C mutation) for advanced or spreading NSCLC.
(Phase 2) You currently have active cancer in the brain.
(Phase 3) You have known cancer in the brain or nervous system AND any one of the following applies: there is an untreated brain lesion larger than 2 cm; there is a lesion on the brainstem; you are taking steroid medications (such as prednisone) at a daily dose above 10 mg to manage brain-related symptoms; or you have poorly controlled seizures (more than once a week) or worsening neurological symptoms despite treatment (confirm with trial site).
(Phase 3) You have had high-dose radiation (more than 30 Gy) to the lungs within the 6 months before starting the study treatment.

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: 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 doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 3

Sponsor

Mirati Therapeutics Inc.

Registry

ClinicalTrials.gov

Start date

2 December 2020

Est. completion

31 October 2028

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇨🇴 Colombia 🇭🇷 Croatia 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇮 Finland 🇫🇷 France 🇬🇪 Georgia 🇩🇪 Germany 🇬🇷 Greece Hong Kong 🇭🇺 Hungary 🇮🇳 India 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇾 Malaysia 🇲🇽 Mexico 🇳🇱 Netherlands 🇳🇿 New Zealand 🇳🇴 Norway 🇵🇪 Peru 🇵🇭 Philippines 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇷🇸 Serbia 🇸🇬 Singapore 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇹🇼 Taiwan 🇹🇭 Thailand Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

8 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Phase 2: To evaluate the efficacy of Adagrasib monotherapy and in combination with pembrolizumab administered to patients having advanced/metastatic NSCLC.; Phase 3: To compare efficacy of Adagrasib in combination with pembrolizumab versus pembrolizumab

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov