Phase 3 Lung Cancer Trial, RecruitingNCT06452277Sponsor: BayerCondition: Lung Cancer
Printed from Voxsanity (voxsanity.com.au) — NCT06452277 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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:
People who are 18 years of age or older (or above the legal age of consent in their country) at the time of signing the consent form.
People with a confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (a specific type of lung cancer) that has either spread to other parts of the body or is not suitable for definitive treatment (Stage III or IV).
People whose lung cancer tumour has a specific genetic change (called a HER2 mutation in the tyrosine kinase domain), confirmed by an approved laboratory test on tumour tissue.
People who have not previously received systemic (whole-body) treatment for advanced or metastatic disease, and have not previously been treated with therapies specifically targeting a HER2 mutation. People who received treatment before or after surgery may still be considered, provided that treatment finished at least 12 months before the start of the screening period.
People whose treating doctor determines they are medically suitable to receive a specific combination of chemotherapy (cisplatin or carboplatin with pemetrexed) plus a drug called pembrolizumab, in line with official prescribing guidelines.
Who may not be able to join:
People with a history of another cancer, unless they received potentially curative treatment with no sign of the cancer returning for at least 5 years. Exceptions apply for certain cancer types if curatively treated or under surveillance: early-stage cervical, breast, or skin cancers; certain superficial bladder cancers; limited-stage prostate cancer; or basal or squamous cell skin cancers.
People whose tumour has a different genetic change for which an approved targeted treatment already exists (other than the specific HER2 mutation this trial is studying).
People who cannot stop taking ongoing oral or injected corticosteroid (steroid) medicines. People using inhalers, bronchodilators, or occasional local steroid injections would not be excluded. People using low-dose steroids to manage a hormone deficiency (such as adrenal or pituitary insufficiency) may still be considered, provided the dose has been stable for more than 4 weeks before the planned trial start.
People who already have moderate or severe nerve damage (called peripheral neuropathy, graded 2 or higher) before joining the trial.
People who have had a severe allergic reaction to a type of medicine called a monoclonal antibody in the past.
People who received radiation therapy to any part of the body outside the brain within 21 days before the planned trial start, or who are still experiencing side effects from prior radiation 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 27 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.
Austin Hospital - Olivia Newton John Cancer Research Institute, Heidelberg, Victoria
The Canberra Hospital (TCH) - Canberra Region Cancer Centre (CRCC), Garran,
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: NCT06452277
Sponsor: Bayer
Phase: Phase 3
Status: Recruiting
Condition: Lung Cancer
Trial contact: (+)1-888-84 22937
More information: https://clinicaltrials.gov/study/NCT06452277
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:
People who are 18 years of age or older (or above the legal age of consent in their country) at the time of signing the consent form.
People with a confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (a specific type of lung cancer) that has either spread to other parts of the body or is not suitable for definitive treatment (Stage III or IV).
People whose lung cancer tumour has a specific genetic change (called a HER2 mutation in the tyrosine kinase domain), confirmed by an approved laboratory test on tumour tissue.
People who have not previously received systemic (whole-body) treatment for advanced or metastatic disease, and have not previously been treated with therapies specifically targeting a HER2 mutation. People who received treatment before or after surgery may still be considered, provided that treatment finished at least 12 months before the start of the screening period.
People whose treating doctor determines they are medically suitable to receive a specific combination of chemotherapy (cisplatin or carboplatin with pemetrexed) plus a drug called pembrolizumab, in line with official prescribing guidelines.
Who may not be able to join:
People with a history of another cancer, unless they received potentially curative treatment with no sign of the cancer returning for at least 5 years. Exceptions apply for certain cancer types if curatively treated or under surveillance: early-stage cervical, breast, or skin cancers; certain superficial bladder cancers; limited-stage prostate cancer; or basal or squamous cell skin cancers.
People whose tumour has a different genetic change for which an approved targeted treatment already exists (other than the specific HER2 mutation this trial is studying).
People who cannot stop taking ongoing oral or injected corticosteroid (steroid) medicines. People using inhalers, bronchodilators, or occasional local steroid injections would not be excluded. People using low-dose steroids to manage a hormone deficiency (such as adrenal or pituitary insufficiency) may still be considered, provided the dose has been stable for more than 4 weeks before the planned trial start.
People who already have moderate or severe nerve damage (called peripheral neuropathy, graded 2 or higher) before joining the trial.
People who have had a severe allergic reaction to a type of medicine called a monoclonal antibody in the past.
People who received radiation therapy to any part of the body outside the brain within 21 days before the planned trial start, or who are still experiencing side effects from prior radiation 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 27 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
🇦🇷 Argentina
🇦🇺 Australia
🇦🇹 Austria
🇧🇪 Belgium
🇧🇷 Brazil
🇧🇬 Bulgaria
🇨🇦 Canada
🇨🇳 China
🇨🇿 Czechia
🇩🇰 Denmark
🇫🇮 Finland
🇫🇷 France
🇩🇪 Germany
🇬🇷 Greece
Hong Kong
🇭🇺 Hungary
🇮🇱 Israel
🇮🇹 Italy
🇯🇵 Japan
🇲🇾 Malaysia
🇲🇽 Mexico
🇳🇱 Netherlands
🇵🇱 Poland
🇵🇹 Portugal
🇷🇴 Romania
🇸🇬 Singapore
🇸🇰 Slovakia
🇰🇷 South Korea
🇪🇸 Spain
🇸🇪 Sweden
🇨🇭 Switzerland
🇹🇼 Taiwan
Turkey (Türkiye)
🇺🇦 Ukraine
🇬🇧 United Kingdom
🇺🇸 United States
7 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Progression free survival (PFS) per RECIST 1.1 as assessed by BICR
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.
Data last synced from ClinicalTrials.gov: 27 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.