Phase 3 Lung Cancer Trial, Recruiting NCT06452277 Sponsor: Bayer Condition: Lung Cancer
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Phase 3 Lung Cancer Trial, Recruiting

NCT06452277
Recruiting Phase 3 🇦🇺 Australian site

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:

  • 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.

Contact this trial

Phone: (+)1-888-84 22937

Australian sites

NSW Health - Blacktown Hospital, Blacktown, New South Wales
Concord Repatriation General Hospital - Medical Oncology Clinical Trials Unit, Concord, New South Wales
Calvary Mater Hospital Newcastle - Oncology, Waratah, New South Wales
University of the Sunshine Coast, Buderim, Queensland
Toowoomba Hospital Oncology Clinical Trials, Toowoomba, Queensland
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.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
28 August 2024
Est. completion
28 October 2027

Where this trial is recruiting

🇦🇷 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.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

View original record on ClinicalTrials.gov