Phase 3 Lung Cancer Trial, Recruiting NCT06357533 Sponsor: AstraZeneca Condition: Lung Cancer
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Phase 3 Lung Cancer Trial, Recruiting

NCT06357533
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 have been diagnosed with a specific type of lung cancer called non-squamous non-small cell lung cancer (NSCLC), confirmed by a laboratory test on a tissue or cell sample.
  • People whose lung cancer is at an advanced stage (Stage IIIB, IIIC, or Stage IV) and cannot be treated with surgery or a combination of chemotherapy and radiation aimed at curing the disease.
  • People whose tumour does not have certain specific genetic changes (called EGFR mutations, ALK rearrangements, or ROS1 rearrangements), and who do not have a confirmed local test result showing any other genetic change for which targeted first-line treatments are already approved and available locally.
  • People who are able to provide a tumour tissue sample so that certain markers on the tumour can be tested.
  • People whose tumour shows a high level of a protein called PD-L1, with at least 50% of tumour cells testing positive for it.
  • People who have at least one area of cancer in the body that has not previously been treated with radiation and can be measured according to standard guidelines.
  • People who are in good general health, able to carry out normal daily activities, with at most minor symptoms affecting daily life (rated 0 or 1 on a standard health scale called the ECOG scale).
  • People whose blood counts and organ function (such as liver and kidneys) are within acceptable levels.

Who may not be able to join:

  • People who have already received systemic drug treatment (such as chemotherapy or immunotherapy) for advanced or metastatic NSCLC.
  • People whose lung cancer is of the squamous cell type, mixed small cell type, or a rare form called sarcomatoid variant.
  • People who have been diagnosed with another type of cancer within the past three years.
  • People who have a history of, or currently have, certain immune system disorders or inflammatory conditions (some exceptions may apply — confirm with trial site).
  • People with severe or poorly controlled health conditions that could make trial participation unsafe or difficult to manage.
  • People with a significant build-up of fluid in body cavities (such as around the lungs) that cannot be drained repeatedly as needed.
  • People who have a history of lung inflammation (called ILD or pneumonitis), including from radiation or medication, or who show signs of possible lung inflammation on scans at the time of screening (some exceptions may apply — confirm with trial site).
  • People with significantly reduced lung function, as assessed by the treating doctor.
  • People with cancer that has spread to and is compressing the spinal cord, or cancer that has spread to the brain and is still causing symptoms, is not stable on scans, or still requires steroids or anti-seizure medication.
  • People who have had cancer spread to the membranes surrounding the brain and spinal cord (called leptomeningeal carcinomatosis).
  • People with significant corneal eye disease.
  • People with active tuberculosis, hepatitis B, hepatitis C, hepatitis A, or HIV that is not well managed.
  • People with a history of a primary immune deficiency condition.

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 15 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: Suresh S. Ramalingam, MD, Emory University, Atlanta, Georgia, United States of America.

Phone: 1-877-240-9479

Australian sites

Research Site, Birtinya,
Research Site, Blacktown,
Research Site, Clayton,
Research Site, Gosford,
Research Site, Melbourne,
Research Site, South Brisbane,
Research Site, Wodonga,

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
11 April 2024
Est. completion
28 December 2029

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇩🇪 Germany 🇭🇺 Hungary 🇮🇳 India 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland Puerto Rico 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇹🇭 Thailand Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States 🇻🇳 Vietnam

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

Primary endpoints

Progression-Free Survival (PFS) in TROP2 biomarker positive participants.; Overall Survival (OS) in TROP2 biomarker positive participants.

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: 15 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