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NCT07005102

NCT07005102
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You are generally healthy and active enough to carry out light activities, even if you cannot do heavy physical work (your doctor will assess this using a standard scale).
  • You are willing to provide a tumor tissue sample — either a recent one or one stored from a previous biopsy — so it can be tested for a specific protein called c-Met before you can be assigned to a treatment group.
  • You have at least one area of cancer in your body that can be measured on a scan and has not previously been treated with radiation.
  • Any side effects from past cancer treatments have mostly or fully gone away (hair loss and mild nerve-related symptoms are exceptions).
  • You do not have any major life-threatening conditions other than your cancer, and your doctor estimates you have a life expectancy of at least 3 months.
  • You have not previously been treated with a specific type of targeted drug called an EGFR tyrosine kinase inhibitor (TKI) for advanced or spread cancer — or, if you took one after surgery to prevent cancer returning, at least 10.5 years have passed since your last dose.
  • You have been formally diagnosed with a type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that has spread, and your cancer has a specific genetic change (called an EGFR mutation in Exon 19 or Exon 21), confirmed by an approved laboratory test.

Who may not be able to join:

  • You have a history of a lung condition called interstitial lung disease (ILD), or inflammation of the lungs (pneumonitis) that needed treatment with steroid medicines, or your scans currently show signs of these conditions.
  • You have a history of certain other lung conditions, including pulmonary fibrosis, organizing pneumonia, or drug-related lung inflammation (confirm with trial site).
  • Your cancer has spread to the membranes surrounding the brain or spinal cord, or you have spinal cord compression that has not been treated with surgery or radiation.
  • You have had another type of cancer in the past, unless it was fully treated at least 2 years ago with a low chance of coming back, was a successfully treated non-melanoma skin cancer, was a localised cervical carcinoma in situ, or was an early-stage breast cancer considered completely cured.

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.

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.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
AbbVie
Registry
clinicaltrials_gov
Start date
3 August 2025
Est. completion
1 December 2031

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇨🇳 China 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇵🇹 Portugal 🇸🇬 Singapore 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇸 United States

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

Primary endpoints

Stage 1: Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; Stage 2: Progression-free survival (PFS) based on BICR assessment per RECIST version 1.1.; Number of Participants with Adverse Events (AEs)

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov