Back to Lung Cancer

NCT05388669

NCT05388669
Active, Not Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with advanced or spreading non-small cell lung cancer (a type of lung cancer) that has been confirmed by a lab test, and your cancer has a specific gene change (mutation) in a gene called EGFR — either an "Exon 19 deletion" or an "Exon 21 L858R mutation" — detected through an approved blood or tissue test.
  • Your cancer got worse during or after treatment with a drug called osimertinib (or a similar newer targeted drug) AND a chemotherapy regimen containing platinum, though these do not need to have been given in a specific order (confirm with trial site for details on the order and type of prior treatments).
  • You have at least one tumor that can be measured on a scan, according to standard medical guidelines.
  • You are in relatively good general health and able to carry out everyday activities, as rated by a standard medical scale called ECOG performance status 0 or 1 (confirm with trial site if unsure what this means for you).
  • Any side effects from your previous cancer treatments have mostly gone away or returned to a mild, stable level, with some specific exceptions allowed (such as mild hair loss, mild nerve-related symptoms, or a thyroid condition that is controlled with medication).

Who may not be able to join:

  • You have received more cancer treatments beyond one course of platinum-based chemotherapy and EGFR-targeting drugs (i.e., you have had additional types of cancer therapies).
  • You received radiation therapy for pain relief fewer than 7 days before joining the trial.
  • You have brain metastases (cancer that has spread to the brain) that are causing symptoms or getting worse.
  • You have cancer that has spread to the membranes surrounding the brain or spinal cord, or you have pressure on your spinal cord that has not been fully treated with surgery or radiation.
  • You are experiencing pain caused by your tumor that is not well controlled.
  • You have a history of a lung condition called interstitial lung disease, including a form caused by a previous drug treatment or by radiation therapy.

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
Active, Not Recruiting
Phase
Phase 3
Sponsor
Janssen Research & Development, LLC
Registry
clinicaltrials_gov
Start date
5 August 2022
Est. completion
3 January 2024

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇫🇷 France 🇩🇪 Germany 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇾 Malaysia 🇵🇱 Poland 🇵🇹 Portugal 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇹🇭 Thailand Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State; For EU and Any Applicable Region: Observed Serum Concentration (Ctrough) of Amivantamab; Area Under the Concentration (AUC) Time Curve of Amivantamab From Day 1 to Day 15 (AUC [Day 1-15]) of Cycle 2

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