Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial (NCT05388669) enrolled 418 people in total — 206 in one group who received a medicine called lazertinib together with amivantamab given as an injection under the skin (called SC-CF), and 212 in a second group who received lazertinib together with amivantamab given through a drip into a vein (called intravenous or IV). The trial was primarily measuring how much of the amivantamab medicine was present in participants' blood — specifically the amount remaining just before the next dose was due (called the "trough concentration") and the total amount of the drug in the blood over a set period of time. The reported data shows the following blood-level measurements for amivantamab. For the trough concentration measure used outside the European Union, the under-the-skin group had a reported value of 206 micrograms per millilitre, compared with 144 micrograms per millilitre in the drip group. For the trough concentration measure used in the European Union and certain other regions, the reported values were 335 micrograms per millilitre for the under-the-skin group and 293 micrograms per millilitre for the drip group. For the measure of total drug exposure in the blood over a 15-day window (called "area under the curve"), the reported figures were 135,861 and 131,704 micrograms-hour per millilitre for the under-the-skin and drip groups respectively. The reported data shows that three secondary outcomes — response rate (how many participants' disease responded), progression-free survival (how long before disease worsened), and duration of response (how long any response lasted) — were listed in the trial but no numerical results were submitted to ClinicalTrials.gov, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 38857463) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Lung Cancer Trial, Active, Not Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not 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 may be able to join
- 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
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- 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.
Trial contact details on record
Principal Investigator: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Australian sites
This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, including 6 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
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
Other options
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.