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Phase 4 Lung Cancer Trial, Not Yet Recruiting
NCT07469488
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
- People who are at least 18 years old (or the legal age of consent in the country where the study is taking place) at the time of signing the consent form.
- People who have a confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer (a type of lung cancer) with a specific genetic change called an EGFR mutation, at Stage IIIB, IIIC, or IV.
- People who have signed a consent form (along with a legal representative if applicable) showing they understand the study's purpose, what it involves, and that they are willing to take part.
- People whose general physical health and ability to carry out daily activities meets a specific standard, rated 0 or 1 on a medical scale (meaning fully active or restricted in strenuous activity but able to do light work) (confirm with trial site).
- People who have brain metastases (cancer that has spread to the brain) that either cause no symptoms, or have already been treated and are stable, with no steroid use and a stable condition for at least 2 weeks before starting the study treatment.
- People who are willing to follow a specific skin care management plan and take preventive medication to reduce the risk of infusion reactions during treatment with amivantamab and lazertinib, or amivantamab with chemotherapy.
- Cohort 1 – First-line treatment for a specific EGFR mutation: People whose EGFR mutation is specifically an Ex19del or Ex21 L858R type, whose doctor has determined that amivantamab (given by infusion) and lazertinib is the appropriate treatment, who have not previously received treatment for their advanced or metastatic lung cancer, and whose cancer cannot be treated with the aim of a cure through surgery or radiation (prior adjuvant or neoadjuvant therapy is permitted if the last dose was given more than 12 months before the cancer became locally advanced or metastatic).
- Cohort 1 only: People who are willing and eligible to take a low-dose blood-clot prevention medication (a specific type of oral or injectable blood thinner) for the first 4 months of treatment, in line with relevant clinical guidelines.
- Cohort 2 – Second-line treatment for a specific EGFR mutation: People whose EGFR mutation is specifically an Ex19del or Ex21 L858R type, whose doctor has determined that amivantamab (given by infusion) and chemotherapy is the appropriate treatment, and whose cancer has continued to grow or returned after previous treatment that included a targeted therapy drug called an EGFR TKI.
- Cohort 3 – First-line treatment for a different EGFR mutation: People whose EGFR mutation is specifically an EGFR Ex20 insertion type, whose doctor has determined that amivantamab (given by infusion) and chemotherapy is the appropriate treatment, who have not previously received treatment for their advanced or metastatic lung cancer, and whose cancer cannot be treated with the aim of a cure through surgery or radiation (prior adjuvant or neoadjuvant therapy is permitted if the last dose was given more than 12 months before the cancer became locally advanced or metastatic).
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.
- People who are currently pregnant or breastfeeding.
- People who are already enrolled in another interventional clinical study.
- People who, in the treating doctor's judgement, have any condition that would make participation not in their best interest, or that could affect their wellbeing or interfere with the study assessments.
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.
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.
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Trial details
Status
Not Yet Recruiting
Phase
Phase 4
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Registry
ClinicalTrials.gov
Start date
30 April 2026
Est. completion
31 August 2029
Where this trial is recruiting
🇨🇳 China
Primary endpoints
The proportion of participants in 3 cohorts reporting improved/stable global health status of QoL score at 3 months
Can't join this trial?
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.
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.