A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With No… (NCT05801029) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epidermal Growth Factor Receptor Mutations
Hong Kong, Malaysia, Singapore60 participantsStarted 2023-07-18
Plain-language summary
This study will assess the safety and efficacy of Osimertinib with Amivantamab as First-line Treatment in Participants with Epidermal Growth Factor Receptor Mutation-Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC).
Who can participate
Age range
18 Years – 130 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically documented non-squamous NSCLC. NSCLC of mixed histology is allowed.
* Newly diagnosed locally advanced or metastatic NSCLC or recurrent non-squamous NSCLC, not amenable to curative surgery or radiotherapy.
* WHO PS of 0 to 1 with no deterioration over the 2 weeks prior to enrolment.
* Minimum life expectancy \> 12 weeks at Day 1.
* Confirmation by the local laboratory that the tumour harbours one of the 2 common EGFRm known to be associated with (Epidermal Growth Factor Receptor- Tyrosine Kinase Inhibitor) EGFR-TKI sensitivity.
* At least 1 lesion that can be accurately measured at baseline as ≥10 mm in the longest diameter with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements.
* Contraceptive use by males or females should be consistent with local regulations
Exclusion Criteria:
* Any evidence of diseases, history of allogenic organ transplant, which in the investigator's opinion makes it undesirable for the participant to participate in the study or would jeopardise compliance with protocol.
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the osimertinib, or previous significant bowel resection that would preclude adequate absorption distribution, metabolism, or excretion of osimertinib.
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥2 y…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines osimertinib and amivantamab for NSCLC with EGFR mutations — how does my specific EGFR mutation type compare to what this study is targeting, and is this combination something worth exploring for my situation?
2Since this is a Phase 2 trial, what do we know so far about the safety profile of combining osimertinib and amivantamab, and are there any side effects from this combination that would be particularly important for me to be aware of given my overall health?
3The trial is no longer actively enrolling — does that mean there's no path to accessing this combination treatment, or are there other ways I might be able to receive osimertinib or amivantamab, either through a different trial or an approved regimen?
4One of the main things this study is measuring is progression-free survival — based on what's emerged so far, how does this combination compare to what I might expect from osimertinib alone, which is already an option for EGFR-mutated NSCLC?
5Given that enrollment is closed, would it make more sense for me to start on a current standard-of-care treatment now while we watch for results from this trial, rather than waiting to see if a follow-up study opens up?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with adverse events (AEs)
Timeframe: From screening (Day-28) to survival follow up (Approximately 52 months after the first participant is dosed)
2
Progression Free Survival (PFS)
Timeframe: From date of first dose of study intervention until radiological disease progression or death due to any cause (Approximately 52 months after the first participant is dosed)