Global, Multicenter Study of AMT-116 Versus Investigator's Choice in Participants With Advanced o… (NCT07718737) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Global, Multicenter Study of AMT-116 Versus Investigator's Choice in Participants With Advanced or Metastatic Non-squamous EGFR-Wildtype Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy
United States, Australia512 participantsStarted 2026-08-28
Plain-language summary
This clinical trial consists of two parts: phase 2 and phase 3.
The goal of phase 2 of this clinical trial is to compare which dose level of AMT-116 works better to treat advanced or metastatic non-squamous EGFR-Wildtype non-small cell lung cancer (NSCLC) in adults. It will also learn about the safety of AMT-116. The main questions it aims to answer are:
* Which level of AMT-116 works better to treat advanced or metastatic non-squamous EGFR-Wildtype NSCLC?
* What medical problems do participants have when taking AMT-116? The goal of phase 3 of this clinical trial is to compare AMT-116 to study doctor's choice (a kind of retainable treatment for you in the opinion of the study doctor) to see if AMT-116 works better to treat advanced or metastatic non-squamous EGFR-Wildtype NSCLC.
In both parts of this trial, participants will receive AMT-116 or study doctor's choice every 2 weeks until the study doctor thinks you are benefiting from your participation or until your disease progresses or you are unable to tolerate the study drug
Who can participate
Age range
18 Years – 80 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
. Voluntarily agree to join this clinical trial, sign the informed consent form, and follow all trial arrangements, including scheduled hospital visits, examinations and other study requirements.
. Age between 18 and 80 years old (including 18 and 80 years old) at the time of signing the informed consent form.
. Diagnosed with non-squamous non-small cell lung cancer (NSCLC) confirmed by pathological or cytological tests. The disease must be either locally advanced and unresectable (not suitable for radical chemoradiotherapy) or metastatic advanced lung cancer.
. Must have a clear EGFR gene test result before enrollment. Patients with other actionable gene mutations (excluding EGFR mutation) are eligible. Testing for other genes is not mandatory, and can be performed according to local hospital routine standards and available treatment options.
. Have received no more than one line of chemotherapy for advanced or metastatic lung cancer. Neoadjuvant or adjuvant chemotherapy will be counted as one prior chemotherapy line if the disease progresses within 6 months after the end of treatment.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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 as Assessed by CTCAE v6.0
. Have received at least one prior formal treatment (chemotherapy, targeted therapy or immunotherapy) for advanced or metastatic lung cancer, with subsequent disease progression or recurrence. Participants must meet the corresponding requirements based on their genetic status:
.1 Patients without any actionable gene mutations: Have experienced disease progression after platinum-based chemotherapy and immune checkpoint inhibitor therapy (used alone or combined with chemotherapy), or are not suitable for the above two treatments clinically.
.2 Patients with gene mutations that do not routinely use immunotherapy (e.g., ALK fusion): Have experienced disease progression after targeted therapy for gene mutations and platinum-based chemotherapy, or are not suitable for the above two treatments clinically.
Exclusion criteria
. Prior treatment with antibody-drug conjugates (ADCs) based on topoisomerase 1 inhibitors.
. Receipt of any systemic anti-cancer therapy within the shorter period between five half-lives of the drug or 21 days prior to randomization is prohibited.
. Tumor pathology confirms adenosquamous, neuroendocrine, or sarcomatoid features.
. Presence of actionable activating mutations in the epidermal growth factor receptor (EGFR) gene.
. Non-small cell lung cancer (NSCLC) patients who are eligible for definitive local therapy alone (e.g., selected stage IIIA patients) are excluded.
. Central nervous system (CNS) metastases:
. Unresolved toxicities of Grade \> 1 caused by prior systemic anti-cancer treatment.
. Receipt of wide-field radiotherapy (e.g., irradiation covering more than 30% of bone marrow-bearing bones) within 28 days prior to randomization, or palliative radiotherapy for symptom control within 2 weeks prior to randomization.