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
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.
I. General Exclusion Criteria (Applicable to All Phases)
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.
Parallel
AMT-116
DrugAMT-116 will be administered at 4 mg/kg or 5 mg/kg as an intravenous (IV) infusion on Day 1 of each 2-week cycle.
Investigator's choice regimens (docetaxel or docetaxel plus ramucirumab)
DrugDocetaxel will be administered as an IV infusion of 75 mg/m2 over approximately 60 minutes on Day 1 of each 3-week cycle. Ramucirumab will be administered as an IV infusion of 10 mg/kg over 30-60 minutes on Day 1 of each 3-week cycle prior to docetaxel
Number of Participants with Adverse Events as Assessed by CTCAE v6.0
Objective response rate (ORR)
Progression free survival (PFS)
Duration of response (DOR)
Disease control rate (DCR)
Correlation of PFS with baseline tumor CD44v9 expression
Correlation of ORR with baseline tumor CD44v9 expression
Correlation of DOR with baseline tumor CD44v9 expression
Correlation of DCR with baseline tumor CD44v9 expression
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This trial is not recruiting at the moment. You can still explore other options:
