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

Part of paid clinical trials in Port Saint Lucie, Florida.

Sponsor
Multitude Therapeutics Inc.
Study ID
NCT07718737
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • NSCLC (Advanced Non-small Cell Lung Cancer)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • AMT-116 — DRUG
    AMT-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) — DRUG
    Docetaxel 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

Study Details

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

Key Dates

First listed
Jul 22, 2026
Start date
Aug 28, 2026
Status verified
Jul 2026
Primary completion
Mar 30, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
512 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AMT-116 4 mg/kg
  • Experimental: AMT-116 5 mg/kg
  • Active Comparator: Investigator's choice of therapy (docetaxel or docetaxel plus ramucirumab)

Primary Outcome Measure

Number of Participants with Adverse Events as Assessed by CTCAE v6.0 [ Time Frame: About 7 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Hematology Oncology Associates of the Treasure CoastPort Saint LucieFlorida34952
Seth Rosen
[email protected]
540.371.0079
Lumi ResearchKingwoodTexas77339
David Nguyen
[email protected]
608-504-3799

Find similar trials in Port Saint Lucie, FL

By research site
Hematology Oncology Associates of the Treasure Coast· Port Saint Lucie, FLLumi Research· Kingwood, TX

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