MedTrace Logo

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

NCT07718737 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2026-08-10

No results posted yet for this study

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

Conditions

  • NSCLC (Advanced Non-small Cell Lung Cancer)

Interventions

DRUG

AMT-116

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.

DRUG

Investigator's choice regimens (docetaxel or docetaxel plus ramucirumab)

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

Sponsors & Collaborators

  • Multitude Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-28
Primary Completion
2028-03-30
Completion
2028-12-30
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07718737 on ClinicalTrials.gov