RecruitingPhase 2 / Phase 3NCT07718737
Official study title

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

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAMT-116 and Investigator's choice regimens (docetaxel or docetaxel plus ramucirumab)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · PD-L1

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 26, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 2 / Phase 3

Interventional

Where is it offered?7 U.S. locations

Locations may change over time.

Who runs it?Multitude Therapeutics Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2 / Phase 3
Sponsor
Multitude Therapeutics Inc.
Interventions being studied
Drug: AMT-116; Drug: Investigator's choice regimens (docetaxel or docetaxel plus ramucirumab)
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 1. 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. 2. Age between 18 and 80 years old (including 18 and 80 years old) at the time of signing the informed consent form. 3. 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. 4. 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. 5. 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. 6. 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: 6.1 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. 6.2 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. 6.3 Patients with gene mutations for which immunotherapy is a conventional treatment: Have also experienced disease progression after immune checkpoint inhibitor therapy (used alone or combined with chemotherapy), or are not suitable for immunotherapy clinically. 7. The investigator confirms that the patient is suitable for docetaxel treatment (only applicable for Phase 3 trial). 8. Have at least one measurable tumor lesion assessed by RECIST 1.1 criteria. 9. ECOG physical status score is 0 or 1, with normal daily physical activity. 10. Expected survival time is at least 12 weeks. 11. Have normal and stable organ function. No blood transfusion, erythropoietin, thrombopoietin, granulocyte colony-stimulating factor or other supportive treatment within 14 days before the test, and meet the following laboratory standards:
  • Blood routine: Absolute neutrophil count ≥ 1.5 × 10/L; platelet count ≥ 100 × 10/L; hemoglobin ≥ 90 g/L
  • Renal function: Creatinine clearance ≥ 50 mL/min (calculated by Cockcroft-Gault formula)
  • Liver function: Total bilirubin ≤ 1.5 times the upper limit of normal (or ≤ 3 times the upper limit of normal for patients with Gilbert's disease); AST and ALT ≤ 2.5 times the upper limit of normal (or ≤ 5 times the upper limit of normal for patients with liver metastases)
  • Coagulation function: INR or aPTT ≤ 1.5 times the upper limit of normal for patients not receiving anticoagulant treatment 12. Female patients of childbearing age must use two effective contraceptive methods during the trial treatment period and within 12 weeks after the last dose of trial drug. A negative serum pregnancy test is required within 7 days before enrollment. Postmenopausal women (no menstruation for 12 consecutive months) or surgically sterilized women are exempted. 13. Male patients must use latex condoms during treatment and within 12 weeks after the last dose of trial drug (even after vasectomy). All patients are prohibited from donating sperm (male) or eggs (female) during the trial and within 12 weeks after the last drug dose.
Reasons someone may not be able to joinExclusion criteria

I. General

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • Hematology Oncology Associates of the Treasure CoastPort Saint Lucie, Florida
  • Lumi ResearchKingwood, Texas
  • Coffs Harbour Health CampusCoffs Harbour
  • Austin Health (Olivia Newton John Cancer Centre)Melbourne
  • St Vincent's Hospital MelbourneMelbourne
  • Calvary Mater NewcastleNewcastle
  • Macquarie University HospitalSydney

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 26, 2026. Always confirm current availability with the study team.

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