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NSCLC (Advanced Non-small Cell Lung Cancer)Phase 2/3NCT07718737

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

A Phase 2/3 study testing AMT-116 and Investigator's choice regimens (docetaxel or docetaxel plus ramucirumab) in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Multitude Therapeutics Inc. at 7 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
AMT-116 and Investigator's choice regimens (docetaxel or docetaxel plus ramucirumab)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
512 participants
Where
7 sitesin 2 countries
Study dates
30 Sep 2026to 30 Dec 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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:
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  • 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.
  • The investigator confirms that the patient is suitable for docetaxel treatment (only applicable for Phase 3 trial).
  • Have at least one measurable tumor lesion assessed by RECIST 1.1 criteria.
  • ECOG physical status score is 0 or 1, with normal daily physical activity.
  • Expected survival time is at least 12 weeks.
  • 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
  • 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.
  • 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.

Who cannot join

  • 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.
  • Notes:
  • ① If the half-life of an investigational agent has not been determined, its administration within 21 days prior to randomization is not allowed.
  • ② Patients receiving bisphosphonates or denosumab may continue these medications during the study and are not excluded.
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  • 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:
  • ① Patients with CNS metastases are eligible only if all the following conditions are fully met: the CNS metastases have been treated with surgical resection and/or radiotherapy at least 28 days prior to randomization; and post-treatment evaluation satisfies all three requirements below: (1) No cerebral edema is observed in screening examinations, and no ongoing need for systemic steroids or anticonvulsant medications; (2) Neurological symptoms are absent or stable (Grade ≤ 1); (3) Follow-up imaging conducted within 28 days prior to randomization shows no progression of treated lesions and no new lesions.
  • ② Note: Patients with a history of leptomeningeal disease are strictly excluded.
  • Unresolved toxicities of Grade > 1 caused by prior systemic anti-cancer treatment.
  • Note: Patients with Grade ≤ 2 peripheral neuropathy, alopecia of any grade, endocrinopathy well-managed by hormone replacement therapy, or other toxicities judged to pose no safety risks by the investigator are eligible for enrollment.
  • 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.
  • Undergoing major surgery (excluding vascular access device placement and tumor biopsy) within 28 days prior to randomization, or failure to fully recover from postoperative side effects of such surgery.
  • Presence of severe cardiac diseases, including myocardial infarction or acute coronary syndrome (including unstable angina) within 6 months prior to randomization, New York Heart Association (NYHA) Class III/IV congestive heart failure, uncontrolled hypertension, or uncontrolled cardiac arrhythmia.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis; or active pneumonitis identified on screening chest computed tomography (CT). A history of radiation-induced pulmonary fibrosis within the previous radiation field is permitted.
  • History of thromboembolic or cerebrovascular events within 6 months prior to randomization, including transient ischemic attack, stroke, deep vein thrombosis (DVT), and pulmonary embolism (PE).
  • Note: Patients diagnosed with DVT or PE within the above 6-month window may be eligible if they have received standardized anticoagulant treatment (or discontinued anticoagulants when clinically unnecessary) and show no evidence of active disease at screening.
  • Presence of acute or clinically significant bacterial, fungal, or viral infections, including active hepatitis B (HBV), hepatitis C (HCV), or confirmed human immunodeficiency virus (HIV) infection.
  • Note: Patients with chronic HBV, HCV, or HIV infection may be enrolled upon mutual approval by the investigator and sponsor, provided they meet one of the following criteria:
  • HIV-positive patients have received stable antiretroviral therapy (ART) for at least 28 days, with CD4+ T-cell count ≥ 350 cells/μL and HIV viral load < 400 copies/mL;
  • Patients with chronic HBV infection are on concurrent anti-HBV treatment with HBV viral load below the quantitative limit;
  • Patients with prior HCV infection have completed curative anti-HBV treatment with HCV viral load below the quantitative limit;
  • Patients receiving ongoing anti-HCV treatment have HCV viral load below the quantitative limit.
  • Receipt of live vaccine within 28 days prior to randomization.
  • Requirement for concurrent treatment with strong or moderate cytochrome P450 3A4 (CYP3A4) inhibitors within 1 week prior to the first study drug dose or during the entire treatment period (see Appendix 6 for detailed list).
  • Known or suspected intolerance or hypersensitivity to any components of the investigational medicinal product (IMP).
  • Active alcohol or illicit drug abuse.
  • Female patients who are pregnant or breastfeeding.
  • Presence of any mental or medical condition that impairs the ability to provide informed consent or comply with trial requirements; or any severe acute/chronic medical, psychiatric disease or laboratory abnormality that may increase trial-related risks, interfere with study result interpretation, or is deemed inappropriate for enrollment by the investigator.
  • History of other malignant tumors (excluding the study indication cancer) within 5 years prior to randomization.
  • Note: Patients with adequately treated basal cell skin cancer, non-invasive superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, or prostate carcinoma in situ are eligible if no active disease has been observed for 2 years prior to randomization.
  • Phase 3 Specific Exclusion Criteria
  • Prior treatment with docetaxel as monotherapy or combination therapy.
  • Radiological evidence of major blood vessel invasion or encasement by tumor.
  • Radiological evidence of intratumoral cavitation.
  • History of uncontrolled hereditary or acquired thrombotic disorders.
  • Receipt of therapeutic anticoagulation with warfarin, low-molecular-weight heparin, or similar agents. Patients receiving low-dose prophylactic anticoagulation are eligible if they meet the coagulation parameter requirements specified in inclusion criterion 11.
  • Receipt of continuous antiplatelet or anticoagulant therapy (excluding prophylactic anticoagulation for venous patency maintenance) within 2 weeks prior to randomization. Aspirin at a daily dose of up to 325 mg is permitted.
  • Presence of severe unhealed wounds, ulcers, or bone fractures within 28 days prior to randomization.
  • Presence of significant bleeding disorders, vasculitis, or Grade 3/4 gastrointestinal bleeding within 3 months prior to randomization.
  • History of gross hemoptysis (defined as bright red blood sputum or blood volume ≥ 1/2 teaspoon) within 2 months prior to randomization.
  • History of gastrointestinal perforation and/or fistula formation within 6 months prior to randomization.

Trial locations and contacts

7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Yanhong Fu contact

+86 13952922547

yanhong.fu@multitudetherapeutics.com

7 sites in 2 countries

Australia5 sites, 5 recruiting

  • Coffs Harbour Health Campus

    Coffs Harbour

    Dr Karen Briscoe, 429234338, karen.briscoe@health.nsw.gov.au

    Not yet recruiting

  • Austin Health (Olivia Newton John Cancer Centre)

    Melbourne

    Dr Sagun Parakh, (03) 9496 5000, Sagun.PARAKH3@austin.org.au

    Not yet recruiting

  • St Vincent's Hospital Melbourne

    Melbourne

    Dr Melissa Moore, 392313167, Melissa.Moore@svha.org.au

    Not yet recruiting

  • Calvary Mater Newcastle

    Newcastle

    Dr Lucy Corke, 240143584, lucy.corke@health.nsw.gov.au

    Not yet recruiting

  • Macquarie University Hospital

    Sydney

    A/Prof John Park, +61 (2) 9850 4430, john.park@mqhealth.org.au

    Recruiting

Other trials in Australia

United States2 sites, 2 recruiting

  • Lumi Research

    Kingwood, Texas, 77339

    David Nguyen, 608-504-3799, bhavin@lumiresearch.com

    Not yet recruiting

  • Hematology Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida, 34952

    Seth Rosen, 540.371.0079, cgerdes@hemoncfl.com

    Not yet recruiting

Other trials in United States

About this study

Official title: Open-Label, Global, Multicenter, Randomized, Phase 2/3 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

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:

Read more
  • 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

Being tested
AMT-116, Investigator's choice regimens (docetaxel or docetaxel plus ramucirumab)
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMT-116Drug

    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 groups in NCT07718737
Study groupRoleWhat they receive
AMT-116 4 mg/kgExperimentalNot described
Receives: Drug: AMT-116
AMT-116 5 mg/kgExperimentalNot described
Receives: Drug: AMT-116
Investigator's choice of therapy (docetaxel or docetaxel plus ramucirumab)Active comparatorNot described
Receives: Drug: Investigator's choice regimens (docetaxel or docetaxel plus ramucirumab)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events as Assessed by CTCAE v6.0

    Measured: About 7 months

Secondary outcomes (9)

  1. Objective response rate (ORR)

    Measured: About 6 months

  2. Progression free survival (PFS)

    Measured: About 6 months

  3. Duration of response (DOR)

    Measured: About 6 months

  4. Disease control rate (DCR)

    Measured: About 6 months

  5. Peak and pre-dose trough concentrations (Cmax and Ctrough) over time for conjugated antibody

    Measured: About 6 months

  6. Peak and pre-dose trough concentrations (Cmax and Ctrough) over time for total antibody

    Measured: About 6 months

  7. Peak and pre-dose trough concentrations (Cmax and Ctrough) over time for released free payload

    Measured: About 6 months

  8. Peak and pre-dose trough concentrations (Cmax and Ctrough) over time for the anti-drug antibodies (ADAs)

    Measured: About 6 months

  9. Overall survival

    Measured: About 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2026
  2. Study start30 Sep 2026
  3. Primary completion30 Mar 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
512 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07718737
Sponsor's protocol ID
AMT-116-201
Status last verified
Jul 2026
First submitted
13 Jul 2026
Last updated
26 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing AMT-116 and Investigator's choice regimens (docetaxel or docetaxel plus ramucirumab) in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Multitude Therapeutics Inc. at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yanhong Fu (+86 13952922547, yanhong.fu@multitudetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events as Assessed by CTCAE v6.0 (time frame: About 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07718737.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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