NCT06228482

Brief Summary

This is a Phase I study to evaluate the safety and efficacy of the \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G theranostics pair in patients with metastatic non small cell lung cancer (NSCLC).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
7mo left

Started Jan 2024

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Jan 2024Jan 2027

First Submitted

Initial submission to the registry

January 18, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

January 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.9 years

First QC Date

January 18, 2024

Last Update Submit

February 23, 2026

Conditions

Metastatic Nonsmall Cell Lung Cancer

Keywords

integrinmetastatic NSCLCPETtheranostic

Outcome Measures

Primary Outcomes (3)

  • [68Ga]Ga DOTA-5G PET/CT imaging

    To assess the ability of \[68Ga\]Ga DOTA-5G to detect lesions in patients with metastatic NSCLC

    2 hours from time of injection

  • [177Lu]Lu DOTA-ABM-5G treatment

    To assess the safety and tolerability of a single treatment with \[177Lu\]Lu DOTA-ABM-5G

    30 days from time of treatment

  • [177Lu]Lu DOTA-ABM-5G treatment efficacy

    To assess treatment efficacy (response vs. no response) assessed by comparison with a post-treatment scan (standard of care imaging and post second \[68Ga\]Ga DOTA-5G PET/CT, prior to next line of therapy.

    60 days from time of treatment

Study Arms (1)

[177Lu]Lu DOTA-ABM-5G single dose therapy study

EXPERIMENTAL

Patients will be undergo \[68Ga\]Ga DOTA-5G PET/CT scans to confirm eligibility for the \[177Lu\]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of \[68Ga\]Ga DOTA-5G PET/CT will be offered therapy.

Drug: [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.

Interventions

[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.DRUG

Patients will be undergo \[68Ga\]Ga DOTA-5G PET/CT scans to confirm eligibility for the \[177Lu\]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of \[68Ga\]Ga DOTA-5G PET/CT will be offered therapy. Patients will undergo a follow up \[68Ga\]Ga DOTA-5G PET/CT scans to assess tretament efficacy.

Also known as: [68Ga]Ga DOTA-5G, [177Lu]Lu DOTA-ABM-5G, [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G theranostic pair
[177Lu]Lu DOTA-ABM-5G single dose therapy study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to understand and willingness to sign a written informed consent document.
  • Age 18 or more years
  • Pathologically confirmed NSCLC with metastatic disease and measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion \> 1 cm or lymph node \> 1.5 cm in short axis)
  • Participant must have documented tumor progression for metastatic disease during or following at least one prior FDA approved systemic regimen as established by diagnostic imaging.
  • Available archival tumor tissue (excisional, core, or FNA is acceptable). Tissue from a metastatic site is preferred when available.
  • Eastern Cooperative Oncology Group Performance Status ≤ 2
  • Participant must have completed prior systemic therapy at least 2 weeks (washout period) prior to \[68Ga\]Ga DOTA-5G PET scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to Grade 1 or baseline.
  • Hematologic parameters defined as:
  • Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 8 g/dL
  • Blood chemistry levels defined as:
  • AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 2 times ULN Creatinine ≤ 2 times ULN
  • Anticipated life expectancy ≥ 3 months
  • Able to remain motionless for up to 30-60 minutes per scan
  • Completion of entry into \[68Ga\]Ga DOTA-5G PET study and completion of scan
  • The presence of at least one measurable disease by \[68Ga\]Ga DOTA-5G PET/CT (SUVmax\>2-fold above normal bone, brain, lung or liver and identified on standard of care diagnostic imaging) Patients with a history of brain metastases and or any clinical concern for brain metastases will be evaluated with brain MRI as per standard of care for patients with metastatic NSCLC.

You may not qualify if:

  • Participants with Class 3 or 4 NYHA Congestive Heart Failure
  • Clinically significant bleeding within two weeks prior to trial. entry (e.g. gastrointestinal bleeding, intracranial bleeding)
  • Pregnant or lactating women
  • Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks
  • Has an additional active malignancy requiring therapy within the past 2 years (other than early stage, surgically managed basal and squamous skin cancer and in situ malignancies of the breast and cervix)
  • Active, uncontrolled bacterial, viral, or fungal infection(s) despite systemic therapy
  • Psychiatric illness/social situations that would interfere with compliance with study requirements
  • Cannot undergo PET/CT or SPECT/CT scanning because of weight limits (350 lbs.)
  • Known interstitial lung disease or pre-existing pulmonary fibrosis
  • INR \>2.0: PTT\>15 seconds above ULN

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Julie L Sutcliffe, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie L Sutcliffe, Phd

CONTACT

9167345536jlsutcliffe@ucdavis.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 18, 2024

First Posted

January 29, 2024

Study Start

January 22, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)