New radioactive tracer could spot lung cancer mutations
NCT ID NCT07500987
First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This early-stage trial tests a radioactive imaging agent called [111In]-FPI-2107 in 12 Chinese adults with EGFR-mutant non-small cell lung cancer. The goal is to see if it is safe and can help detect tumors on SPECT scans. Participants receive the agent plus an unlabelled antibody beforehand. The study does not aim to treat cancer, only to improve diagnosis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [111In]-FPI-2107 (radioactive imaging agent) and FPI-2053 (unlabelled antibody pre-dose)
- What this could lead to
- If successful, this could lead to a better way to detect EGFR-mutant lung cancer using imaging, helping guide treatment decisions.
- What could go wrong
- This is a very early Phase I trial with only 12 participants, focused on safety and imaging properties, not treatment. It may not lead to a widely used diagnostic tool.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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6 people
The number who actually took part.
- Started
-
Feb 2026
- Finished
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May 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 130 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically or cytologically confirmed EGFR mutation positive NSCLC. * Without any ongoing anti-cancer therapy or with stable ongoing anti-cancer therapy. * At least one lesion that is present on 18F-FDG PET/CT scan during screening. * ECOG performance status of 0 or 1. * Anticipated life expectancy ≥ 12 weeks, in the opinion of the Investigator. * Able to provide tumour tissue for analysis. Exclusion Criteria: * Confirmed radiographic disease progression or Investigator-assessed clinical disease progression within 28 days prior to the administration of \[111In\]-FPI-2107. * Contraindications to or inability to perform the imaging procedures required in this study. * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (≥ once per month). * History of myocardial infarction or New York Heart Association Class II-IV congestive heart failure within 6 months of the administration of \[111In\]-FPI-2107, CTCAE Grade 2 or worse conduction defect or uncontrolled hypertension. * Clinically relevant proteinuria, or daily urinary protein excretion \> 500 mg). * Any antibody-based therapy targeting EGFR and/or c-MET, or investigational agent within 28 days or 5 half-lives prior to the administration of \[111In\]-FPI-2107, whichever is shorter. * Any systemic radiopharmaceutical within 28 days or 5 radioactive half-lives prior to the administration of \[111In\]-FPI-2107, whichever is shorter. * Any anticipated need for switching of any concomitant anti-cancer therapy during the imaging period of the study. * External beam radiation therapy within 28 days prior to the administration of \[111In\]-FPI-2107.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Research Site
Beijing, 100142, China
-
Research Site
Shandong, China
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Research Site
Wuhan, 430022, China