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Radioisotope Therapy

177Lu-FAP-2286 for Solid Cancers (LuMIERE Trial)

Phase 1 & 2
Waitlist Available
Led By Thomas Hope, MD
Research Sponsored by Clovis Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For Phase 2: Have cytologically or histologically and radiologically confirmed recurrent or metastatic disease as outlined
Be ≥ 18 years of age at the time the ICF is signed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)
Awards & highlights

LuMIERE Trial Summary

This trial will study a new cancer treatment to see if it is safe and effective.

Who is the study for?
This trial is for adults with advanced solid tumors that have worsened after treatment or don't respond to it. They should be in good physical condition, not pregnant, and willing to use contraception. People with active secondary cancers, brain metastases, recent cancer treatments or surgeries, ongoing serious side effects from past treatments (except hair loss), severe urinary issues, known allergies to scan contrast media, infections needing antibiotics recently, significant heart problems are excluded.Check my eligibility
What is being tested?
The study tests the safety and ideal dose of a new drug called 177Lu-FAP-2286 in Phase 1 and its effectiveness at shrinking tumors in Phase 2. Patients must have specific FAP-expressing tumor types for Phase 2. The response rate will be measured using standard criteria.See study design
What are the potential side effects?
Possible side effects include reactions related to bone marrow suppression (like anemia), liver or kidney function impairment due to the drug's toxicity profile; however exact side effects aren't listed as this is a phase I/II trial determining safety.

LuMIERE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has returned or spread and this is confirmed by tests.
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I am 18 years old or older.
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My organ functions are within normal ranges according to recent tests.
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My cancer is advanced, cannot be cured with treatment, and has been confirmed by tests.
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I am fully active or restricted in physically strenuous activity but can do light work.

LuMIERE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Dose-limiting toxicity (DLTs)
Phase 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of [177Lu]Lu FAP 2286
Phase 1: recommended Phase 2 dose (RP2D)
+4 more
Secondary outcome measures
Phase 1: Absorbed dose (Gy) estimated in organs and tumor lesions
Phase 1: Area under the curve (AUC) of [177Lu]Lu FAP 2286
Phase 1: Clearance (CL) of [177Lu]Lu FAP 2286
+14 more

LuMIERE Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2: Specific Solid TumorsExperimental Treatment2 Interventions
Up to 192 participants treated with [177Lu]Lu-FAP-2286 in tumor-specific participant groups in monotherapy and in combination with chemotherapy.
Group II: Phase 1: Dose EscalationExperimental Treatment2 Interventions
Up to 30 patients with solid tumors.

Find a Location

Who is running the clinical trial?

Clovis Oncology, Inc.Lead Sponsor
64 Previous Clinical Trials
11,449 Total Patients Enrolled
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,128 Total Patients Enrolled
Thomas Hope, MDPrincipal InvestigatorUniversity of California, San Francisco
11 Previous Clinical Trials
2,011 Total Patients Enrolled

Media Library

177Lu-FAP-2286 (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04939610 — Phase 1 & 2
Solid Tumors Research Study Groups: Phase 1: Dose Escalation, Phase 2: Specific Solid Tumors
Solid Tumors Clinical Trial 2023: 177Lu-FAP-2286 Highlights & Side Effects. Trial Name: NCT04939610 — Phase 1 & 2
177Lu-FAP-2286 (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04939610 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the objectives of this experiment?

"The objective of this study is to assess the efficacy of 177Lu-FAP-2286 in advanced solid tumors. The primary outcome will be Objective Response Rate (ORR), and secondary outcomes include Preliminary Efficacy and Overall Survival. PK assessments will also be conducted to evaluate the pharmacokinetics of the study drug."

Answered by AI

Could you please tell me if there is any other research being done with 177Lu-FAP-2286?

"333At this moment, there are 33 active clinical trials investigating 177Lu-FAP-2286. 3 of these studies have progressed to Phase 3. The majority of the research being conducted for 177Lu-FAP-2286 is based in Perth, Western Australia; however, there are a total of 241 different locations running clinical trials involving this compound."

Answered by AI

How many people total will be included in this clinical trial?

"The information available on clinicaltrials.gov does indicate that this particular trial is ongoing and recruiting patients. This specific study was uploaded to the site on 7/30/2021 and was last updated 8/26/2022. There are a total of 170 participants needed, which will be recruited from 6 different locations."

Answered by AI

Are there any available positions for trial participants?

"Yes, the trial is still recruiting patients. It was posted on 7/30/2021 and most recently updated on 8/26/222. They are looking for 170 individuals to participate at 6 clinical sites."

Answered by AI

Could you please outline how many different locations are conducting this research project?

"There are currently six sites where patients can enroll in this trial, which include University of Iowa Hospitals and Clinics in Iowa City, UAB Comprehensive Cancer Center in Birmingham, Columbia University Medical Center in New york. The other enrolment locations are as follows: ____, ____, ____ , ____ , ____."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of 177Lu-FAP-2286 in Advanced Solid Tumors (LuMIERE)
2021. "A Study of 177Lu-FAP-2286 in Advanced Solid Tumors (LuMIERE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04939610.
~98 spots leftby Jun 2026
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