[18F]DCFPyL in Renal Cell Carcinoma: NCT07084909 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 28 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 2/3
Clinical phase
Withdrawn
Recruitment status
0
Planned enrollment
2027-09-01
Primary-completion proxy
Executive view
NCT07084909 evaluates [18F]DCFPyL in Renal Cell Carcinoma. The disclosed sponsor is Lantheus Medical Imaging, Inc., the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is Phase 2 Primary Objective - Establishing the optimum dose and timing window of piflufolastat F18 for detection of metastatic disease, assessed over On Day 1 (day of injection) where Piflufolastat F18 will be administered at a target dose of 9 mCi [+/-1 mCi]) after which patients will be scanned at 60-90 minutes and again at 3-4 hours..
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07084909 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Renal Cell Carcinoma landscape. Drug & Asset MCP drug_fetch was queried for [18F]DCFPyL, while Company & Deal Intelligence MCP organization_fetch was queried for Lantheus Medical Imaging, Inc..
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT07084909 | [18F]DCFPyL | Phase 2/3 / Withdrawn | Lantheus Medical Imaging, Inc. | United States | Phase 2 Primary Objective - Establishing the optimum dose and timing window of piflufolastat F18 for detection of metas… On Day 1 (day of injection) where Piflufolastat F18 will be administe… | 2027-09-01 |
| NCT07218692 | RP-2(Replimune Group) | Phase 2 / Not yet recruiting | City of Hope National Medical Center | United States | Objective response rate Up to 2 years | 2027-08-11 |
| NCT07195682 | Ipilimumab | Phase 1 / Recruiting | Bristol Myers Squibb Co. | Canada, United States, Italy, France, Spain | Number of Participants With Adverse Events (AEs) Up to approximately 2 years from first dose of BMS-986506 | 2030-05-03 |
| NCT07197580 | Lutetium-177 DOTA girentuximab | Phase 3 / Recruiting | Telix Pharmaceuticals Ltd. | Australia | Dose Optimization -safety and tolerability Through study completion, an average of 1.5 years | 2027-08-31 |
| NCT07187778 | Belzutifan | Phase 2 / Recruiting | The University of Texas MD Anderson Cancer Center | United States | 1. Safety and Adverse Events (AEs) Through study completion; an average of 1 year | 2027-07-19 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT07084909 is a Phase 2/3, withdrawn study with 0 planned participants. Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Sequential Assignment.
The primary endpoint is “Phase 2 Primary Objective - Establishing the optimum dose and timing window of piflufolastat F18 for detection of metastatic disease” over “On Day 1 (day of injection) where Piflufolastat F18 will be administered at a target dose of 9 mCi [+/-1 mCi]) after which patients will be scanned at 60-90 minutes and again at 3-4 hours..” The retrieved endpoint description is: Defining the optimal dose and scan timing window for Piflufolastat F18 PET/CT.
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 0 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Renal Cell Carcinoma. These records do not establish direct evidence for NCT07084909 unless the registration number matches.
A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cel…
Phase 3; n=681; Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale(Geometric Mean): Adjusted Geometric Mean Ratio = 2.098(90% CI, 2.001 - 2.200); Adjusted Geometric Mean Ratio = 0.999(90% CI, 0.915 - 1.090); Adjusted Geometric Mean Serum Concentration of Nivolumab Over 28 Days (Cavgd28) on Original Scale(Geometric Mean) = 75.504 μg/mL (90% Confidence Interval, 70.941 - 80.361) Source: https://clinicaltrials.gov/ct2/show/results/NCT04810078
Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma
Phase 2; n=10; ORR = 0 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT03274258
High Dose IL-2 in Combination With Anti-PD-1 to Overcome Anti-PD-1 Resistance in Metastatic Melanoma and Renal Cell Carcinoma
Phase 2; n=6; ORR = 1 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT03991130
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
[18F]DCFPyL is indexed as Small molecule drug with PSMA biology and a global stage of Approved. The asset profile lists Progenics Pharmaceuticals, Inc. as an originator or developer.
Lantheus Medical Imaging, Inc. is indexed in United States with the website https://www.lantheus.com. Develops and manufactures radio diagnostics The record lists 12 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether [18F]DCFPyL is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT07084909
Protocol source: https://clinicaltrials.gov/study/NCT07084909
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 28 September 2026.
[18F]DCFPyL in Renal Cell Carcinoma is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Phase 2 Primary Objective - Establishing the optimum dose and timing window of piflufolastat F18 for detection of metastatic disease and 2027-09-01 the leading decision points.
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