A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201)

NCT05267470 on ClinicalTrials.gov Phase 1 Amgen (industry) Started 2022-03-29 Terminated

Riskier than 30% of active trials

Model scores of the 29,894 trials active now.

Model score 13% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2024-05-28, after 2022-03-29 start.

Reason given by the sponsor: “business”

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-05-28. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cellsquamoussmalllung cancerunresectable
Phrases that lowered it: participantsparticipantcombinationevaluate thefunction
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 12.6% (raises risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Has a data monitoring committee: not given (lowers risk) · Design
Maximum age: 99 (lowers risk) · Who can join
Drug's FAERS reports with a death: 16.8% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 61 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports before start: 257881 (lowers risk) · Drug's FDA history
Sponsor's past trials: 625 (raises risk) · Sponsor's track record
Drug's FAERS reports marked serious: 88.2% (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Number of arms: 4 (lowers risk) · Design
Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 1 (typical: 2)
Number of arms: 4 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: sequential (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 5 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 99 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 625 (typical: 32)
Sponsor's past termination rate: 12.6% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 61 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 4 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 257881 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 33780 (typical: 412.5)
Drug's FAERS reports marked serious: 88.2% (typical: 85.6%)
Drug's FAERS reports with a death: 16.8% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: bemarituzumab, carboplatin, docetaxel, paclitaxel, pembrolizumab

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

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A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression NCT05325866 · started 2022 · scored riskier than 71% of active trials terminated
Bevacizumab or Pemetrexed Disodium Alone or In Combination After Induction Therapy in Treating Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer NCT01107626 · started 2010 · scored riskier than 95% of active trials completed
Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer With an FGFR Alteration NCT05253807 · started 2022 · scored riskier than 82% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.