A Study of Pemetrexed and Bevacizumab for Participants With Advanced Non-Small Cell Cancer

NCT01004250 on ClinicalTrials.gov Phase 2 Eli Lilly and Company (industry) Started 2009-10-31 Completed

Riskier than 35% of active trials

Model scores of the 29,894 trials active now.

Model score 14% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (1,598 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

How it ended

Completed on 2013-12-31, after 2009-10-31 start.

The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

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 2013-12-31. 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: stagensclcbrainadvancedimaging
Phrases that lowered it: bevacizumabenrollmentdexamethasoneopendays
Sponsor's past termination rate: 3.8% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Trials the sponsor started in the prior 2 years: 156 (lowers risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Sponsor's past trials: 420 (lowers risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Design: single group (raises risk) · Design
Drug's FAERS reports with a death: 18.8% (lowers risk) · Drug's FDA history
Maximum age: not given (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Number of arms: 1 (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Minimum age: 18 (raises risk) · Who can join
Responsible party: sponsor (lowers risk) · Design
Collaborators: 0 (raises risk) · Design

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: 2
Number of arms: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: not given (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: 420 (typical: 32)
Sponsor's past termination rate: 3.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 156 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 22610 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 5632 (typical: 412.5)
Drug's FAERS reports marked serious: 91.6% (typical: 85.6%)
Drug's FAERS reports with a death: 18.8% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, respiratory
Drugs matched to FDA substances: bevacizumab, cisplatin, pemetrexed

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

Trial of Poor Performance Status Patients (ToPPS) NCT00892710 · started 2009 · scored riskier than 68% of active trials completed
A Study of Pemetrexed and Gefitinib Versus Gefitinib in Non-Small Cell Lung Cancer (NSCLC) NCT01469000 · started 2012 · scored riskier than 44% of active trials completed
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
Trial of Bevacizumab and Ixabepilone for Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) NCT01057212 · started 2010 · scored riskier than 93% of active trials terminated
Platinum-Based Chemotherapy Plus Ramucirumab in Patients With Advanced NSCLC Who Have Progressed on First Line Anti-PD-1 Immunotherapy NCT03904108 · started 2019 · scored riskier than 88% of active trials terminated

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.