AVAPERL1 Study: A Study of Avastin (Bevacizumab) With or Without Pemetrexed as Maintenance Therapy After Avastin in First Line in Patients With Non-Squamous Non-Small Cell Lung Cancer

NCT00961415 on ClinicalTrials.gov Phase 3 Hoffmann-La Roche (industry) Started 2009-08-31 Completed

Riskier than 26% of active trials

Model scores of the 29,894 trials active now.

Model score 12% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (1,463 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 2011-05-31, after 2009-08-31 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 2011-05-31. 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: squamouscellcancerrecurrentchemotherapy
Phrases that lowered it: kgand safetyopen labelm2efficacy and
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 11.9% (raises risk) · Sponsor's track record
Has a data monitoring committee: not given (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 189 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 18.7% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Design: parallel (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Number of arms: 3 (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Minimum age: 18 (raises risk) · Who can join
Keywords listed: 0 (lowers 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: 3 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: not given (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: 235 (typical: 32)
Sponsor's past termination rate: 11.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 189 (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: 21774 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 5541 (typical: 412.5)
Drug's FAERS reports marked serious: 91.3% (typical: 85.6%)
Drug's FAERS reports with a death: 18.7% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
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

Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer NCT00976456 · started 2009 · scored riskier than 52% of active trials completed
A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) NCT01351415 · started 2011 · scored riskier than 25% of active trials completed
Pemetrexed Plus Bevacizumab in Non Small Cell Lung Cancer NCT00741221 · started 2008 · scored riskier than 76% of active trials completed
A Feasibility Trial of Avastin (Bevacizumab) in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Patients With Locally Advanced Non-Squamous Non-Small Cell Lung Cancer. NCT00773188 · started 2008 · scored riskier than 18% of active trials completed
A Study of Avastin (Bevacizumab) in Combination With Carboplatin-Based Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer. NCT00700180 · started 2008 · scored riskier than 27% 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.