BIBF 1120 in Combination With Pemetrexed in Advanced Non Small Cell Lung Cancer (NSCLC)

NCT00979576 on ClinicalTrials.gov Phase 1 Boehringer Ingelheim (industry) Started 2009-10-16 Terminated

Riskier than 16% of active trials

Model scores of the 29,894 trials active now.

Model score 10% 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 16% of the time (1,938 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

Terminated on 2015-02-16, after 2009-10-16 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 2015-02-16. 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: cellnsclcstagesmallthe past
Phrases that lowered it: patients who20japaneseand safetyefficacy and
Minimum age: 20 (lowers risk) · Who can join
Sponsor's past termination rate: 4.7% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 196 (lowers risk) · Sponsor's track record
Has a data monitoring committee: not given (lowers risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: 22.3% (raises risk) · Drug's FDA history
Maximum age: 74 (lowers risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Number of arms: 3 (lowers risk) · Design
Blinding: double (raises risk) · Design
Sponsor's past trials: 86 (lowers risk) · Sponsor's track record
Responsible party: sponsor (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: 1 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: double (typical: 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: 20 (typical: 18)
Maximum age: 74 (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: 86 (typical: 32)
Sponsor's past termination rate: 4.7% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 196 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 2169 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 496 (typical: 412.5)
Drug's FAERS reports marked serious: 88.0% (typical: 85.6%)
Drug's FAERS reports with a death: 22.3% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, respiratory
Drugs matched to FDA substances: 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

BIBF 1120 + Docetaxel (Japan) in Patients With Advanced Non-small-cell Lung Cancer, Phase I NCT00876460 · started 2009 · scored riskier than 14% of active trials completed
Lume Lung 2 : BIBF 1120 Plus Pemetrexed Compared to Placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC NCT00806819 · started 2008 · scored riskier than 45% of active trials completed
LUX-Lung 4: BIBW 2992 (Afatinib) Phase I Trial in Advanced Non Small Cell Lung Cancer Patients & Phase II Trial in Non Small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib NCT00711594 · started 2008 · scored riskier than 23% of active trials completed
An Dose Escalation Trial of Oral BIBF 1120 in Combination With Intravenous Carboplatin and Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer - Stage IV (VENUS-2) NCT01683682 · started 2013 · scored riskier than 47% of active trials completed
Trial of BI 6727 (Volasertib) Monotherapy and BI 6727 in Combination With Pemetrexed Compared to Pemetrexed Monotherapy in Advanced NSCLC NCT00824408 · started 2009 · scored riskier than 49% 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.