A Study of Tarceva (Erlotinib) in Sequential Combination With Gemcitabine as First Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer
Model scores of the 29,894 trials active now.
Model score 15% 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 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
Terminated on 2011-09-30, after 2009-06-30 start.
Reason given by the sponsor: “enrollment”
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 2011-09-30. 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
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 11.8% (raises risk) · Sponsor's track record
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: gemcitabinecellcanceradvancedchemotherapy
Phrases that lowered it: and safetyefficacy andelderlythe efficacycompare -
Has a data monitoring committee: not given (lowers risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Phase: 2 (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 193 (lowers risk) · Sponsor's track record
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 23.1% (raises risk) · Drug's FDA history
-
Drug's FAERS reports marked serious: 95.8% (raises risk) · Drug's FDA history
-
Design: parallel (raises risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 2 (raises risk) · Design
-
Sponsor's past trials: 221 (lowers risk) · Sponsor's track record
-
Disease area, respiratory: Yes (raises risk) · Disease area
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
- 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
- 221 (typical: 32)
- Sponsor's past termination rate
- 11.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 193 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 4057 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 950 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 23.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, respiratory
- Drugs matched to FDA substances
- erlotinib, gemcitabine
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
- A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer NCT00701558 · started 2008 · scored riskier than 21% of active trials completed
- A Study of Tarceva (Erlotinib) or Placebo in Combination With Platinum-Based Therapy as First Line Treatment in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer NCT00883779 · started 2009 · scored riskier than 29% of active trials completed
- A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Having Received Tarceva Monotherapy. NCT00773383 · started 2008 · scored riskier than 46% of active trials terminated
- A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations NCT01342965 · started 2011 · scored riskier than 31% of active trials completed
- A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC). NCT00760929 · started 2008 · scored riskier than 60% 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.