TIGER-3: Open Label, Multicenter Study of Rociletinib (CO-1686) Mono Therapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR NSCLC Who Have Failed at Least One Previous EGFR-Directed TKI and Platinum-doublet Chemotherapy
Model scores of the 29,894 trials active now.
Model score 27% for any early termination, 5% 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 (927 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2018-03-29, after 2015-02-28 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 2018-03-29. 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: nsclcsmall cellcell lungnon smalllung cancer
Phrases that lowered it: patientsdays beforeopen labelinvestigatorpatient -
Sponsor's past termination rate: 25% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Drug's FAERS reports with a death: 26.2% (raises risk) · Drug's FDA history
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Drug's FAERS reports marked serious: 96.9% (raises risk) · Drug's FDA history
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
-
Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
-
Keywords listed: 16 (raises risk) · Design
-
Number of arms: 3 (lowers risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Collaborators: 0 (raises risk) · Design
-
Disease area, respiratory: Yes (raises risk) · Disease area
-
Drug's FAERS reports in the prior 12 months: 8709 (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
- 3 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 16 (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
- 4 (typical: 32)
- Sponsor's past termination rate
- 25% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (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
- 49170 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 8709 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 26.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, respiratory
- Drugs matched to FDA substances
- docetaxel, gemcitabine, paclitaxel, pemetrexed, rociletinib
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
- TIGER-1: Safety and Efficacy Study of Rociletinib (CO-1686) or Erlotinib in Patients With EGFR-mutant/Metastatic NSCLC Who Have Not Had Any Previous EGFR Directed Therapy NCT02186301 · started 2014 · scored riskier than 89% of active trials terminated
- Multicenter Study of Rociletinib Administered to Patients With Previously Treated Mutant EGFR Non-small Cell Lung Cancer NCT02147990 · started 2014 · scored riskier than 88% of active trials terminated
- Osimertinib (AZD9291) in First-line Locally Advanced or Metastatic NSCLC Patients With EGFR and EGFR T790M NCT02841579 · started 2016 · scored riskier than 79% of active trials completed
- Erlotinib in Combination With Cetuximab NCT00895362 · started 2009 · scored riskier than 66% of active trials completed
- Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients NCT01526928 · started 2012 · scored riskier than 92% 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.