Oral Decitabine and Tetrahydrouridine as Epigenetic Priming for Pembrolizumab-Mediated Immune Checkpoint Blockade in Patients With Inoperable, or Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancers and Esophageal Carcinomas
Model scores of the 29,894 trials active now.
Model score 27% for any early termination, 17% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 30% of the time (96 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2021-10-26, after 2018-04-11 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 2021-10-26. 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: lung cancercell lungsmall cellnon smallnsclc
Phrases that lowered it: participantslineparticipantpatients whoreceived -
Sponsor's past termination rate: 18.2% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Maximum age: 99 (lowers risk) · Who can join
-
Drug's FAERS reports with a death: 30.8% (raises risk) · Drug's FDA history
-
Phase: 1/2 (raises risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 169 (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 81.8% (lowers risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Disease area, respiratory: Yes (raises risk) · Disease area
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Sponsor type: government (raises risk) · Sponsor's track record
-
Collaborators: 0 (raises risk) · Design
-
Design: sequential (raises risk) · Design
-
Disease area, dermatology: No (lowers 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
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 99 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 1163 (typical: 32)
- Sponsor's past termination rate
- 18.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 169 (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
- 10998 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4640 (typical: 412.5)
- Drug's FAERS reports marked serious
- 81.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 30.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, respiratory, digestive
- Drugs matched to FDA substances
- decitabine, pembrolizumab, tetrahydrouridine
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
- Rational EpigenetiC Immunotherapy for SEcond Line Therapy in Patients With NSCLC: PRECISE Trial NCT02664181 · started 2017 · scored riskier than 95% of active trials completed
- Study of Pembrolizumab and Chemotherapy With or Without Radiation in Small Cell Lung Cancer (SCLC) NCT02934503 · started 2017 · scored riskier than 88% of active trials terminated
- Phase II Study of Pembrolizumab After Curative Intent Treatment for Oligometastatic Non-Small Cell Lung Cancer NCT02316002 · started 2015 · scored riskier than 86% of active trials completed
- Ipilimumab and Nivolumab in Patients With Anti-PD-1-axis Therapy-resistant Advanced Non-small Cell Lung Cancer. NCT03262779 · started 2017 · scored riskier than 80% of active trials completed
- Neoadjuvant-Adjuvant Pembrolizumab in Resectable Advanced Basal Cell Carcinoma of H&N NCT04323202 · started 2020 · scored riskier than 62% 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.