Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC
Model scores of the 29,894 trials active now.
Model score 28% for any early termination, 8% 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
Completed on 2020-01-22, after 2013-09-30 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 2020-01-22. 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: nsclclung cancersmall cellcell lungnon small
Phrases that lowered it: and safetysafety ofopen labelefficacy andthe efficacy -
Sponsor's past termination rate: 15.9% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Drug's FAERS reports with a death: 32.6% (raises risk) · Drug's FDA history
-
Minimum age: 18 (raises risk) · Who can join
-
Design: single group (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Keywords listed: 15 (raises risk) · Design
-
Sponsor's past trials: 1293 (raises risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 224 (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Collaborators: 1 (raises risk) · Design
-
Number of arms: 1 (raises risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Drug's FAERS reports before start: 1618 (raises risk) · Drug's FDA history
-
Drug's FAERS reports in the prior 12 months: 985 (raises 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
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 15 (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
- 1293 (typical: 32)
- Sponsor's past termination rate
- 15.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 224 (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
- 1618 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 985 (typical: 412.5)
- Drug's FAERS reports marked serious
- 64.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 32.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, respiratory
- Drugs matched to FDA substances
- crizotinib
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 Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients NCT01639001 · started 2012 · scored riskier than 96% of active trials completed
- A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung NCT01154140 · started 2011 · scored riskier than 90% of active trials completed
- Study of Crizotinib for ROS1 and MET Activated Lung Cancer NCT04084717 · started 2019 · scored riskier than 99% of active trials completed
- A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) NCT01871805 · started 2013 · scored riskier than 64% of active trials completed
- Phase II Single Arm Study of AZD9291 to Treat NSCLC Patients in Asia Pacific NCT02442349 · started 2015 · scored riskier than 23% 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.