A Study Evaluating Dalotuzumab (MK-0646) in Combination With Erlotinib for Participants With Non-Small Cell Lung Cancer (MK-0646-007)

NCT00654420 on ClinicalTrials.gov Phase 2 Merck Sharp & Dohme LLC (industry) Started 2008-03-19 Completed

Riskier than 59% of active trials

Model scores of the 29,894 trials active now.

Model score 18% for any early termination, 3% 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 2012-02-13, after 2008-03-19 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 2012-02-13. 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

Sponsor's past termination rate: 15.2% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: recurrentmetastaticchemotherapycancertherapy
Phrases that lowered it: participantparticipantsevaluateopen labelinvestigate
Disease area, cancer: Yes (raises risk) · Disease area
Drug's FAERS reports with a death: 28.3% (raises risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Design: parallel (raises risk) · Design
Sponsor's past trials: 369 (lowers risk) · Sponsor's track record
Number of arms: 4 (lowers risk) · Design
Maximum age: not given (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Blinding: none (raises risk) · Design
Drug's FAERS reports before start: 438 (lowers risk) · Drug's FDA history
Drug's FAERS reports marked serious: 98.4% (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: 4 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (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: 369 (typical: 32)
Sponsor's past termination rate: 15.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 263 (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: 438 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 233 (typical: 412.5)
Drug's FAERS reports marked serious: 98.4% (typical: 85.6%)
Drug's FAERS reports with a death: 28.3% (typical: 15.9%)

Disease area and drugs

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

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

Phase I Imaging Study Evaluating Dalotuzumab (MK0646) in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer (MK-0646-008) NCT00729742 · started 2009 · scored riskier than 94% of active trials completed
A Study of Dalotuzumab + MK-2206, Dalotuzumab + MK-0752, and Dalotuzumab + Ridaforolimus Combination Therapies in Participants With Advanced Cancer (MK-0646-027) NCT01243762 · started 2010 · scored riskier than 59% of active trials terminated
D-0316 First Time in Patients Ascending Dose Study NCT03452150 · started 2018 · scored riskier than 44% of active trials completed
D-0316 in Patients With EGFR Positive Non Small Cell Lung Cancer NCT03861156 · started 2019 · scored riskier than 41% of active trials completed
A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations NCT01897480 · started 2013 · scored riskier than 68% 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.