18 and older, any sex, with Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])Primary· Baseline to 10 months
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions
Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2Secondary· Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime
Pharmacokinetics(PK): Maximum Concentration of Prexasertib. The same dose was administered to Cohort 1 and Cohort 2 and were combined for analysis.
Cycle 1
Group
Value
95% CI
105 mg/m^2 Prexasertib
722
± 64
Cycle 3
Group
Value
95% CI
105 mg/m^2 Prexasertib
735
± 71
Cycle 5
Group
Value
95% CI
105 mg/m^2 Prexasertib
732
± 69
Cycle 7
Group
Value
95% CI
105 mg/m^2 Prexasertib
1230
± 22
Pharmacokinetics(PK): Maximum Concentration of Prexasertib Cohort 3 (40 mg/m^2, Protocol Addenda)Secondary· Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime
Pharmacokinetics(PK): Maximum Concentration of Prexasertib
Group
Value
95% CI
40 mg/m2 Prexasertib Exploratory Addendum
227
± 68
Pharmacokinetics: Area Under the Concentration Curve of PrexasertibSecondary· Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime
Pharmacokinetics: Area Under the Concentration Curve of Prexasertib
Disease Control Rate: Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD)Secondary· Baseline through Disease Progression or Death from Any Cause to 28 months
Disease control rate (DCR) is defined as the percentage of participants achieving a best overall response of CR, PR, or SD as determined by RECIST 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to \<10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters; SD is defined as neither sufficient shrinking to qualify as PR nor sufficient increase to qualify for PD.
Progression-Free Survival (PFS)Secondary· Baseline to Disease Progression or Death (up to 9 months)
PFS defined as the from randomization date to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progre
Duration of Response (DoR)Secondary· Date of CR or PR to Date of Disease Progression or Death Due to Any Cause up to 9 months
DoR the time from the date of an objective response until Progressive Disease (PD): was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Overall Survival (OS)Secondary· Baseline up to 28 months
OS defined as from randomization date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
Change From Baseline in Lung Cancer Symptom Scale Score (LCSS)Secondary· Baseline up to 9 months
LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. The LCSS total score was defined as the mean of the 9 items of the scale, each scored between 0 (for best outcome) to 100 (for worst outcome).
Group
Value
95% CI
Cohort 1 Prexasertib (Platinum Sensitive Disease)
-2.8
± 12.3
Cohort 2 Prexasertib (Platinum Resistant Disease)
-4.0
± 10.2
Change From Baseline on the Average Symptom Burden Index (ASBI)Secondary· Baseline up to 9 months
ABSI was the mean score for the six major lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis and pain), each scored between 0 (for best outcome) to 100 (for worst outcome).
Group
Value
95% CI
Cohort 1 Prexasertib (Platinum Sensitive Disease)
-3.0
± 11.9
Cohort 2 Prexasertib (Platinum Resistant Disease)
-4.4
± 11.1
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 28 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to evaluate the safety and efficacy of prexasertib when given to participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will evaluate how the body processes the drug and how the drug affects the body. The study will also evaluate the association between tumor response and the participant's perceived quality of life.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04095221 — A Study of the Drugs Prexasertib, Irinotecan, and Temozolomide in People With Desmoplastic Small Round Cell Tumor and Rh
· Phase 1, PHASE2
· completed
NCT04023669 — Evaluation of LY2606368 Therapy in Combination With Cyclophosphamide or Gemcitabine for Children and Adolescents With Re
· Phase 1
· completed
NCT03735446 — Prexasertib in Combination With MEC in Relapsed/Refractory AML and High Risk MDS - a Phase I Trial
· Phase 1
· terminated
NCT03495323 — A Study of Prexasertib (LY2606368), CHK1 Inhibitor, and LY3300054, PD-L1 Inhibitor, in Patients With Advanced Solid Tumo
· Phase 1
· completed
NCT03414047 — A Study of Prexasertib (LY2606368) in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 17 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02735980.