18 and older, any sex, with Non-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.
Objective Response Rate (ORR)Primary· From date of first dose of study drug until, or up to the date of data cutoff (07 Apr 2011)
ORR was defined as the percentage of participants whose best overall response (BOR) was either a confirmed complete response (CR) or a partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for target lesions assessed by computed tomography (CT) or magnetic resonance imaging (MRI) and based on investigator assessment. CRs and PRs had to be confirmed by a repeat assessment of response (CR or PR) separated by at least 4 weeks (28 days). CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to
Group
Value
95% CI
Eribulin Mesylate Plus Erlotinib, 21 Day Regimen
12.7
5.6 – 23.5
Eribulin Mesylate Plus Erlotinib, 28 Day Regimen
16.7
8.3 – 28.5
Duration of Response (DOR)Secondary· From date of first document CR or PR (whichever was recorded first) until first documentation of disease progression or death due to any cause, or up to data cutoff (31 May 2013) up to 3.25 years
DOR was assessed for participants with a BOR of CR or PR, and was defined as the time from first documented evidence of CR or PR (whichever status was recorded first) until the first documented sign of disease progression or death (due to any cause), whichever was first. DOR was defined for participants with a confirmed CR or PR. For participants in the subset of responders who did not progress or die, duration of response was censored. DOR was analyzed using the Kaplan-Meier method.
Group
Value
95% CI
Eribulin Mesylate Plus Erlotinib, 21 Day Regimen
9.4
2.7 – NA
Eribulin Mesylate Plus Erlotinib, 28 Day Regimen
9.7
5.6 – NA
Progression-Free Survival (PFS)Secondary· From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first), or up to data cutoff (31 May 2013) up to 3.25 years
PFS was measured as the time from the date of first administration of study treatment until the first documentation of disease progression or death (due to any cause), whichever occurred first, as determined by investigator assessment based on RECIST v1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. For participants who did not have an event (i.e. those who ha
Group
Value
95% CI
Eribulin Mesylate Plus Erlotinib, 21 Day Regimen
3.5
1.9 – 4.7
Eribulin Mesylate Plus Erlotinib, 28 Day Regimen
3.8
3.3 – 5.5
Disease Control Rate (DCR)Secondary· From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (31 May 2013), up to approximately 3.25 years
DCR was defined as the percentage of participants who had a BOR of CR or PR, or stable disease (SD; duration of SD lasted for at least 7 weeks). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD was to be greater than or equal to 7 weeks (49 days). A participant's tumor assessment had to be at least 7 weeks following the randomization date to be consider SD. DCR and the corresponding exact Clopper-Pearson 95% CI were computed by treatment regimen. (CR + PR + SD)
Group
Value
95% CI
Eribulin Mesylate Plus Erlotinib, 21 Day Regimen
47.6
34.9 – 60.6
Eribulin Mesylate Plus Erlotinib, 28 Day Regimen
63.3
49.9 – 75.4
Overall Survival (OS)Secondary· From date of first dose of study drug until date of death from any cause or up to data cutoff (31 May 2013), up to approximately 3.25 years
OS was defined as the length of time in months from the date of first administration of study drug until the date of death from any cause, and was based on the data cutoff date. In the absence of confirmation of death, participants were censored either at the date that the participant was last known to be alive or the date of study cutoff, whichever came first. OS and the corresponding 2-sided 95% CI was analyzed using the Kaplan-Meier method.
Group
Value
95% CI
Eribulin Mesylate Plus Erlotinib, 21 Day Regimen
7.6
6.3 – 11.0
Eribulin Mesylate Plus Erlotinib, 28 Day Regimen
8.5
6.2 – 13.1
Adverse events — posted to ClinicalTrials.gov
Time frame: From date of administration of first dose up to 30 days after the last dose, or up to approximately 6 years 11 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase 2, multicenter, randomized study of two different dose regimens of eribulin mesylate in combination with intermittent erlotinib in patients with previously treated, advanced non-small cell lung cancer.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 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 Eisai Inc.
Last refreshed: 22 June 2023
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/NCT01104155.