| General information |
| Database: | DB00736 |
| Objective: | Thisphase II, openlabel study investigated intercalated combinations of eribulin and erlotinib in unselected patients with advanced non small cell lung cancer previously treated with platinumbased chemotherapies. |
| Authors: | Mok TS, et al |
| Title: | Randomizedphase II study of two intercalated combinations of eribulin mesylate and erlotinib in patients with previously treated advanced non small cell lung cancer. |
| Journal: | Ann Oncol. |
| Year: | 2014 |
| PMID: | 24827127 |
| Trial Design |
| Clinical Trial Id: | NCT01104155 |
| Agent: | eribulin mesylate and erlotinib
|
| Target: | NA
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | eribulin mesylate+erlotinib |
| Study Type: | Randomizedphase II study |
| Key Patients Feature: | 18 years or older; histologically confirmed non small cell lung cancer with measurable disease; more than and equal to 1 prior platinumbased doublet chemotherapy for recurrent/advanced non small cell lung cancer; disease progression during or after last anticancer therapy; Eastern Cooperative Oncology Group performance status less than and equal to 2; adequate bone marrow, liver, and renal function. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | eribulin mesylate 2.0 mg/m(2) on day 1 with erlotinib 150 mg on days 216 (21day regimen) or eribulin mesylate 1.4 mg/m(2) on days 1 and 8 with erlotinib 150 mg on days 1528 (28day regimen). |
| Treatment Info: | Eligible patients were randomized to eribulin mesylate 2.0 mg/m(2) on day 1 with erlotinib 150 mg on days 216 (21day regimen) or eribulin mesylate 1.4 mg/m(2) on days 1 and 8 with erlotinib 150 mg on days 1528 (28day regimen). |
| Primary End Point: | ORR. |
| Secondary End Point: | PFS, duration of response (DOR), disease control rate (DCR), and OS. Clinical benefit rate (CBR) was an exploratory efficacy end point. Safety, pharmacokinetic (PK), and exploratory biomarker analyses were also carried out. |
| Patients Number: | 123 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 13% [95% confidence interval (CI) 6%-24%] and 17% (95% CI 8%-29%) for the 21 and 28day regimens |
| Disease Control Rate: | 48% (95% CI 35%-61%) and 63% (95% CI 50%-75%) for the 21 and 28day regimens |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.5 and 3.8 months for the 21 and 28day regimen |
| Median OS A vs. C: | 7.6 and 8.5 months for the 21 and 28day regimen |
| Adverse Event(agent arm): | With both regimens, all patients reported AEs and the incidences of grade more than and equal to 3 AEs were 84% for the 21day regimen and 80% for the 28day regimen. The total number of deaths considered to be treatmentrelated was 5 (21day: febrile neutropenia, acute respiratory failure, and pneumonia; 28day: febrile neutropenia and pneumonia). Other AEs were mostly diseaserelated. The incidences of AEs (all grades) are summarized in supplementary Table S2, available at Annals of Oncology online. Most common grade more than and equal to 3 AEs for the 21 and 28day regimens included neutropenia (56% versus 48%), asthenia/fatigue (13% versus 12%), and dyspnoea (10% for both regimens). Febrile neutropenia occurred in more patients on the 21day regimen than the 28day regimen (17% versus 5%). More patients on the 21day regimen required dose reductions due to AEs (40% versus 27% for the 28day regimen), and the incidence of SAEs also appeared to be higher (60% versus 45%), including a higher incidence of SAEs requiring/prolonging hospitalization (59% versus 35%). More patients on the 21day regimen experienced AEs leading to study drug withdrawal (24% versus 10% for the 28day regimen). A total of 15 patients had AEs resulting in death. |
| Conclusions: | Intercalated combination of eribulin and erlotinib demonstrated modest activity and the addition of erlotinib did not appear to improve treatment outcome in an unselected population. The 28day regimen is suitable for further investigation. Clinicaltrials.gov identifier NCT01104155. |