| General information |
| Database: | DB00811 |
| Objective: | In thisphase II study, patients with stage IIIB/IV non small cell lung cancer were randomly assigned (1:1:1) to receive LY293111 (200 mg twice daily [200 LY293111] or 600 mg twice daily [600 LY293111]) or placebo for 7 days, followed by concurrent cisplatin (75 mg/m2; day 1) and gemcitabine (1250 mg/m2; days 1 and 8), every 21 days.progression free survival, (PFS), with 75% potheyr to detect 33% improvement compared with placebo (5 months). |
| Authors: | J nne PA, et al |
| Title: | Randomized, doubleblind, phase II trial comparing gemcitabinecisplatin plus the LTB4 antagonist LY293111 versus gemcitabinecisplatin plus placebo in firstline non small cell lung cancer. |
| Journal: | J Thorac Oncol. |
| Year: | 2014 |
| PMID: | 24346102 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | LY293111
|
| Target: | Leukotriene B4 receptor 1
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | gemcitabinecisplatin + the LTB4 antagonist LY293111 |
| Study Type: | Randomized, doubleblind, phase II trial |
| Key Patients Feature: | Demographics were well balanced across treatment arms: 65% of the patients were men; median age was 62 years; 85% had stage IV disease; and patients had an Eastern Cooperative Oncology Group performance status of 0 (36%) or 1 (64%). |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | gemcitabinecisplatin plus the LTB4 antagonist LY293111 versus gemcitabinecisplatin plus placebo |
| Treatment Info: | patients were randomly assigned (1:1:1) to receive LY293111 (200 mg twice daily [200 LY293111] or 600 mg twice daily [600 LY293111]) or placebo for 7 days, followed by concurrent cisplatin (75 mg/m2; day 1) and gemcitabine (1250 mg/m2; days 1 and 8), every 21 days. |
| Primary End Point: | progression free survival, (PFS), with 75% potheyr to detect 33% improvement compared with placebo (5 months). |
| Secondary End Point: | NA |
| Patients Number: | 195 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 200 LY293111: 4.6 months [3.25.0]; 600 LY293111: 5.6 months [4.16.8]; placebo: 6.0 months [5.27.5] |
| Median OS A vs. C: | for 200 LY293111, 600 LY293111, and placebo were 10.8 (7.6-12.9) months, 10.7 (9.7-16.2) months, and 15.0 (12.7-19.1) months, respectively |
| Adverse Event(agent arm): | NA |
| Conclusions: | Median PFS (95% confidence interval) was not significantly different across treatment arms (200 LY293111 4.6 months [3.25.0]; 600 LY293111 5.6 months [4.16.8]; placebo 6.0 months [5.27.5]). LY293111 combined with gemcitabinecisplatin did not increase median PFS compared with placebo plus gemcitabinecisplatin in patients with non small cell lung cancer. |