| General information |
| Database: | DB00066 |
| Objective: | In preclinical models, the EGFR inhibitor AZD9291 has been shown to be effective against both EGFR tyrosine kinase inhibitorsensitizing and T790M resistance mutations |
| Authors: | J nne PA, et al |
| Title: | AZD9291 in EGFR inhibitorresistant non small cell lung cancer. |
| Journal: | N Engl J Med. |
| Year: | 2015 |
| PMID: | 25923549 |
| Trial Design |
| Clinical Trial Id: | NCT01802632 |
| Agent: | AZD9291
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase I/II:included doseescalation cohorts and doseexpansion cohorts |
| Key Patients Feature: | patients with advanced lung cancer who had radiologically documented disease progression after previous treatment with EGFR TKI |
| Biomarker: | EGFR T790M status |
| Biomark Analysis: | Among 127 patients with centrally confirmed EGFR T790M who could be evaluated for response, the response rate was 61% (95% CI, 52 to 70). In contrast, among 61 patients without centrally detectable EGFR T790M who could be evaluated for response, the response rate was 21% (95% CI, 12 to 34). The median progression free survival was 9.6 months (95% CI, 8.3 to not reached) in EGFR T790Mpositive patients and 2.8 months (95% CI, 2.1 to 4.3) in EGFR T790Mnegative patients. |
| Control Group Info: | single arm |
| Treatment Info: | they administered AZD9291 at doses of 20 to 240 mg once daily in patients with advanced lung cancer who had radiologically documented disease progression after previous treatment with EGFR tyrosine kinase inhibitors. |
| Primary End Point: | safety, pharmacokinetics, and efficacy |
| Secondary End Point: | NA |
| Patients Number: | 253 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | (ORR 51%, DCR 84%)ORR P vs N:61% vs 21% |
| Disease Control Rate: | 95% (121 of the 127patients; 95% CI, 90 to 98) |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 9.6 vs 2.8(P vs N) |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | hyperglycaemia(2%), rash (40%), paronychia (17%), and stomatitis (12%) |
| Conclusions: | AZD9291 was highly active in patients with lung cancer with the EGFR T790M mutation who had had disease progression during prior therapy with EGFR tyrosine kinase inhibitors |