Table 2.
Ongoing clinical studies for third-generation tyrosine kinase inhibitors. edited from [68]
| Phase | Primary endpoint | Status | Thr790Met status | Key features | ||
|---|---|---|---|---|---|---|
| AZD9291 | ||||||
| AURA-2 (ClinicalTrials. gov, number NCT02094261) | 2 | Objective response rate | Ongoing but not recruiting | Positive | Failed EGFR-TKI; EGFR mutant | |
| AURA-3 (ClinicalTrials. gov, number NCT02151981) | 3 | PFS | Recruiting | Positive | Failed first-line EGFR -TKI; EGFR mutant;
standard group: platinum-based doublet chemotherapy |
|
| FLAURA (ClinicalTrials. gov, number NCT02296125) | 3 | PFS | Recruiting | Positive/negative | First-line; EGFR mutant;
standard group: gefitinib/erlotinib |
|
| ClinicalTrials.gov, number NCT02143466 | 1 | Safety and tolerability | Recruiting | Positive/negative | Failed EGFR-TKI; EGFR mutant;
AZD9291 in combination with either MEDI4736 or AZD6094 or selumetinib |
|
| Rociletinib | ||||||
| TIGER-1 (ClinicalTrials. gov, number NCT02186301) | 2 | PFS | Recruiting | Positive/negative | First-line, randomised; EGFR mutant;
standard group: erlotinib |
|
| TIGER-2 (ClinicalTrials. gov, number NCT02147990) | 2 | ORR | Recruiting | Positive | Single group; EGFR mutant;
failed first-line EGFR-TKI |
|
| TIGER-3 (ClinicalTrials. gov,
number NCT02322281) |
3 | PFS | Not yet recruiting | Positive/negative | Failed EGFR-TKI and platinum doublet chemotherapy;
EGFR mutant; standard group: single-agent chemotherapy |
|
| HM61713 | ||||||
| ClinicalTrials.gov Identifier: NCT02444819 | 2 | overall response rate | Recruiting | Positive | First-line;
EGFR Mutation |
|
| ClinicalTrials.gov Identifier: NCT02485652 | 2 | ORR | Recruiting | Positive | Failed EGFR-TKI; EGFR mutant | |
| ClinicalTrials.gov Identifier: NCT01894399 | 1 | Plasma/Urine PK parameters | Not yet recruiting | No | Healthy Korean, Japanese and Caucasian Randomized | |
| ClinicalTrials.gov Identifier: NCT01588145 | 1 | Safety and tolerability | Recruiting | Positive | advanced NSCLC； EGFR mutant | |
| EGF816 | ||||||
| ClinicalTrials.gov Identifier: NCT02323126 | 2 | PFS | Recruiting | Positive | Adult Patients; EGFR Mutated
Combination With Nivolumab |
|
| ClinicalTrials.gov Identifier: NCT02335944 | 1/2 | DLT; ORR | Recruiting | Positive | NSCLC;
EGFR mutant in Combination With INC280 |
|
| ClinicalTrials.gov Identifier: NCT02108964 | 1/2 | DLT; ORR | Recruiting | Positive | Adult Patients With EGFR mut Solid Malignancies | |
| ASP8273 | ||||||
| ClinicalTrials.gov Identifier: NCT02500927 | 2 | adverse events | Recruiting | Positive | EGFR-TKI naïve Patients； EGFR mutant | |
| ClinicalTrials.gov Identifier: NCT02192697 | 1/2 | Safety and tolerability | Active, not recruiting | Positive | NSCLC;
EGFR mutant |
|
| ClinicalTrials.gov Identifier: NCT02113813 | 1 | Safety and tolerability | Recruiting | Positive | NSCLC;
EGFR mutant |
|
PFS=progression free survival; TKI=tyrosine kinase inhibitor; ORR=objective response rate; DLT=dose limiting toxicity