Key trial design features include: Size: A 34-patient, single-arm study consisting of an initial group of 9 patients and a follow-on group of 25 subjects, and using a Simon's two-stage design
, a significance level of 5%, and a power of 80%, Comparison: A 19% objective response rate (ORR) for the combination versus an historical response of 3.7% ORR for single-agent Keytruda (Phase 2 KEYNOTE-158 study of pre-treated NET patients and unselected for PD-L1 status; NCT02628067), and Interim assessment: An efficacy assessment conducted 24 weeks after the initial treatment of the final patient in the initial group.
Cheshire West and Chester Council has commissioned Pave Aways on a two-stage design
and build contract.
Patient enrollment for TACTI-002 commenced in early 2019, with the first patient being dosed in March 2019.Under the Simon's two-stage design
, the initial cohort of first line NSCLC patients may be enlarged by a further 19 patients, if a pre-defined number of responses are observed.
The Phase II trial (BGBC008) follows a two-stage design
: it is an open label, multi-centre study of bemcentinib in combination with Keytruda in patients with previously treated advanced adenocarcinoma of the lung (non-small cell lung cancer, NSCLC) whose disease is progressing.
The Phase II trial, named BGBC007 follows a two-stage design
. It is an open label, multi-centre study of bemcentinib in combination with KEYTRUDA in patients with earlier treated, locally advanced and unresectable or metastatic triple negative breast cancer or triple negative inflammatory breast cancer.
Basically of two-stage design
, there's significant take-up, then a crisp wall against which the shooter may stage and squeeze through when a precise shot is required.
Because of the H-bomb's relatively complex two-stage design
, many experts thought it would be months, or perhaps years, before North Korea's scientists could master the necessary technology.
A Geissele Super SemiAutomatic trigger, a two-stage design
with light take-up, is located within an oversize, rounded guard.
Using the separation principle, the observer-based controller design via the two-stage design
 produces 
The included LED driver has a two-stage design
and is IP67 and CUL certified.