Table 2.
Ongoing Clinical Trials of Tecemotide
| Study Identifier Indication | Status | Description | Patients Planned | Reference |
|---|---|---|---|---|
|
NCT00960115 EMR 63325–009 Unresectable stage III NSCLC |
Closed to enrollment | Combined Phase I/II study in Japanese subjects with stage III unresectable NSCLC following primary chemotherapy. | 205 | 69 |
|
NCT00828009 EMR 63325–600 (ECOG 6508) Unresectable stage III NSCLC |
Open to enrollment* | Phase II study of tecemotide and bevacizumab in unresectable stage IIIA and IIIB NSCLC after definitive CRT. | 55 | 79 |
|
NCT01015443 EMR 63325–012 (INSPIRE) Unresectable stage III NSCLC |
Open to enrollment* | Phase III clinical trial of tecemotide in Asian subjects with stage III, unresectable, NSCLC who have demonstrated either stable disease or objective response following primary CRT. | 420 | 25,36 |
|
NCT02049151 EMR 63325–021 (START2) Unresectable stage III NSCLC |
Open to enrollment* | A multicenter randomized double-blind placebo-controlled Phase III trial of tecemotide vs. placebo in patients with completed concurrent CRT for unresectable stage III NSCLC. | 1002 | 73 |
|
NCT01423760 EMR 63325–011 Tumor type as per feeder trial |
Enrollment on invitation | Open label trial to collect long-term data on subjects who have received tecemotide in previous clinical trials. | 262 | — |
|
NCT01507103 EMR 63325–013 (SPRINT) Rectal cancer |
Closed to enrollment* | Multi-center, randomized, open-label, mechanistic trial of the biological effects of tecemotide in rectal cancer subjects undergoing neoadjuvant CRT. | 124 | 76 |
|
NCT01496131 EMR 63325–015 Prostate cancer |
Open to enrollment* | A randomized Phase II study of tecemotide in combination with standard ADT and RTX for newly diagnosed, high-risk prostate cancer. | 48 | 78 |
|
NCT01462513 EMR 63325–602 (LICC) Colorectal cancer |
Open to enrollment* | Multicenter, multinational, randomized (2:1), double-blind, placebo-controlled Phase II trial in colorectal carcinoma after curative resection of hepatic metastases. | 159 | 74,75 |
| EMR 63325–603 (ABCSG 34) Breast cancer | Open to enrollment* | Multicenter, randomized (1:1), open label, 2-arm trial in the pre-operative treatment of women with primary breast cancer. | 400 | 77 |
*as of June 2014.