Table 2.
Ongoing phase 2 and 3 trials targeting HER2-positive gastroesophageal cancer
| Trials/ID | Treatments | Phase | Patients | Line of therapy | Primary endpoints | Estimated completion date | Region |
|---|---|---|---|---|---|---|---|
| KEYNOTE-811/NCT03615326 | Pembrolizumab/placebo + trastuzumab + chemotherapy | 3 | HER2-positive advanced gastric cancer or GEJ adenocarcinoma | 1st | PFS, OS | June 2023 | Global |
| NCT02954536 [60] | Pembrolizumab, trastuzumab, capecitabine/cisplatin | 2 | HER2-positive metastatic gastroesophageal cancer | 1st | PFS | November 2019 | USA |
| NCT02901301 | Pembrolizumab + trastuzumab + capecitabine + cisplatin | 1b/2 | HER2-positive gastric cancer | 1st | RP2D, responses | March 2019 | Korea |
| NCT01522768 | Afatinib + paclitaxel | 2 | Trastuzumab-refractory HER2-positive metastatic or recurrent GEA | > 1 | Responses | February 2020 | USA |
| NCT02501603 | Afatinib + paclitaxel | 2 | Advanced/metastatic gastric or GEJ cancer including HER2-positive refractory to trastuzumab | 2nd | PFS | December 2018 | Korea |
| DESTINY-Gastric01/NCT03329690 | Trastuzumab deruxtecan (DS-8201a) vs physician’s choice | 2 | HER2-positive advanced gastric or GEJ adenocarcinoma | > 2 | Responses | December 2019 | Japan |
| INTEGA/NCT03409848 | Trastuzumab + nivolumab + ipilimumab or nivolumab + FOLFOX + trastuzumab | 2 | HER2-positive locally advanced or metastatic GEA | 1st | OS | October 2021 | Germany |
| NCT02689284 [64] | Margetuximab + pembrolizumab | 1b/2 | Relapsed/refractory advanced HER2-positive GEJ or gastric cancer | >1 | MTD, responses | December 2017 | Global |
| NCT02713984 | HER2-targeted CAR T cells | 1/2 | Relapsed or refractory HER2-positive cancer | >1 | MTD | September 2018 | China |
| NCT03130790 | Varlitinib/placebo + mFOLFOX6 | 2/3 | Co-expression of HER1 and HER2 advanced or metastatic gastric or GEJ adenocarcinoma | 1st | Responses, OS | December 2018 | Asia |
| SUMMIT/NCT01953926 [65] | Neratinib monotherapy | 2 | HER2 mutated cancers excluding colon cancer, lung cancer, breast cancer, and bladder cancer, HER4 mutated cancer | Any | Responses | March 2022 | USA |
| INNOVATION/NCT02205047 | Neoadjuvant trastuzumab or trastuzumab + pertuzumab with chemotherapy | 2 | HER2-positive, resectable gastric cancer | 1st | Major pathological response | September 2020 | Global |