Table 4.
Ongoing Clinical trials with targeted therapy.
| Clinical Trial | Study Design | Experiemental Drug | Type of BRAF incuded | Patient population | Status |
|---|---|---|---|---|---|
| PHAROS (84, 91) (NCT03915951) |
Open label, phase 2 multicenter | Encorafenib (BRAF inhibitor) with Binimetinib (MEK inhibitor) | BRAF V600 | Treatment naïve or post anti-PD1 treatment. | Active, Not recruting SNDA under FDA review |
| ENCO-BRAF (87) (NCT04526782) | Open label, phase 2, multicenter multicohort | Encorafenib with Binimetinib | BRAF V600 | Treatment naïve or pretreated. | Recruiting |
| OCEAN II (92) (NCT05195632) | Open label, phase 2, single arm | Encorafenib with Binimetinib | BRAF V600E | BRAF and MEK-inhibitor treatment naïve; First or second line | Recruiting |
| NCT03905148 (93) | Phase 1b, Open labe | Lifirafenib (RAF inhibitor) and Mirdametinib (MEK inhibitor) | All advanced tumors including BRAF mutant NSCLC | Advanced or metastatic tumor | Recruiting |
| LANDSCAPE 1011 (NCT04585815) (94) | Phase 1b/2 Open Label Umbrella | Sasanlimab (PD-1 antagonist monoclonal antibody) | Sub-Study A Phase Ib & 2: BRAF V600 | Advances NSCLC | Active, Not recruiting |
| NCT05065398 (95) | Phase 2, Open label, multicenter | HLX208 | BRAF V600 | Pretreated advanced BRAF NSCLC | Recruiting |
| NCT03284502 (96) | Phase 1, multicenter | HM95573 with Cobimetinib or Cetuximab | RAF mutant solid tumors Expansion cohort – class II and II BRAF |
Advanced RAF positive NSCLC | Recruiting |
| NCT02974725 (88) | Phase 1b, open label, multicenter | LXH254 with LTT462 or Trametinib or Ribociclib | All BRAF | Advanced or metastatic BRAF or KRAS mutant NSCLC | Active, not recruiting |
| ENHANCE (97) (NCT05275374) | Phase 1/2a | XP-102; XP-102 with Trametinib | BRAF V600 | Advanced BRAF malignant tumors – melanoma, colorectal, NSCLC, thyroid. | Not yet recruiting |
| B-FAST (82) (NCT03178552) | Phase 2/3, Open label, muticenter, multicohort | Cohort E: Atezolizumab, Cobimetinib, Vemurafenib | Cohort E: BRAF V600 | Unresectable, advanced or metastatic BRAF V600 mutation | Recruiting. (Enrollment for cohort E is complete) |
| NCT04892017 (98) | Phase 1/2, Open label, multicenter | DCC-3116 (monotherapy and in combination with trametinib, binimetinib, or sotorasib | All BRAF | Advanced or metastatic solid tumors with RAS/MAPK pathway mutation | Recruiting |
| NCT04913285 (99) | Phase 1/2, Open label, multicenter | KIN-2787 | All BRAF | Recruiting | |
| NCT03049618 (100) | Phase 2a | sEphB4-HAS (fusion protein) with Pembrolizumab (anti PD-1) | All BRAF | Locally advanced or metastatic non-small cell lung cancer progressed after at least 1 line of platinum-based chemotherapy | Active, Not recruiting |
| NCT04566393 (101) | Expanded access | Ulixertinib (BVD-523) (ERK1/2 inhibitor) | All BRAF | Advanced NSCLC in altered MAPK pathway | Available |
|
NCT04439279 (102) (MATCH-Subprotocol R) |
Phase 2 | Trametinib (MEK1/2 inhibitor) | BRAF fusion, non-V600 mutations | Patients With BRAF Fusions, or NonV600E or Non-V600K BRAF Mutations | Active, Not recruiting |
| NCT04249843 (103) | Phase 1a/1b | BGB 3245 (RAF Dimer inhibitor) | Class II and III BRAF mutations | Advanced or refractory tumore | Recruiting |
| NCT04488003 (104) | Phase 2, multicenter | Ulixertinib (BVD-523) | BRAF Non-V600 | Advanced Malignancies Harboring MEK or Atypical BRAF Alterations | Active, Not recruiting |
| NCT02428712 (105) | Phase 1/2a | FORE8394 | BRAF V600 or Non V600 | Advanced unresectable solid tumors | Active, Not recruiting |
| NCT03843775 (106) | Phase 1/2 | Binimetinib and Encorafenib | Non V600 BRAF | Metastatic or advanced-malignant tumors. | Active, Not recruiting |