HER-2 positive + RAS wild-type

P2, N=50, Recruiting, University of Wisconsin, Madison | Active, not recruiting --> Recruiting | N=25 --> 50 | Trial completion date: Jul 2026 --> Jul 2028 | Trial primary completion date: Jul 2026 --> Jul 2028

P2, N=197, Recruiting, Gruppo Oncologico del Nord-Ovest | N=140 --> 197

Tucatinib plus trastuzumab was cost-effective if its price was the same as lapatinib for chemotherapy-refractory, HER2-positive, RAS wild-type unresectable or metastatic CRC from the perspective of healthcare payers in China. Our exploratory result could provide a reference for clinical application of tucatinib plus trastuzumab when they are correctly interpreted.

P2, N=37, Recruiting, Memorial Sloan Kettering Cancer Center | Trial primary completion date: Jun 2026 --> Jul 2027

The value of HER2-targeted treatments in patients with HER2+ mCRC has been evidenced by clinical trials and meta-analyses, with strong evidence from MOUNTAINEER and DESTINY-CRC01 which supports the use of tucatinib + trastuzumab or trastuzumab deruxtecan, respectively, among this patient population. Strong evidence and clinical guidelines support the value of HER2-targeted treatment among patients with HER2+ mCRC. There is a need for increased awareness and earlier uptake of HER2 testing among patients with mCRC to broaden treatment options and optimise outcomes for this patient population.

P2, N=38, Not yet recruiting, Emory University

P2, N=37, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Dec 2026 --> Jul 2030 | Trial primary completion date: Dec 2026 --> Jun 2026

P2, N=37, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026

P2, N=90, Not yet recruiting, The First Affiliated Hospital of Henan University of Chinese Medicine; The First Affiliated Hospital of Henan University of Chinese Medicine

P=N/A, N=105, Recruiting, AstraZeneca | N=384 --> 105

Dual HER2-targeted therapy combined with chemotherapy is a promising strategy for HER2-positive mCRC patients with good performance status. This approach warrants validation in large-scale clinical trials to confirm its efficacy.

Pyrotinib plus trastuzumab demonstrates clinically meaningful efficacy and a manageable safety profile in heavily pretreated HER2-positive metastatic colorectal cancer. These findings support advancing this regimen as a potential alternative in refractory HER2-positive mCRC, particularly in the RAS/BRAF wild-type subgroup.