TAS3351 / Otsuka, Taiho - LARVOL DELTA

A Study of TAS3351 in NSCLC Patients With EGFRmt (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Taiho Oncology, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TAS3351 in NSCLC Patients With EGFRmt (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Taiho Oncology, Inc.

Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TAS3351 in NSCLC Patients With EGFRmt (clinicaltrials.gov) - P1 | N=18 | Terminated | Sponsor: Taiho Oncology, Inc. | Phase classification: P1/2 ➔ P1

First-in-human • Phase classification • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

TAS3351 is a brain penetrable EGFR-TKI that overcomes T790M and C797S resistant mutations. (PubMed, Commun Med (Lond)) - "These findings indicate that TAS3351 is a promising therapeutic candidate for patients with NSCLC whose tumors have relapsed or are refractory to treatment due to the C797S and T790M mutations, and the brain metastases."

Journal • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TAS3351 in NSCLC Patients With EGFRmt (clinicaltrials.gov) - P1/2 | N=18 | Terminated | Sponsor: Taiho Oncology, Inc. | N=200 ➔ 18

Enrollment change • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TAS3351 in NSCLC Patients With EGFRmt (clinicaltrials.gov) - P1/2 | N=200 | Terminated | Sponsor: Taiho Oncology, Inc. | Trial completion date: Dec 2027 ➔ Mar 2025 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2027 ➔ Mar 2025; Strategic decision, not based on safety concerns

Trial completion date • Trial primary completion date • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

TAS3351, a fourth-generation brain-penetrating EGFR inhibitor designed to target common EGFR mutations, including those with or without T790M and C797S resistance mutations (EORTC-NCI-AACR 2024) - P1/2 | "Such patients harboring these common EGFR mutations have been shown to benefit from EGFR-tyrosine kinase inhibitors (TKIs), including osimertinib, a third-generation irreversible EGFR-TKI. TAS3351 is a brain-penetrating next-generation EGFR-TKI capable of overcoming the drug resistance mediated by T790M and C797S mutations in NSCLC with common EGFR mutations. A phase I/II study (NCT05765734) is currently underway to evaluate TAS3351 in patients with advanced or metastatic NSCLC who have acquired the C797S EGFR mutation."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of TAS3351 in NSCLC Patients With EGFRmt (clinicaltrials.gov) - P1/2 | N=200 | Not yet recruiting | Sponsor: Taiho Oncology, Inc.

Metastases • New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

TAS3351 is a 4th-generation EGFR-TKI overcoming T790M and C797S-mediated resistance in NSCLC with EGFR common mutations (AACR 2022) - "Background: Common mutations (exon 19 deletion; ex19del or L858R point mutation; L858R) of the epidermal growth factor receptor (EGFR) are found in patients with non-small cell lung cancer (NSCLC) and are sensitive to EGFR-tyrosine kinase inhibitors (TKIs), including osimertinib, a third-generation, irreversible EGFR-TKI...While first-generation, reversible EGFR-TKIs (gefitinib and erlotinib) might be effective for patients with C797S mutation, the T790M mutation is reported to emerge in almost half of patients with EGFR common mutations during treatment with first-generation EGFR-TKIs... TAS3351 is a fourth-generation EGFR-TKI overcoming T790M and C797S-mediated resistance in NSCLC with common mutations. The present results support the clinical development of TAS3351 as monotherapy in NSCLC patients with EGFR mutations harboring C797S and/or T790M EGFR-TKI resistance mutations."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR