Non Small Cell Lung Cancer - APL-101 - MET amplification

Association details:

Biomarker:	MET amplification
Cancer:	Non Small Cell Lung Cancer
Drug:	bozitinib (APL-101) (c-MET inhibitor)
Direction:	Sensitive

Evidence:

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrials.gov

Title:

APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

Excerpt:

...- Cohort C / MET amplification basket tumor types excluding primary...

Trial ID:

SPARTA

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrialsregister.eu

Title:

A Single-arm, Multicenter, Phase Il clinical Study of Platinum-based Doublet Chemotherapy Sequential Vebreltinib as adjuvant Therapy for Patients With Resectable, stage IB-IIIB(N2) Non-Small Cell Lung Cancer with c-MET Exon 14 skipping mutation with or without other MET Alterations

Excerpt:

...Patients must harbor METex 14 skipping mutation(NGS reports from tissue/blood samples must be approved by organizations with CLIA or CAP certification ), with or without MET amplification/ MET protein overexpression....

Trial ID:

ChiCTR2400085552

More C2 evidence

Evidence Level:

Sensitive: C2 – Inclusion Criteria

Source:

clinicaltrialsregister.eu

Title:

Clinical trial to evaluate safety and effectiveness of APL-101 for the treatment of advanced c-Met expressing solid tumors, including NSCLC, and to find the best dose Klinikai vizsgálat az APL-101 biztonságosságának és hatásosságának értékelésére előrehaladott c-Met-et expresszáló szolid tumorok, ideértve az NSCLC-t (nem kissejtes tüdőrák), kezelésére és a legmegfelelőbb adagolás megtalálására

Excerpt:

...Cohort C: Basket Tumor Types (c-Met high-level amplifications)a.Any tumor type regardless of histology, including osimertinib relapsed/refractory NSCLC, excluding NSCLC EXON 14 skip mutation, that meets inclusion criteria c-Met high-level amplificationb.Unresectable or metastatic disease, refractory to standard therapies with no more than three prior lines of therapyc.Not received any c-Met inhibitor 4d. ...

Trial ID:

2019-001757-54

Evidence Level:

Sensitive: C3 – Early Trials

Source:

AACR-I 2020

Title:

Abstract CT127: A phase I study of cMET inhibitor bozitinib in patients with advanced NSCLC harboring cMET alterations

Published date:

04/27/2020

Excerpt:

Of the 37 enrolled patients, with a median age of 61: 8 had overexpression; 11 had exon 14 skipping; 8 had amplification and 10 patients had more than 1 type of MET alterations. Bozitinib was generally well-tolerated in all cohorts….ORR for patients with overexpression and amplification (N=6) was 50%. ORR for patients harboring both exon 14 skipping and amplification (N=4) was 100%.

DOI:

10.1158/1538-7445.AM2020-CT127

Trial ID:

NCT02896231