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Association details:
Biomarker:ALK rearrangement
Cancer:Solid Tumor
Drug:Alecensa (alectinib) (ALK inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Standard dose alectinib versus Therapeutic Drug Monitoring guided alectinib dosing

Excerpt:
...Documented ALK rearrangement based on an EMA approved test6. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Expanded Access Study of Alectinib for Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy

Excerpt:
...- Documented ALK rearrangement as assessed by approved fluorescence in situ hybridization (FISH) test, using the Vysis ALK Break Apart FISH Probe Kit or the Ventana immunohistochemistry (IHC) test...
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements

Excerpt:
...Confirmation of positive ALK rearrangement per local standard of care testing....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels

Excerpt:
...- Documented ALK rearrangement based on an EMA approved test...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB)

Excerpt:
...ALK-rearrangement 3....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Study of Alectinib in RET-rearranged Non-small Cell Lung Cancer or RET-mutated Thyroid Cancer

Excerpt:
...- Phase 1: Subjects must have a histologically or cytologically confirmed diagnosis of metastatic (AJCC Stage IV) NSCLC that carries an ALK rearrangement with CNS metastases, as determined by FISH, RT-PCR, immunohistochemistry (IHC), or NGS via a CLIA-certified LDT....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Study of the Efficacy and Safety of Alectinib in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer

Excerpt:
...- Having contributive biopsy performed on fresh tissue (FFPE blocks required) taken after progression on previous therapy showing presence of anaplastic lymphoma kinase (ALK) rearrangement, assessed by immunohistochemistry (IHC) and confirmed by fluorescence in situ hybridization (FISH)...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment

Excerpt:
...- Documented ALK rearrangement based on Food and Drug Administration (FDA)-approved test...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)

Excerpt:
...- ALK-rearrangement confirmed by the Food and Drug Administration (FDA) approved test...
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Impact of ALK Inhibitors in Patients With ALK-Rearranged Nonlung Solid Tumors

Published date:
05/03/2021
Excerpt:
...the potential benefit of ALK-TKIs, especially alectinib, in patients with ALK-rearranged nonlung solid tumors.
DOI:
10.1200/PO.20.00383