Msac application 1173


Patients Prior tests



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Patients

Prior tests

Intervention

Comparator

Reference Standard

(for diagnostic tests)

Outcomes to be assessed

Patients with

previously untreated non-

squamous NSCLC or NSCLC not otherwise

classified



Histological diagnosis of

non- squamous NSCLC or

NSCLC not otherwise classified


EGFR gene mutation testing

and, after presenting with locally advanced

or metastatic disease, use of first-line erlotinib in patients with

tumours expressing EGFR exon 19 deletions or exon 21 point

mutation L858R and use of platinum-based doublet

chemotherapy in patients not expressing these EGFR gene

mutations and in those patients whose EGFR gene mutation status is unknown


Primary comparator

No EGFR gene mutation testing and use of

treatment with platinum- based doublet chemotherapy after presenting with locally

advanced or metastatic disease



No agreed reference standard currently

available, but comparisons should be made against the

specific tests used to generate the evidence to support the effectiveness of first-

line erlotinib (the

“evidentiary”

standard), specifically:

 PCR followed by length analysis in an

ABI Prism 3130 DNA

analyser for exon 19 deletions and a 5’

nuclease PCR (Taqman) assay for exon 21 point

mutations (EURTAC

trial)


 PCR-based direct sequencing

(OPTIMAL trial)




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