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genoCDS is a clinical reference tool for qualified healthcare professionals only. Content is derived from published guidelines and regulatory sources and may contain errors or outdated information. It is not a substitute for professional medical judgment, institutional protocols, or individual patient assessment. Always verify recommendations against current primary sources before making clinical decisions. Full disclaimer →
Stage Stage IIA
Tumor >4–5 cm, no nodal or distant metastasis (T2b, N0, M0). Resectable.
4 test recommendations across 1 clinical indication
Resectable Stage IIA adenocarcinoma. EGFR and ALK testing required — both osimertinib (ADAURA) and alectinib (ALINA) adjuvant approvals extend to Stage IIA. PD-L1 required for adjuvant pembrolizumab consideration (PEARLS/KEYNOTE-091, applicable ≥Stage IB with tumor ≥4 cm or resected ≥Stage II).
Required — 4 tests
EGFR Mutation Analysis
EGFR
Analysis of EGFR gene for sensitizing mutations in exons 18–21 (exon 19 deletions, exon 21 L858R, exon 18 G719X/S768I/L861Q, exon 20 insertions) and resistance mutations (T790M, C797S). May be performed by PCR-based assay or as part of an NGS panel. Cobas EGFR Mutation Test v2 is FDA-approved companion diagnostic for osimertinib (Tagrisso). EGFR mutations are present in 10–15% of Caucasian patients and 30–40% of Asian patients with adenocarcinoma.
Ordering Note
Adjuvant osimertinib approved for EGFR-mutant resected Stage IB–IIIA. Testing required before treatment planning.
Specimen
Evidence
ALK Gene Rearrangement
ALK
Detection of ALK (anaplastic lymphoma kinase) gene fusions, most commonly EML4-ALK. Testing methods include FISH (Vysis ALK Break Apart FISH Probe Kit — FDA-approved companion Dx for crizotinib/ceritinib), IHC (D5F3 clone, FDA-approved for crizotinib), and RNA-based NGS (preferred for detection of all ALK fusion variants). ALK fusions occur in 3–7% of adenocarcinoma, often in younger, never- or light-smokers.
Ordering Note
Adjuvant alectinib approved for ALK+ resected Stage IB–IIIA (ALINA trial). ALK testing required at Stage IIA.
Specimen
Evidence
Comprehensive Solid Tumor NGS Panel
Comprehensive NGS
Next-generation sequencing panel covering ≥300 cancer-relevant genes, including all major NSCLC drivers (EGFR, ALK, ROS1, BRAF, KRAS, MET, RET, NTRK, HER2, FGFR), plus tumor mutational burden (TMB) and microsatellite instability (MSI). Examples include FoundationOne CDx, Tempus xT, Caris MI Transcriptome, and equivalent institutional panels. Preferred over single-gene sequential testing for efficiency and cost-effectiveness.
Ordering Note
NCCN Category 1: broad molecular profiling required for adenocarcinoma. Comprehensive panel covers EGFR and ALK simultaneously with all other actionable drivers.
Specimen
PD-L1 Expression by Immunohistochemistry (IHC)
PD-L1 IHC
Measurement of PD-L1 (programmed death-ligand 1; CD274) protein expression on tumor cells by IHC. Reported as Tumor Proportion Score (TPS) for NSCLC. Key thresholds: TPS <1% (PD-L1 negative), TPS 1–49% (low expression), TPS ≥50% (high expression). FDA-approved companion diagnostics: 22C3 pharmDx (pembrolizumab), 28-8 pharmDx (nivolumab), SP142 (atezolizumab), SP263 (durvalumab). PD-L1 ≥50% qualifies for pembrolizumab monotherapy first-line; all TPS levels are relevant for combination chemo-immunotherapy selection.
Ordering Note
PD-L1 required — adjuvant pembrolizumab (KEYNOTE-091) approved for resected Stage II–IIIA regardless of PD-L1 expression level. PD-L1 status informs risk stratification and may guide sequential therapy choices.
Specimen
Evidence
KEYNOTE-091 (PEARLS): adjuvant pembrolizumab approved for resected Stage II–IIIA NSCLC.
Payer Coverage
Payer Coverage Summary
Coverage status as of last policy review. Prior authorization requirements and coverage criteria may change. Verify directly with each payer before ordering.
| Test | Medicare (CMS) | UnitedHealth | Anthem BCBS | Humana | Cigna | Aetna |
|---|---|---|---|---|---|---|
| EGFR | Covered | Covered | Covered | Covered | Covered | Covered |
| ALK | Covered | Covered | Covered | Covered | Covered | Covered |
| Comprehensive NGS | Covered | Covered | Covered | Prior Auth | Covered | Covered |
| PD-L1 IHC | Covered | Covered | Covered | Covered | Covered | Covered |
Coverage data last verified via automated policy research. Always confirm current policies with each payer.
Recommendations on this page are derived from publicly available guidelines (NCCN, ASCO, ESMO, FDA, OncoKB) and are paraphrased for reference. They do not constitute medical advice. Evidence levels reflect the grading systems of each respective organization and should be interpreted in clinical context. This reference is updated periodically but may not reflect the most recent guideline revisions.