| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|---|---|---|---|---|---|
| ESCAT: clinical review pendingBIO-NTRK-FUSION | NTRK1/3 fusion (rare ~0.1-0.5%) | IA | Resistance or avoidance signal
| NTRK fusion in NSCLC is rare (~0.1-0.5%). Larotrectinib and entrectinib are FDA tumor-agnostic; NSCLC subset of pooled trials shows durable responses including CNS activity (entrectinib has superior CNS penetrance). Tumor-agnostic actionability — NTRK testing is part of comprehensive NGS panels in NSCLC. | entrectinib monotherapy (preferred for CNS disease) larotrectinib monotherapy |
|
| ID | Name | Priority | Category | Where to order | Needed for |
|---|---|---|---|---|---|
| TEST-CBC | Complete Blood Count with Differential | Critical | lab | — | all tracks |
| TEST-CECT-CAP | CECT chest/abdomen/pelvis | Critical | imaging | — | all tracks |
| TEST-CMP | Comprehensive Metabolic Panel | Critical | lab | — | aggressive |
| TEST-LFT | Liver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin) | Critical | lab | — | all tracks |
| TEST-NSCLC-NGS-PANEL | NSCLC comprehensive NGS panel (DNA + RNA fusion) | Critical | — | CSD Lab: M081 CSD Lab: M065 | all tracks |
| TEST-PDL1-IHC | PD-L1 IHC (TPS for NSCLC) | Critical | — | CSD Lab ✓ (code TBC) | all tracks |
| TEST-BRAIN-MRI-CONTRAST | Brain MRI with contrast | Standard | — | — | all tracks |
| TEST-CT-CAP | CT chest/abdomen/pelvis | Standard | imaging | — | standard |
| TEST-ECG | Electrocardiogram | Standard | clinical_assessment | — | standard |
| # | Owner | Topic | Action |
|---|---|---|---|
| 1 | pathologist | Biomarker status BLOCKING | What is the status of PD-L1 Tumor Proportion Score (TPS) (BIO-PDL1-TPS)? It is required by track(s): IND-NSCLC-PDL1-LOW-NONSQ-MET-1L, IND-NSCLC-PDL1-HIGH-MET-1L. Expected value: <50. |
| 2 | hematologist | Staging / disease burden | What is the current LDH? Marker of tumor burden and transformation. |
| 3 | medical_oncologist | Biomarker status | What is the status of BIO-MET-EX14 (BIO-MET-EX14)? It is required by track(s): IND-NSCLC-MET-EX14-1L-CAPMATINIB. Expected value: MET exon 14 skipping mutation confirmed by NGS (DNA or RNA). |
| 4 | medical_oncologist | Biomarker status | What is the status of BIO-RET-FUSION (BIO-RET-FUSION)? It is required by track(s): IND-NSCLC-RET-FUSION-1L-SELPERCATINIB. Expected value: RET fusion confirmed (CCDC6-RET, KIF5B-RET, NCOA4-RET, or other partner). |
| 5 | molecular_geneticist | Biomarker status | What is the status of ALK rearrangement / fusion (BIO-ALK-FUSION)? It is required by track(s): IND-NSCLC-ALK-MET-1L. Expected value: positive. |
| 6 | molecular_geneticist | Biomarker status | What is the status of BRAF V600E mutation (BIO-BRAF-V600E)? It is required by track(s): IND-NSCLC-BRAF-V600E-1L-DAB-TRAM. Expected value: BRAF V600E confirmed by NGS or validated PCR assay. |
| 7 | molecular_geneticist | Biomarker status | What is the status of EGFR mutation status (NSCLC actionable) (BIO-EGFR-MUTATION)? It is required by track(s): IND-NSCLC-EGFR-MUT-MET-1L. Expected value: positive. |
| 8 | molecular_geneticist | Biomarker status | What is the status of ROS1 fusion (BIO-ROS1-FUSION)? It is required by track(s): IND-NSCLC-ROS1-1L-REPOTRECTINIB. Expected value: ROS1 rearrangement confirmed (RNA-NGS preferred — captures partner; FISH/IHC acceptable for rapid diagnosis with NGS confirmation). |
| 9 | clinical_pharmacist | Specialist review | Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication. |
| 10 | social_worker_case_manager | Specialist review | Plan includes drugs without NSZU reimbursement — patient access pathway must be assessed. |
| Missing biomarker | Label | MDT owner | Default track | Required by | Next action |
|---|---|---|---|---|---|
BIO-PDL1-TPS | PD-L1 Tumor Proportion Score (TPS) | pathologist | yes | IND-NSCLC-PDL1-LOW-NONSQ-MET-1L, IND-NSCLC-PDL1-HIGH-MET-1L | Verify result, method, specimen, and report date before sign-off. Expected/constraint: <50 |
BIO-ALK-FUSION | ALK rearrangement / fusion | molecular_geneticist | no | IND-NSCLC-ALK-MET-1L | Verify result, method, specimen, and report date before sign-off. Expected/constraint: positive |
BIO-BRAF-V600E | BRAF V600E mutation | molecular_geneticist | no | IND-NSCLC-BRAF-V600E-1L-DAB-TRAM | Verify result, method, specimen, and report date before sign-off. Expected/constraint: BRAF V600E confirmed by NGS or validated PCR assay |
BIO-EGFR-MUTATION | EGFR mutation status (NSCLC actionable) | molecular_geneticist | no | IND-NSCLC-EGFR-MUT-MET-1L | Verify result, method, specimen, and report date before sign-off. Expected/constraint: positive |
BIO-MET-EX14 | BIO-MET-EX14 | medical_oncologist | no | IND-NSCLC-MET-EX14-1L-CAPMATINIB | Verify result, method, specimen, and report date before sign-off. Expected/constraint: MET exon 14 skipping mutation confirmed by NGS (DNA or RNA) |
BIO-RET-FUSION | BIO-RET-FUSION | medical_oncologist | no | IND-NSCLC-RET-FUSION-1L-SELPERCATINIB | Verify result, method, specimen, and report date before sign-off. Expected/constraint: RET fusion confirmed (CCDC6-RET, KIF5B-RET, NCOA4-RET, or other partner) |
BIO-ROS1-FUSION | ROS1 fusion | molecular_geneticist | no | IND-NSCLC-ROS1-1L-REPOTRECTINIB | Verify result, method, specimen, and report date before sign-off. Expected/constraint: ROS1 rearrangement confirmed (RNA-NGS preferred — captures partner; FISH/IHC acceptable for rapid diagnosis with NGS confirmation) |
| Specialist | skill_id | Version | Last reviewed | Sign-offs | Domain |
|---|---|---|---|---|---|
| Cellular therapy specialist (CAR-T) | cellular_therapy_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| Clinical pharmacist | clinical_pharmacist | v0.1.0 | 2026-04-25 | 0 | clinical_pharmacy |
| Hematologist / oncohematologist | hematologist | v0.1.0 | 2026-04-25 | 0 | hematology_oncology |
| Hematopathologist (lymphoma / leukemia / myeloma) | hematopathologist | v0.1.0 | 2026-04-25 | 0 | hematopathology |
| Infectious disease / hepatology | infectious_disease_hepatology | v0.1.0 | 2026-04-25 | 0 | infectious_diseases |
| Medical oncologist (solid-tumor chemotherapist) | medical_oncologist | v0.1.0 | 2026-04-25 | 0 | solid_oncology |
| Molecular geneticist / molecular oncologist | molecular_geneticist | v0.1.0 | 2026-04-25 | 0 | molecular_oncology |
| Palliative care | palliative_care | v0.1.0 | 2026-04-25 | 0 | palliative_care |
| Pathologist (general) | pathologist | v0.1.0 | 2026-04-25 | 0 | pathology |
| Primary care / family physician | primary_care | v0.1.0 | 2026-04-25 | 0 | primary_care |
| Psycho-oncologist | psychologist | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Radiation oncologist | radiation_oncologist | v0.1.0 | 2026-04-25 | 0 | radiation_oncology |
| Radiologist | radiologist | v0.1.0 | 2026-04-25 | 0 | diagnostic_imaging |
| Social worker / case manager | social_worker_case_manager | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Surgical oncologist | surgical_oncologist | v0.1.0 | 2026-04-25 | 0 | surgical_oncology |
| Transplant specialist (BMT) | transplant_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| NCT | Title | Phase | Status | Sponsor | UA | Signals | Eligibility (excerpt) |
|---|---|---|---|---|---|---|---|
| NCT04322890 | Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation | PHASE2 | RECRUITING | Hunan Province Tumor Hospital | — | Surrogate endpoint only Single country | |
| NCT04996121 | A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors | PHASE1 / PHASE2 | RECRUITING | Xuanzhu Biopharmaceutical Co., Ltd. | — | Biomarker: enriched Surrogate endpoint only Single country | |
| NCT06563999 | Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations. | PHASE2 | RECRUITING | Sun Yat-sen University | — | Biomarker: enriched Single country | |
| NCT01639508 | Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity | PHASE2 | RECRUITING | Memorial Sloan Kettering Cancer Center | — | Biomarker: enriched Surrogate endpoint only Single country |
Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.
| Option | UA registration | NSZU | Cost orientation | Access pathway |
|---|---|---|---|---|
| Aggressive plan Pembrolizumab + carboplatin + pemetrexed (NSCLC non-squamous, 1L) (REG-PEMBRO-CHEMO-NSCLC-NONSQ) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan Osimertinib monotherapy (EGFR-mut NSCLC, 1L metastatic OR adjuvant) (REG-OSIMERTINIB-NSCLC) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan Alectinib monotherapy (ALK+ NSCLC, 1L metastatic OR adjuvant) (REG-ALECTINIB-NSCLC) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Aggressive plan Repotrectinib monotherapy (TRIDENT-1) — ROS1+ NSCLC (TKI-naive or post-prior ROS1-TKI) (REG-REPOTRECTINIB-NSCLC) 1/1 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Standard plan Capmatinib monotherapy (GEOMETRY mono-1) — MET ex14 NSCLC (REG-CAPMATINIB-NSCLC) 1/1 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Standard plan Selpercatinib monotherapy (LIBRETTO-001) — RET fusion+ NSCLC (REG-SELPERCATINIB-NSCLC) 1/1 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Standard plan Dabrafenib + trametinib (BRAF V600E+ NSCLC) (REG-DABRAFENIB-TRAMETINIB-NSCLC) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan Larotrectinib monotherapy (NAVIGATE / SCOUT) — NTRK fusion+ solid tumors (tumor-agnostic, incl. NSCLC) (REG-LAROTRECTINIB-PANTUMOR) 1/1 component drug(s) not on NSZU formulary | ✓ registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Standard plan Pembrolizumab monotherapy (NSCLC PD-L1 ≥50%, driver-negative, 1L) (REG-PEMBRO-MONO-NSCLC) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan Nivolumab + Ipilimumab + 2-Cycle Platinum-Doublet Chemotherapy (CheckMate-9LA) (REG-NIVO-IPI-CHEMO-NSCLC-1L) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Trial · NCT04322890 Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04996121 A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06563999 Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations. No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT01639508 Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-08-18.