| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|---|---|---|---|---|---|
| ESCAT: clinical review pendingBIO-EGFR-MUTATION | T790M | IA | Resistance or avoidance signal | EGFR T790M is the dominant acquired-resistance mechanism after 1st/2nd-gen EGFR-TKI (gefitinib/erlotinib/afatinib). Osimertinib (3rd-gen) is active against T790M and is standard 2L (AURA3, Mok et al. 2017). In the modern era T790M is rarely encountered de novo since osimertinib has moved to 1L; remains relevant after legacy 1L-TKI use. | osimertinib monotherapy |
|
| Biomarker | Status |
|---|---|
| ALK | Excluded (negative) |
| ROS1 | Excluded (negative) |
| PD-L1 TPS | Not in KB — ask clinician to verify |
2IND-NSCLC-2L-EGFR-POST-OSI-AMI-LAZ| 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 | — | all tracks |
| TEST-FISH-PANEL | FISH (Fluorescence In Situ Hybridization) | Critical | genomic | CSD Lab ✓ (code TBC) | desired (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) | desired (aggressive, standard) |
| TEST-BRAIN-MRI-CONTRAST | Brain MRI with contrast | Standard | — | — | all tracks |
| TEST-ECHO | Echocardiography | Standard | imaging | — | standard |
| # | Owner | Topic | Action |
|---|---|---|---|
| 1 | hematologist | Staging / disease burden | What is the current LDH? Marker of tumor burden and transformation. |
| 2 | molecular_geneticist | Biomarker status | What is the status of BRAF V600E mutation (BIO-BRAF-V600E)? It is required by track(s): IND-NSCLC-2L-BRAF-V600E-DAB-TRAM. Expected value: BRAF V600E confirmed by NGS or PCR. |
| 3 | molecular_geneticist | Biomarker status | What is the status of KRAS G12C mutation (BIO-KRAS-G12C)? It is required by track(s): IND-NSCLC-2L-KRAS-G12C-SOTORASIB, IND-NSCLC-2L-KRAS-G12C-ADAGRASIB. Expected value: KRAS G12C mutation confirmed by NGS or allele-specific PCR. |
| 4 | molecular_geneticist | Biomarker status | What is the status of MET alterations (exon 14 skipping or amplification) (BIO-MET)? It is required by track(s): IND-NSCLC-2L-MET-EX14-CAPMATINIB, IND-NSCLC-2L-MET-EX14-TEPOTINIB. Expected value: MET exon 14 skipping mutation confirmed by NGS (RNA-NGS preferred — captures splice-site variants outside hotspots). |
| 5 | molecular_geneticist | Biomarker status | What is the status of MET amplification (high-level copy-number gain) (BIO-MET-AMPLIFICATION)? It is required by track(s): IND-NSCLC-2L-MET-AMP-CAPMATINIB. Expected value: High-level MET amplification (MET/CEP7 ≥4.0 OR mean GCN ≥10) confirmed by FISH OR NGS with assay-specific high-amp threshold. |
| 6 | molecular_geneticist | Biomarker status | What is the status of NTRK1/2/3 gene fusion (BIO-NTRK-FUSION)? It is required by track(s): IND-NSCLC-2L-NTRK-LAROTRECTINIB. Expected value: NTRK1/2/3 fusion confirmed by RNA-NGS (preferred — captures partner) or pan-TRK IHC ≥1+ confirmed by NGS/FISH. |
| 7 | molecular_geneticist | Biomarker status | What is the status of RET alterations (fusion or activating point mutation) (BIO-RET)? It is required by track(s): IND-NSCLC-2L-RET-FUSION-SELPERCATINIB. Expected value: RET fusion confirmed by RNA-NGS (preferred) or FISH; KIF5B-RET most common partner in NSCLC. |
| 8 | pathologist | Biomarker status | What is the status of HER2 status (solid tumors — gastric/GEJ/CRC scoring) (BIO-HER2-SOLID)? It is required by track(s): IND-NSCLC-2L-HER2-MUT-T-DXD. Expected value: HER2-activating mutation confirmed by NGS (kinase-domain insertion most common — Y772_A775dup; also G776 / V777 / L755 / S310 hotspots). |
| 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-BRAF-V600E | BRAF V600E mutation | molecular_geneticist | no | IND-NSCLC-2L-BRAF-V600E-DAB-TRAM | Verify result, method, specimen, and report date before sign-off. Expected/constraint: BRAF V600E confirmed by NGS or PCR |
BIO-HER2-SOLID | HER2 status (solid tumors — gastric/GEJ/CRC scoring) | pathologist | no | IND-NSCLC-2L-HER2-MUT-T-DXD | Verify result, method, specimen, and report date before sign-off. Expected/constraint: HER2-activating mutation confirmed by NGS (kinase-domain insertion most common — Y772_A775dup; also G776 / V777 / L755 / S310 hotspots) |
BIO-KRAS-G12C | KRAS G12C mutation | molecular_geneticist | no | IND-NSCLC-2L-KRAS-G12C-SOTORASIB, IND-NSCLC-2L-KRAS-G12C-ADAGRASIB | Verify result, method, specimen, and report date before sign-off. Expected/constraint: KRAS G12C mutation confirmed by NGS or allele-specific PCR |
BIO-MET | MET alterations (exon 14 skipping or amplification) | molecular_geneticist | no | IND-NSCLC-2L-MET-EX14-CAPMATINIB, IND-NSCLC-2L-MET-EX14-TEPOTINIB | Verify result, method, specimen, and report date before sign-off. Expected/constraint: MET exon 14 skipping mutation confirmed by NGS (RNA-NGS preferred — captures splice-site variants outside hotspots) |
BIO-MET-AMPLIFICATION | MET amplification (high-level copy-number gain) | molecular_geneticist | no | IND-NSCLC-2L-MET-AMP-CAPMATINIB | Verify result, method, specimen, and report date before sign-off. Expected/constraint: High-level MET amplification (MET/CEP7 ≥4.0 OR mean GCN ≥10) confirmed by FISH OR NGS with assay-specific high-amp threshold |
BIO-NTRK-FUSION | NTRK1/2/3 gene fusion | molecular_geneticist | no | IND-NSCLC-2L-NTRK-LAROTRECTINIB | Verify result, method, specimen, and report date before sign-off. Expected/constraint: NTRK1/2/3 fusion confirmed by RNA-NGS (preferred — captures partner) or pan-TRK IHC ≥1+ confirmed by NGS/FISH |
BIO-RET | RET alterations (fusion or activating point mutation) | molecular_geneticist | no | IND-NSCLC-2L-RET-FUSION-SELPERCATINIB | Verify result, method, specimen, and report date before sign-off. Expected/constraint: RET fusion confirmed by RNA-NGS (preferred) or FISH; KIF5B-RET most common partner in NSCLC |
| 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) |
|---|---|---|---|---|---|---|---|
| NCT06709859 | Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III NSCLC | PHASE2 | RECRUITING | Shandong Public Health Clinical Center | — | Small N (<50) Single country | |
| NCT06598527 | Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy Versus Tislelizumab Plus Platinum-based Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Stage Ⅱ-Ⅲ Non-small Cell Lung Cancer: A Phase Ⅲ, Randomized, Multicenter, Prospective Study | PHASE3 | RECRUITING | Yang Hong | — | Single country | |
| NCT04510129 | A Multicenter Cancer Biospecimen Collection Study | N/A | RECRUITING | Cofactor Genomics, Inc. | — | Single country | |
| NCT05487391 | A Study of QL1706 Combined With Platinum-containing Chemotherapy in Adjuvant Treatment of Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection. | PHASE3 | RECRUITING | Qilu Pharmaceutical Co., Ltd. | — | Surrogate endpoint only Single country | |
| NCT06726720 | UmbREALung - A Retrospective and Prospective, Observational, Real World Multi-cohort Study of Patients With Non-small Cell Lung Cancer (NSCLC) Initiating Approved Drugs Developed by AZ or as Part of an AZ Alliance | N/A | RECRUITING | AstraZeneca | — | Surrogate endpoint only Single country | |
| NCT07166003 | Efficacy of Neoadjuvant Immunotherapy in Patients With Lung Cancer | N/A | RECRUITING | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | — | Single country | |
| NCT06917573 | PALACE: Cemiplimab Trial According to ctDNA Levels | PHASE2 | RECRUITING | Fundación GECP | — | Single country | |
| NCT06688422 | Incentive Spirometry to Improve Outcomes in Lung Cancer Patients Undergoing Concurrent Chemotherapy and Radiation Therapy | NA | RECRUITING | The Cooper Health System | — | Single country | |
| NCT06943820 | AK129 Combination Therapy for Advanced Solid Tumors | PHASE1 / PHASE2 | RECRUITING | Akeso | — | Surrogate endpoint only Single country | |
| NCT07337096 | Electro-Acupuncture in Lung cancER : EALER Study | NA | RECRUITING | Guangzhou University of Traditional Chinese Medicine | — | 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 Amivantamab + Lazertinib (MARIPOSA-2) — 2L EGFR-mut NSCLC post-osimertinib (REG-AMIVANTAMAB-LAZERTINIB-NSCLC-2L) 2/2 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Standard plan Amivantamab monotherapy (CHRYSALIS) — 2L EGFR Exon 20 insertion NSCLC (REG-AMIVANTAMAB-MONO-NSCLC-EX20INS) 1/1 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Aggressive plan Lorlatinib monotherapy (ALK+ NSCLC, 1L OR post-2G TKI) (REG-LORLATINIB-NSCLC) 1/1 component drug(s) not on NSZU formulary | ✓ registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Standard plan Entrectinib monotherapy (STARTRK-2) — ROS1+ NSCLC (CNS-active) (REG-ENTRECTINIB-NSCLC) 1/1 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| 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 Sotorasib monotherapy (KRAS G12C+ NSCLC, 2L+) (REG-SOTORASIB-KRAS) 1/1 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Aggressive plan Adagrasib monotherapy (KRYSTAL-1) — 2L+ KRAS G12C+ NSCLC (REG-ADAGRASIB-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 Tepotinib monotherapy (VISION) — MET ex14 NSCLC (REG-TEPOTINIB-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 Dabrafenib + trametinib (BRAF V600E+ NSCLC) (REG-DABRAFENIB-TRAMETINIB-NSCLC) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| 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 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 Trastuzumab deruxtecan (DESTINY-Lung01/02) — HER2-mutant NSCLC 2L+ (REG-T-DXD-NSCLC) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan Docetaxel + Ramucirumab (REVEL) — 2L+ NSCLC post-platinum / post-ICI (REG-DOCETAXEL-RAMUCIRUMAB) 1/2 component drug(s) not on NSZU formulary | ✓ registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Trial · NCT06709859 Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III NSCLC No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06598527 Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy Versus Tislelizumab Plus Platinum-based Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Stage Ⅱ-Ⅲ Non-small Cell Lung Cancer: A Phase Ⅲ, Randomized, Multicenter, Prospective Study No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04510129 A Multicenter Cancer Biospecimen Collection Study No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05487391 A Study of QL1706 Combined With Platinum-containing Chemotherapy in Adjuvant Treatment of Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection. No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06726720 UmbREALung - A Retrospective and Prospective, Observational, Real World Multi-cohort Study of Patients With Non-small Cell Lung Cancer (NSCLC) Initiating Approved Drugs Developed by AZ or as Part of an AZ Alliance No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07166003 Efficacy of Neoadjuvant Immunotherapy in Patients With Lung Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06917573 PALACE: Cemiplimab Trial According to ctDNA Levels No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06688422 Incentive Spirometry to Improve Outcomes in Lung Cancer Patients Undergoing Concurrent Chemotherapy and Radiation Therapy No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06943820 AK129 Combination Therapy for Advanced Solid Tumors No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07337096 Electro-Acupuncture in Lung cancER : EALER Study 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.