| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|---|---|---|---|---|---|
| BIO-BRAF-V600E | V600E | IA | Resistance or avoidance signal | BRAF V600E in advanced NSCLC (≈1-2% of adenocarcinomas): dabrafenib + trametinib gives ORR ~64% in 1L (Planchard et al. Lancet Oncol 2017) and is FDA/EMA-approved across lines. Encorafenib + binimetinib (PHAROS, Riely et al. JCO 2023) ORR 75% in treatment-naïve, 46% pretreated — also FDA-approved 2023. | dabrafenib + trametinib encorafenib + binimetinib |
|
| BIO-PDL1-TPS | (gene-level) | IA |
Evidence cited from clinical guidelines; per-source evidence levels not yet structured. See Phase-2-of-CIViC-pivot for re-cite roadmap. | PD-L1 Tumor Proportion Score (TPS) is the primary predictive biomarker for pembrolizumab selection in metastatic NSCLC without driver alterations. Three threshold-stratified eligibility bands: TPS ≥50% — pembrolizumab monotherapy 1L preferred (KEYNOTE-024; mPFS 10.3 vs 6.0 mo, HR 0.50); TPS ≥1% — pembrolizumab + carboplatin + pemetrexed (non-sq, KEYNOTE-189) or pembrolizumab + carboplatin + paclitaxel/nab-paclitaxel (sq, KEYNOTE-407); TPS 1-49% — chemo-IO combination preferred over pembro mono. Testing by IHC 22C3 pharmDx mandatory on FFPE specimen. Threshold-gated indication selection is performed by the algorithm layer (ALGO-NSCLC, IND-NSCLC-PDL1-HIGH-MET-1L, IND-NSCLC-PDL1-LOW-NONSQ-MET-1L); this BMA entry surfaces ESCAT tier context only. | pembrolizumab monotherapy (TPS≥50% 1L per SRC-KEYNOTE-024-RECK-2016, SRC-NCCN-NSCLC-2025) pembrolizumab + carboplatin + pemetrexed (TPS≥1% non-sq 1L per SRC-KEYNOTE-189-GANDHI-2018) pembrolizumab + carboplatin + paclitaxel/nab-paclitaxel (TPS≥1% sq 1L per SRC-KEYNOTE-407-PAZ-ARES-2018) |
|
| Biomarker | Status |
|---|---|
| BIO-ALK-FUSION | Excluded (negative) |
| BIO-EGFR-MUTATION | Excluded (negative) |
| BIO-NTRK-FUSION | Excluded (negative) |
| BIO-ROS1-FUSION | Excluded (negative) |
| 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 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. |
| 3 | 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). |
| 4 | 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. |
| 5 | 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. |
| 6 | 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). |
| 7 | clinical_pharmacist | Specialist review | Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication. |
| 8 | 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-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-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) |
|---|---|---|---|---|---|---|---|
| NCT06734182 | Neoadjuvant Envafolimab Plus Disitamab Vedotin and Carboplatin in Resectable HER2-Mutant Non-Small-Cell Lung Cancer | PHASE2 | RECRUITING | Guangdong Provincial People's Hospital | — | Small N (<50) Single country | |
| NCT05477979 | The Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer (STRESS-LUNG) | N/A | RECRUITING | Second Xiangya Hospital of Central South University | — | Surrogate endpoint only Single country | |
| NCT05473156 | A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies | PHASE1 / PHASE2 | RECRUITING | AP Biosciences Inc. | — | Surrogate endpoint only Single country | |
| NCT05288205 | Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation | PHASE1 / PHASE2 | RECRUITING | Allist Pharmaceuticals, Inc. | — | Single country | |
| NCT06634979 | Selective Lymph Node Resection for Invasive Non-small Cell Lung Cancer With the CTR of 0.5-1 and the Diameter of ≤ 2 cm | NA | RECRUITING | Fudan University | — | Surrogate endpoint only Single country | |
| NCT05802186 | Stereotactic Body Radiation Therapy Planning With Artificial Intelligence-Directed Dose Recommendation for Treatment of Primary or Metastatic Lung Tumors, RAD-AI Study | NA | RECRUITING | Northwestern University | — | Single country | |
| NCT05624996 | Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer | PHASE3 | RECRUITING | NRG Oncology | — | — | |
| NCT05198154 | ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC | N/A | RECRUITING | Fang Wu | — | Surrogate endpoint only Single country | |
| NCT04165070 | KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A) | PHASE1 / PHASE2 | RECRUITING | Merck Sharp & Dohme LLC | UA | Surrogate endpoint only | |
| NCT07320105 | Postoperative Radiotherapy for Postoperative N2 Metastases of NSCLC in the Immunotherapy Era (Phase II) | PHASE4 | RECRUITING | Fujian Cancer Hospital | — | 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 |
| Trial · NCT06734182 Neoadjuvant Envafolimab Plus Disitamab Vedotin and Carboplatin in Resectable HER2-Mutant Non-Small-Cell Lung Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05477979 The Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer (STRESS-LUNG) No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05473156 A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05288205 Phase 1/2a Study of JAB-21822 Plus JAB-3312 in Patients With Advanced Solid Tumors Harboring KRAS p.G12C Mutation No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06634979 Selective Lymph Node Resection for Invasive Non-small Cell Lung Cancer With the CTR of 0.5-1 and the Diameter of ≤ 2 cm No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05802186 Stereotactic Body Radiation Therapy Planning With Artificial Intelligence-Directed Dose Recommendation for Treatment of Primary or Metastatic Lung Tumors, RAD-AI Study No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05624996 Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05198154 ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04165070 KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A) UA site available — verify enrollment status with site | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07320105 Postoperative Radiotherapy for Postoperative N2 Metastases of NSCLC in the Immunotherapy Era (Phase II) 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: 2026-05-13.