Patient
NSCLC-TMB-HIGH-001 · Algorithm: ALGO-NSCLC-METASTATIC-1L
Clinical significance of mutations (ESCAT)
Tumor-board context — the engine does not use these tiers to rank tracks
| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|
| BIO-PDL1-TPS | (gene-level) | IA | - SRC-KEYNOTE-024-RECK-2016
- SRC-KEYNOTE-042-MOK-2019
- SRC-KEYNOTE-189-GANDHI-2018
- SRC-KEYNOTE-407-PAZ-ARES-2018
- SRC-NCCN-NSCLC-2025
- SRC-ESMO-NSCLC-METASTATIC-2024
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) | - SRC-KEYNOTE-024-RECK-2016
- SRC-KEYNOTE-042-MOK-2019
- SRC-KEYNOTE-189-GANDHI-2018
- SRC-KEYNOTE-407-PAZ-ARES-2018
- SRC-NCCN-NSCLC-2025
- SRC-ESMO-NSCLC-METASTATIC-2024
|
| Biomarker | Status |
|---|
| BIO-TMB-HIGH | BIO definition in KB; no ESCAT BMA entry — verify with clinician |
| BIO-TMB | Not in KB — ask clinician to verify |
Primary current-line option
- Indication
- IND-NSCLC-PDL1-LOW-NONSQ-MET-1L
- Regimen
- Pembrolizumab + carboplatin + pemetrexed (NSCLC non-squamous, 1L)
- Drugs + NSZU
- Pembrolizumab (DRUG-PEMBROLIZUMAB) 200 mg IV q3 weeks · Continuous up to 2 years · IV ⚠ NSZU — not for this indication
- Carboplatin (DRUG-CARBOPLATIN) AUC 5 IV · Cycles 1-4 · IV ✓ NSZU covered
- Pemetrexed (DRUG-PEMETREXED) 500 mg/m² IV · Cycles 1-4 + maintenance until progression · IV ✓ NSZU covered
- Reason
- Primary current-line option selected by ALGO-NSCLC-METASTATIC-1L at step 10.
Other current-line alternatives (9 tracks)
Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.
- Indication
- IND-NSCLC-EGFR-MUT-MET-1L
- Regimen
- Osimertinib monotherapy (EGFR-mut NSCLC, 1L metastatic OR adjuvant)
- Drugs + NSZU
- Osimertinib (DRUG-OSIMERTINIB) 80 mg PO once daily · Continuous · PO ⚠ NSZU — not for this indication
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-NSCLC-ALK-MET-1L
- Regimen
- Alectinib monotherapy (ALK+ NSCLC, 1L metastatic OR adjuvant)
- Drugs + NSZU
- Alectinib (DRUG-ALECTINIB) 600 mg PO BID with food · Continuous · PO ⚠ NSZU — not for this indication
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-NSCLC-ROS1-1L-REPOTRECTINIB
- Regimen
- Repotrectinib monotherapy (TRIDENT-1) — ROS1+ NSCLC (TKI-naive or post-prior ROS1-TKI)
- Drugs + NSZU
- Repotrectinib (DRUG-REPOTRECTINIB) 160 mg PO once daily x14 days, then 160 mg PO BID continuous (lead-in mitigates CNS-AE) · Lead-in then continuous · PO ✗ Not registered in UA
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-NSCLC-MET-EX14-1L-CAPMATINIB
- Regimen
- Capmatinib monotherapy (GEOMETRY mono-1) — MET ex14 NSCLC
- Drugs + NSZU
- Capmatinib (DRUG-CAPMATINIB) 400 mg PO BID with food · Continuous · PO ✗ Not registered in UA
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-NSCLC-RET-FUSION-1L-SELPERCATINIB
- Regimen
- Selpercatinib monotherapy (LIBRETTO-001) — RET fusion+ NSCLC
- Drugs + NSZU
- Selpercatinib (DRUG-SELPERCATINIB) 160 mg PO BID with food (≥50 kg); 120 mg BID (<50 kg) · Continuous · PO ✗ Not registered in UA
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-NSCLC-BRAF-V600E-1L-DAB-TRAM
- Regimen
- Dabrafenib + trametinib (BRAF V600E+ NSCLC)
- Drugs + NSZU
- Dabrafenib (DRUG-DABRAFENIB) 150 mg PO BID · Continuous · PO ⚠ NSZU — not for this indication
- Trametinib (DRUG-TRAMETINIB) 2 mg PO once daily · Continuous · PO ⚠ NSZU — not for this indication
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-NSCLC-NTRK-FUSION-1L-LAROTRECTINIB
- Regimen
- Larotrectinib monotherapy (NAVIGATE / SCOUT) — NTRK fusion+ solid tumors (tumor-agnostic, incl. NSCLC)
- Drugs + NSZU
- Larotrectinib (DRUG-LAROTRECTINIB) 100 mg PO BID (adults); pediatric 100 mg/m² BID · Continuous · PO ⚠ Out-of-pocket
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-NSCLC-PDL1-HIGH-MET-1L
- Regimen
- Pembrolizumab monotherapy (NSCLC PD-L1 ≥50%, driver-negative, 1L)
- Drugs + NSZU
- Pembrolizumab (DRUG-PEMBROLIZUMAB) 200 mg IV q3 weeks (or 400 mg q6 weeks) · Continuous until progression OR 2 years · IV ⚠ NSZU — not for this indication
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-NSCLC-DRIVER-NEG-MET-1L-NIVO-IPI-CHEMO
- Regimen
- Nivolumab + Ipilimumab + 2-Cycle Platinum-Doublet Chemotherapy (CheckMate-9LA)
- Drugs + NSZU
- Nivolumab (DRUG-NIVOLUMAB) 360 mg IV over 30 min · Day 1 of each 21-day cycle; indefinite until progression or unacceptable toxicity · IV ⚠ NSZU — not for this indication
- Ipilimumab (DRUG-IPILIMUMAB) 1 mg/kg IV over 30 min · Every 6 weeks (q6w); up to 2 years total · IV ⚠ NSZU — not for this indication
- Carboplatin (DRUG-CARBOPLATIN) AUC 6 IV (squamous) or AUC 5 IV (non-squamous) · Day 1 of cycles 1–2 only (2 cycles total) · IV ✓ NSZU covered
- Paclitaxel (DRUG-PACLITAXEL) 200 mg/m² IV (squamous histology primary chemo partner) · Day 1 of cycles 1–2 only · IV ✓ NSZU covered
- Reason
- Current-line alternative presented for HCP consideration
Pre-treatment investigations
Investigations before treatment start · critical / standard / desired · merged across tracks
| 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 |
Red flags — PRO / CONTRA aggressive
PRO-AGGRESSIVE
Triggers that push toward the aggressive track
- NSCLC with symptomatic brain metastases requiring emergency intervention: focal deficit, new seizure, raised intracranial pressure, or impending herniation. Asymptomatic / oligometastatic brain disease handled separatelyRF-NSCLC-BRAIN-METS-EMERGENCY
- NSCLC with malignant epidural spinal cord compression (MESCC): new motor deficit, sensory level, bowel/bladder dysfunction, severe back pain with vertebral metastasis on imaging — neurosurgical/radiation emergencyRF-NSCLC-CORD-COMPRESSION
- NSCLC with symptomatic malignant pleural / pericardial effusion: dyspnea at rest, hypoxia, hemodynamic compromise (effusion-driven hypotension or tamponade physiology)RF-NSCLC-MALIGNANT-EFFUSION
- ROS1 fusion (CD74-ROS1, EZR-ROS1, others) — ~1-2% of NSCLC adenocarcinoma; never-smoker enriched. Treatment-defining: entrectinib (CNS-active) or repotrectinib (TRIDENT-1, including post-crizotinib resistance) preferred 1L; crizotinib historic option.
RF-NSCLC-ROS1-FUSION-ACTIONABLE
- NSCLC with superior vena cava syndrome: facial/upper-extremity edema, distended neck/chest veins, dyspnea, plethora, headache — most often right-upper-lobe / bulky mediastinal NSCLCRF-NSCLC-SVC-SYNDROME
CONTRA-AGGRESSIVE
Hard contraindications to escalation
What NOT to do
Explicit prohibitive rules, each grounded in a regimen / supportive care / contraindication entity
Aggressive plan (IND-NSCLC-ROS1-1L-REPOTRECTINIB)
- Do NOT skip lead-in dosing (14 days at 160 mg daily before BID) — direct BID sharply worsens CNS-AE.
- Do NOT ignore vestibular AE counseling — patients must understand that dizziness ~60% usually adapts in 4-8 weeks.
- Do NOT combine with strong CYP3A4 inhibitors or inducers without dose modification.
- Do NOT ignore long-term skeletal fracture monitoring — bone density q-yearly.
- Do NOT stop for reversible Grade 1-2 dizziness — usually adapts; reduction to 120 mg BID for Grade 3.
- Do NOT confirm plan without funding pathway — repotrectinib not registered in Ukraine.
- Do NOT use in baseline severe vestibular dysfunction — additive CNS toxicity.
Standard plan (IND-NSCLC-MET-EX14-1L-CAPMATINIB)
- Не призначати без підтвердження MET екзон 14 пропуску — MET ампліфікація без ex14 пропуску не є показанням
- Не призначати при наявності EGFR/ALK — ці драйвери мають пріоритет
Standard plan (IND-NSCLC-RET-FUSION-1L-SELPERCATINIB)
- Не призначати без підтвердження RET фузії — RET-мутоваno (MEN2 без фузії) — інший ландшафт
- Не ігнорувати ЕКГ — QTc подовження при селперкатиnoбі
Standard plan (IND-NSCLC-BRAF-V600E-1L-DAB-TRAM)
- НЕ застосовувати при BRAF non-V600E — парадоксальна активація кінази
- Не ігнорувати дерматологічний нагляд — ризик кутанного SCC
- Не застосовувати монотерапію дабрафеnoбом без траметиnoбу — BRAF монотерапія при NSCLC не рекомендована
Standard plan (IND-NSCLC-NTRK-FUSION-1L-LAROTRECTINIB)
- Не призначати при NTRK мутації без фузії — тільки фузійno NTRK є показанням
- Не застосовувати з сильними CYP3A4 індукторами (рифампіцин тощо)
Standard plan (IND-NSCLC-DRIVER-NEG-MET-1L-NIVO-IPI-CHEMO)
- EGFR-mutant or ALK+ NSCLC: targeted therapy (osimertinib/ALK-TKI) is superior — do not use nivo+ipi+chemo as first-line
- Active autoimmune disease requiring systemic immunosuppression: nivolumab and ipilimumab are contraindicated
- Severe interstitial lung disease or prior pneumonitis: markedly elevated risk of immune-mediated pneumonitis
- ECOG PS ≥3: no safety/efficacy data; platinum-doublet chemotherapy contraindicated
Timeline
Treatment timeline — derived from regimen + monitoring schedule
Aggressive plan
Induction · Pembrolizumab + carboplatin + pemetrexed (NSCLC non-squamous, 1L)
21-day cycles × 4 cycles induction; then pembro + pemetrexed maintenance until progression OR 2 years total pembro
Standard plan
Induction · Osimertinib monotherapy (EGFR-mut NSCLC, 1L metastatic OR adjuvant)
28-day cycles × Continuous until progression (metastatic) OR 3 years (ADAURA adjuvant)
Standard plan
Induction · Alectinib monotherapy (ALK+ NSCLC, 1L metastatic OR adjuvant)
28-day cycles × Continuous until progression (metastatic) OR 2 years (ALINA adjuvant)
Aggressive plan
Induction · Repotrectinib monotherapy (TRIDENT-1) — ROS1+ NSCLC (TKI-naive or post-prior ROS1-TKI)
28-day cycles × Continuous until progression or unacceptable toxicity
Standard plan
Induction · Capmatinib monotherapy (GEOMETRY mono-1) — MET ex14 NSCLC
28-day cycles × Continuous until progression or unacceptable toxicity
Standard plan
Induction · Selpercatinib monotherapy (LIBRETTO-001) — RET fusion+ NSCLC
28-day cycles × Continuous until progression or unacceptable toxicity
Standard plan
Induction · Dabrafenib + trametinib (BRAF V600E+ NSCLC)
28-day cycles × Continuous until progression
Standard plan
Induction · Larotrectinib monotherapy (NAVIGATE / SCOUT) — NTRK fusion+ solid tumors (tumor-agnostic, incl. NSCLC)
28-day cycles × Continuous until progression or unacceptable toxicity
Standard plan
Induction · Pembrolizumab monotherapy (NSCLC PD-L1 ≥50%, driver-negative, 1L)
21-day cycles × Up to 2 years (35 cycles q3w) — KEYNOTE-024 protocol
Standard plan
Induction · Nivolumab + Ipilimumab + 2-Cycle Platinum-Doublet Chemotherapy (CheckMate-9LA)
21-day cycles × Nivo q3w + Ipi q6w until progression/toxicity (up to 2 years); platinum-doublet chemo 2 cycles only
MDT brief
Discussion questions (2, 0 blocking)
OQ-LDH-CURRENT
What is the current LDH? Marker of tumor burden and transformation.
LDH is part of the prognostic indices of indolent lymphomas.
→ hematologist
OQ-BIOMARKER-MET-EX14
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).
A treatment-track biomarker requirement is missing from the patient profile; the MDT should verify the test result, method, specimen, and date before relying on this option.
→ medical_oncologist
MDT talk tree (5 steps)
| # | Owner | Topic | Action |
|---|
| 1 | hematologist | Staging / disease burden | What is the current LDH? Marker of tumor burden and transformation. |
| 2 | 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). |
| 3 | clinical_pharmacist | Specialist review | Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication. |
| 4 | molecular_geneticist | Specialist review | Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed. |
| 5 | social_worker_case_manager | Specialist review | Plan includes drugs without NSZU reimbursement — patient access pathway must be assessed. |
Skills (recommended) — for consideration (3)
- Clinical pharmacist recommended
Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
- Molecular geneticist / molecular oncologist recommended
Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed.
- Social worker / case manager recommended
Plan includes drugs without NSZU reimbursement — patient access pathway must be assessed.
Data quality
Usable with caveats. No critical default-track gap was found, but the MDT should review the listed caveats before final sign-off.
- Biomarker coverage: 7/8 known (88%), 1 missing, 0 default-track gaps
- Unevaluated RedFlags: RF-ACTIVE-AUTOIMMUNE-DISEASE-ICI-RISK, RF-NSCLC-ALK-FUSION-ACTIONABLE, RF-NSCLC-BRAF-V600E-ACTIONABLE, RF-NSCLC-BRAIN-METS-EMERGENCY, RF-NSCLC-CORD-COMPRESSION, RF-NSCLC-EGFR-C797S-RESISTANCE, RF-NSCLC-EGFR-EX19DEL-ACTIONABLE, RF-NSCLC-EGFR-EX20INS-ACTIONABLE, RF-NSCLC-EGFR-T790M-ACTIONABLE, RF-NSCLC-FRAILTY-AGE, RF-NSCLC-HER2-MUT-ACTIONABLE, RF-NSCLC-HER3-HIGH-PATRITUMAB-CANDIDATE, RF-NSCLC-HIGH-RISK-BIOLOGY, RF-NSCLC-INFECTION-SCREENING, RF-NSCLC-KRAS-G12C-ACTIONABLE, RF-NSCLC-MALIGNANT-EFFUSION, RF-NSCLC-MET-AMP-ACTIONABLE, RF-NSCLC-MET-EX14-ACTIONABLE, RF-NSCLC-NRG1-FUSION-ZENO-CANDIDATE, RF-NSCLC-NTRK-FUSION-ACTIONABLE, RF-NSCLC-ORGAN-DYSFUNCTION, RF-NSCLC-PDL1-50-PLUS, RF-NSCLC-RET-FUSION-ACTIONABLE, RF-NSCLC-ROS1-FUSION-ACTIONABLE, RF-NSCLC-SVC-SYNDROME, RF-NSCLC-TRANSFORMATION-PROGRESSION, RF-NSCLC-TROP2-DATO-CANDIDATE
| Missing biomarker | Label | MDT owner | Default track | Required by | Next action |
|---|
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) |
Technical MDT skill metadata (3/16 activated in this plan)
All registered virtual specialists. ✓ — activated for this case; ○ — not activated (available for other clinical scenarios).
| 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 |
Sources cited
- SRC-BRF113928-PLANCHARD-2016: Dabrafenib plus trametinib in patients with previously treated BRAF(V600E)-mutant metastatic non-small-cell lung cancer: an open-label, multicentre phase 2 trial (BRF113928) (2016)
- SRC-CHECKMATE-9LA-PAZ-ARES-2021: First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial (2021)
- SRC-ESMO-NSCLC-METASTATIC-2024: ESMO Clinical Practice Guideline on Metastatic Non-Small Cell Lung Cancer (2024)
- SRC-GEOMETRY-WOLF-2020: Capmatinib in MET Exon 14-Mutated or MET-Amplified Non-Small-Cell Lung Cancer (GEOMETRY mono-1) (2020)
- SRC-KEYNOTE-024-RECK-2016: Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer (2016)
- SRC-KEYNOTE-189-GANDHI-2018: Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer (2018)
- SRC-LIBRETTO001-DRILON-2020: Efficacy of Selpercatinib in RET Fusion-Positive Non-Small-Cell Lung Cancer (LIBRETTO-001) (2020)
- SRC-NCCN-NSCLC-2025: NCCN Clinical Practice Guidelines — Non-Small Cell Lung Cancer (2025.v8)
- SRC-TRIDENT1-DRILON-2024: Repotrectinib in ROS1 Fusion-Positive Non-Small-Cell Lung Cancer (TRIDENT-1) (2024)
Experimental options (clinical trials)
Third plan track — open-enrollment trials from ClinicalTrials.gov. Render-time metadata; engine selection is not affected by this block (CHARTER §8.3). Last synced: 2026-05-12.
| NCT | Title | Phase | Status | Sponsor | UA | Signals | Eligibility (excerpt) |
|---|
| NCT05086692 | A Beta-only IL-2 ImmunoTherapY Study | PHASE1 / PHASE2 | RECRUITING | — | — | |
| NCT06270706 | A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors | PHASE1 | RECRUITING | — | Phase 1 only Single country | |
| NCT05592626 | A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors | PHASE1 / PHASE2 | RECRUITING | — | Biomarker: enriched Surrogate endpoint only | |
Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.
Option availability in Ukraine
Per-track UA registration · NSZU · cost · access pathway. Render-time metadata; engine selection does not depend on these fields (CHARTER §8.3).
| 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 · NCT05086692 A Beta-only IL-2 ImmunoTherapY Study No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06270706 A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05592626 A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors 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: 2026-05-12.