OpenOnco · Treatment Plan

Treatment plan — Non-small cell lung cancer

PLAN-NSCLC-ALK-001-V1 · v1 · 2026-05-13

Patient

NSCLC-ALK-001 · Algorithm: ALGO-NSCLC-METASTATIC-1L

DiagnosisNon-small cell lung cancer

MOH / ICD-10C34

ICD-O-38046/3; C34.9

StageIV

Histologyadenocarcinoma

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-ALK-FUSION	EML4-ALK variant 1 (E13;A20)	IA	Molecular evidence option SRC-CIVIC: Level A (Supports, Sensitivity/Response) SRC-CIVIC: Level B (Supports, Sensitivity/Response) Resistance or avoidance signal SRC-CIVIC: Level C ⚠ Resistance SRC-CIVIC: Level D ⚠ Resistance Trial or research option SRC-CIVIC: Level C (Supports, Poor Outcome) SRC-CIVIC: Level D (Supports, Sensitivity/Response) SRC-CIVIC: Level E (Supports, Sensitivity/Response)	EML4-ALK variant 1 (E13;A20) is a stable fusion isoform with longer PFS on 2nd-gen ALK-TKIs vs variant 3. Standard 1L is alectinib or lorlatinib; v1 patients show particularly durable responses to alectinib (~3-year median PFS in subset analyses of ALEX and J-ALEX).	alectinib monotherapy lorlatinib monotherapy	SRC-NCCN-NSCLC-2025 SRC-ESMO-NSCLC-METASTATIC-2024
BIO-ALK-FUSION	EML4-ALK variant 3 (E6;A20)	IA	Molecular evidence option SRC-CIVIC: Level A (Supports, Sensitivity/Response) SRC-CIVIC: Level B (Supports, Sensitivity/Response) Resistance or avoidance signal SRC-CIVIC: Level C ⚠ Resistance SRC-CIVIC: Level D ⚠ Resistance Trial or research option SRC-CIVIC: Level C (Supports, Poor Outcome) SRC-CIVIC: Level D (Supports, Sensitivity/Response) SRC-CIVIC: Level E (Supports, Sensitivity/Response)	EML4-ALK variant 3 is associated with shorter PFS on 2nd-gen ALK-TKIs (crizotinib/alectinib) and a higher rate of acquired G1202R resistance. CROWN (Solomon 2024) showed lorlatinib 1L delivers uniformly long PFS regardless of variant — making lorlatinib the preferred 1L choice for v3.	lorlatinib monotherapy (preferred for v3) alectinib monotherapy (alternative)	SRC-NCCN-NSCLC-2025 SRC-ESMO-NSCLC-METASTATIC-2024
BIO-ALK-FUSION	fusion (gene-level, TKI-naive)	IA	Molecular evidence option SRC-CIVIC: Level A (Supports, Sensitivity/Response) SRC-CIVIC: Level B (Supports, Sensitivity/Response) Resistance or avoidance signal SRC-CIVIC: Level C ⚠ Resistance SRC-CIVIC: Level D ⚠ Resistance Trial or research option SRC-CIVIC: Level C (Supports, Poor Outcome) SRC-CIVIC: Level D (Supports, Sensitivity/Response) SRC-CIVIC: Level E (Supports, Sensitivity/Response)	ALK rearrangement in advanced NSCLC: alectinib (ALEX, Peters 2017) and lorlatinib (CROWN, Solomon 2024 — 5-yr PFS 60%) outperform crizotinib 1L. Lorlatinib has the highest CNS activity. Adjuvant alectinib improves DFS post-resection (ALINA, Solomon 2024).	alectinib monotherapy (1L) lorlatinib monotherapy (1L, preferred for CNS disease) brigatinib monotherapy (1L)	SRC-NCCN-NSCLC-2025 SRC-ESMO-NSCLC-METASTATIC-2024
BIO-ALK-FUSION	G1202R (acquired resistance)	IB	Molecular evidence option SRC-CIVIC: Level A (Supports, Sensitivity/Response) SRC-CIVIC: Level B (Supports, Sensitivity/Response) Resistance or avoidance signal SRC-CIVIC: Level C ⚠ Resistance SRC-CIVIC: Level D ⚠ Resistance Trial or research option SRC-CIVIC: Level C (Supports, Poor Outcome) SRC-CIVIC: Level D (Supports, Sensitivity/Response) SRC-CIVIC: Level E (Supports, Sensitivity/Response)	ALK G1202R is a solvent-front mutation conferring resistance to 1st/2nd-gen ALK-TKIs (crizotinib, alectinib, brigatinib, ceritinib). Lorlatinib remains active and is the standard salvage TKI (Shaw 2019). Acquired G1202R is the most common resistance mutation after alectinib failure (~20-40%).	lorlatinib monotherapy	SRC-NCCN-NSCLC-2025 SRC-ESMO-NSCLC-METASTATIC-2024
BIO-ALK-FUSION	L1196M (acquired resistance)	IB	Molecular evidence option SRC-CIVIC: Level A (Supports, Sensitivity/Response) SRC-CIVIC: Level B (Supports, Sensitivity/Response) Resistance or avoidance signal SRC-CIVIC: Level C ⚠ Resistance SRC-CIVIC: Level D ⚠ Resistance Trial or research option SRC-CIVIC: Level C (Supports, Poor Outcome) SRC-CIVIC: Level D (Supports, Sensitivity/Response) SRC-CIVIC: Level E (Supports, Sensitivity/Response)	ALK L1196M is the gatekeeper mutation conferring resistance to crizotinib but retaining sensitivity to 2nd-gen ALK-TKIs (alectinib, brigatinib, ceritinib) and to lorlatinib. Historically the most common crizotinib-resistance mutation; less prevalent now that crizotinib is no longer 1L.	alectinib monotherapy brigatinib monotherapy lorlatinib monotherapy	SRC-NCCN-NSCLC-2025 SRC-ESMO-NSCLC-METASTATIC-2024
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

Primary current-line option

Standard plan

★ DEFAULT

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

Primary current-line option selected by ALGO-NSCLC-METASTATIC-1L at step 3; branch-driving red flag: RF-NSCLC-ALK-FUSION-ACTIONABLE.

Other current-line alternatives (8 tracks)

Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.

Standard plan

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

Aggressive plan

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

Standard plan

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

Standard plan

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

Standard plan

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

Standard plan

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

Standard plan

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

Aggressive plan

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

Current-line alternative presented for HCP consideration

Why this branch was chosen

Triggers from the patient profile that fired and drove the chosen branch.

Step 1 → branch 2

RF-NSCLC-HIGH-RISK-BIOLOGY ★ winner: Actionable molecular driver detected (EGFR / ALK / ROS1 / KRAS G12C / BRAF V600E / MET ex14 / RET / NTRK / HER2 mut) — driver-targeted TKI / ADC takes precedence over ICI ± chemo regardless of PD-L1 TPS. SRC-NCCN-NSCLC-2025SRC-ESMO-NSCLC-METASTATIC-2024

Step 3 → branch IND-NSCLC-ALK-MET-1L

RF-NSCLC-ALK-FUSION-ACTIONABLE ★ winner: ALK rearrangement / fusion (typically EML4-ALK) — ~5% of NSCLC adenocarcinoma; never-smoker / younger enriched. Treatment-defining: alectinib (ALEX — mPFS 34.8 mo) or lorlatinib (CROWN — 5-y PFS 60%) preferred 1L over crizotinib. Adjuvant alectinib 2 y after resection (ALINA). SRC-NCCN-NSCLC-2025SRC-ESMO-NSCLC-METASTATIC-2024SRC-CROWN-SOLOMON-2021

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)

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Induction · Alectinib monotherapy (ALK+ NSCLC, 1L metastatic OR adjuvant)

28-day cycles × Continuous until progression (metastatic) OR 2 years (ALINA adjuvant)

Standard plan

Induction · Osimertinib monotherapy (EGFR-mut NSCLC, 1L metastatic OR adjuvant)

28-day cycles × Continuous until progression (metastatic) OR 3 years (ADAURA 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

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

MDT brief

Discussion questions (7, 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-BRAF-V600E
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.
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.
→ molecular_geneticist
OQ-BIOMARKER-EGFR-MUTATION
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.
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.
→ molecular_geneticist
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
OQ-BIOMARKER-NTRK-FUSION
What is the status of NTRK1/2/3 gene fusion (BIO-NTRK-FUSION)? It is required by track(s): IND-NSCLC-NTRK-FUSION-1L-LAROTRECTINIB. Expected value: NTRK1, NTRK2, or NTRK3 gene fusion confirmed.
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.
→ molecular_geneticist
OQ-BIOMARKER-RET-FUSION
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).
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
OQ-BIOMARKER-ROS1-FUSION
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).
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.
→ molecular_geneticist

MDT talk tree (9 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	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).
4	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.
5	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.
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-NTRK-FUSION-1L-LAROTRECTINIB. Expected value: NTRK1, NTRK2, or NTRK3 gene fusion confirmed.
7	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).
8	clinical_pharmacist	Specialist review	Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
9	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.
Owns: OQ-BIOMARKER-BRAF-V600E, OQ-BIOMARKER-EGFR-MUTATION, OQ-BIOMARKER-NTRK-FUSION, OQ-BIOMARKER-ROS1-FUSION
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: 2/8 known (25%), 6 missing, 0 default-track gaps
Unevaluated RedFlags: RF-ACTIVE-AUTOIMMUNE-DISEASE-ICI-RISK, 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-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-NTRK-FUSION`	NTRK1/2/3 gene fusion	molecular_geneticist	no	IND-NSCLC-NTRK-FUSION-1L-LAROTRECTINIB	Verify result, method, specimen, and report date before sign-off. Expected/constraint: NTRK1, NTRK2, or NTRK3 gene fusion confirmed
`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)

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	Domain
Cellular therapy specialist (CAR-T)	`cellular_therapy_specialist`	v0.1.0	2026-04-25	cellular_therapy
Clinical pharmacist	`clinical_pharmacist`	v0.1.0	2026-04-25	clinical_pharmacy
Hematologist / oncohematologist	`hematologist`	v0.1.0	2026-04-25	hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)	`hematopathologist`	v0.1.0	2026-04-25	hematopathology
Infectious disease / hepatology	`infectious_disease_hepatology`	v0.1.0	2026-04-25	infectious_diseases
Medical oncologist (solid-tumor chemotherapist)	`medical_oncologist`	v0.1.0	2026-04-25	solid_oncology
Molecular geneticist / molecular oncologist	`molecular_geneticist`	v0.1.0	2026-04-25	molecular_oncology
Palliative care	`palliative_care`	v0.1.0	2026-04-25	palliative_care
Pathologist (general)	`pathologist`	v0.1.0	2026-04-25	pathology
Primary care / family physician	`primary_care`	v0.1.0	2026-04-25	primary_care
Psycho-oncologist	`psychologist`	v0.1.0	2026-04-25	psychosocial
Radiation oncologist	`radiation_oncologist`	v0.1.0	2026-04-25	radiation_oncology
Radiologist	`radiologist`	v0.1.0	2026-04-25	diagnostic_imaging
Social worker / case manager	`social_worker_case_manager`	v0.1.0	2026-04-25	psychosocial
Surgical oncologist	`surgical_oncologist`	v0.1.0	2026-04-25	surgical_oncology
Transplant specialist (BMT)	`transplant_specialist`	v0.1.0	2026-04-25	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-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: 2026-05-13.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT05122806	Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC	NA	RECRUITING	Groupe Francais De Pneumo-Cancerologie	—	Biomarker: enriched Surrogate endpoint only Single country
NCT07354061	Neoadjuvant Therapy With Ensartinib Combined With Chemotherapy for ALK-positive Non - Small Cell Lung Cancer (NSCLC)	PHASE1 / PHASE2	RECRUITING	Tang-Du Hospital	—	Biomarker: enriched Small N (<50) 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
NCT04900935	Patient-centered, Optimal Integration of Survivorship and Palliative Care	NA	RECRUITING	Massachusetts General Hospital	—	Biomarker: enriched Single country
NCT04777084	The Efficacy and Safety of the Bispecific Anti-PD-1/PD-L1 Antibody IBI318 Combined with Lenvatinib in NSCLC.	PHASE2	RECRUITING	Hunan Province Tumor Hospital	—	Surrogate endpoint only Single country
NCT04777175	A Retrospective Study: Evaluation of the Efficacy of Immunotherapy With Rare Mutations in Non-small Cell Lung Cancer	N/A	RECRUITING	Yongchang Zhang	—	Biomarker: enriched Surrogate endpoint only Single country
NCT04087473	Plasma Molecular Profiling in ALK Inhibitor Resistant NSCLC	N/A	RECRUITING	National Cancer Centre, Singapore	—	Biomarker: enriched
NCT04322890	Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation	PHASE2	RECRUITING	Hunan Province Tumor Hospital	—	Biomarker: enriched Surrogate endpoint only Single country
NCT05284539	Efficacy of Platinum-based Chemotherapy Plus Immune Checkpoint Inhibitors for EGFR/ALK/ROS1 Mutant Lung Cancer	PHASE2	RECRUITING	Hunan Province Tumor Hospital	—	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 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
Standard plan Alectinib monotherapy (ALK+ NSCLC, 1L metastatic OR adjuvant) (REG-ALECTINIB-NSCLC)	✓ 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
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
Aggressive plan Pembrolizumab + carboplatin + pemetrexed (NSCLC non-squamous, 1L) (REG-PEMBRO-CHEMO-NSCLC-NONSQ)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Trial · NCT05122806 Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07354061 Neoadjuvant Therapy With Ensartinib Combined With Chemotherapy for ALK-positive Non - Small Cell Lung Cancer (NSCLC) 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 · NCT04900935 Patient-centered, Optimal Integration of Survivorship and Palliative Care No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04777084 The Efficacy and Safety of the Bispecific Anti-PD-1/PD-L1 Antibody IBI318 Combined with Lenvatinib in NSCLC. No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04777175 A Retrospective Study: Evaluation of the Efficacy of Immunotherapy With Rare Mutations in Non-small Cell Lung Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04087473 Plasma Molecular Profiling in ALK Inhibitor Resistant NSCLC No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
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 · NCT05284539 Efficacy of Platinum-based Chemotherapy Plus Immune Checkpoint Inhibitors for EGFR/ALK/ROS1 Mutant Lung Cancer 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.

plan_id: PLAN-NSCLC-ALK-001-V1 | version: 1 | generated: 2026-05-13T10:01:52.758510+00:00

Per FDA non-device CDS positioning (CHARTER §15): Outpatient oncology treatment planning to support tumor-board discussion. Not a medical device; not for autonomous clinical decision-making.

Per FDA non-device CDS positioning (CHARTER §15): Both treatment options below are presented for review. The engine's selection of a 'recommended' default does not constitute a clinical decision. Final treatment selection requires HCP judgment incorporating information not available to the system.

This document is an informational resource supporting tumor-board discussion (per CHARTER §11). It is not a system that makes clinical decisions. Every recommendation must be verified by the treating physician.