Patient
VERIFIED-SCLC-L2-SCLC_RR_TOPOTECAN · Algorithm: ALGO-SCLC-2L
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 |
|---|
| No clinically actionable variants matched in this profile. |
Primary current-line option
- Indication
- IND-SCLC-RR-TOPOTECAN
- Regimen
- Topotecan (SCLC relapsed/refractory)
- Drugs + NSZU
- Topotecan (DRUG-TOPOTECAN) 1.5 mg/m²/day IV over 30 minutes, days 1–5 · Days 1-5, repeat q21 days · IV ⚠ NSZU — not for this indication
- Reason
- Provisional current-line default from ALGO-SCLC-2L: step 1 did not select a treatment branch. Clinical trial preferred at recurrence for ECOG 0-2. Discuss with MDT. Enroll if suitable trial available.
Other current-line alternatives (3 tracks)
Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.
- Indication
- IND-SCLC-RR-LURBINECTEDIN
- Regimen
- Lurbinectedin monotherapy (SCLC, relapsed/refractory, ≥2L)
- Drugs + NSZU
- Lurbinectedin (DRUG-LURBINECTEDIN) 3.2 mg/m² IV over 60 minutes day 1 of every 21-day cycle · Day 1 q3 weeks; continue until progression or unacceptable toxicity · IV ✗ Not registered in UA
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-SCLC-PLATINUM-RECHALLENGE
- Regimen
- Carboplatin + etoposide (SCLC, 1L)
- Drugs + NSZU
- Carboplatin (DRUG-CARBOPLATIN) AUC 5 IV over 30 min · Day 1 of each 21-day cycle · IV ✓ NSZU covered
- Etoposide (DRUG-ETOPOSIDE) 100 mg/m²/day IV over 60 min · Days 1-3 of each 21-day cycle · IV ✓ NSZU covered
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-SCLC-RR-TARLATAMAB
- Regimen
- Tarlatamab — 2L+ extensive-stage SCLC (DeLLphi-301; DLL3 × CD3 BiTE)
- Drugs + NSZU
- Tarlatamab (DRUG-TARLATAMAB) Step-up: 1 mg IV cycle 1 day 1; 10 mg IV cycle 1 day 8 + day 15; then 10 mg IV every 2 weeks · Cycle 1 days 1, 8, 15 (priming + step-up); cycles 2+ q2w (every 14 days) until progression or unacceptable toxicity. Cycle 1 days 1 and 8 require inpatient monitoring ≥22 hours post-infusion for CRS. · IV ✗ Not registered in UA
- 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 | — | all tracks |
| TEST-CREATININE-CL | Creatinine clearance | Critical | lab | — | standard |
| TEST-HBV-SEROLOGY | Hepatitis B Serology Panel (HBsAg, anti-HBc total, anti-HBs) | Critical | lab | — | aggressive |
| TEST-HCV-ANTIBODY | HCV Antibody | Critical | lab | — | aggressive |
| TEST-HIV-SEROLOGY | HIV Antibody/Antigen | Critical | lab | — | aggressive |
| TEST-LDH | Lactate Dehydrogenase | Critical | lab | — | aggressive |
| TEST-LFT | Liver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin) | Critical | lab | — | all tracks |
| TEST-BRAIN-MRI-CONTRAST | Brain MRI with contrast | Standard | — | — | all tracks |
| TEST-CT-CAP | CT chest/abdomen/pelvis | Standard | imaging | — | standard |
| TEST-CT-PET | PET-CT with FDG | Desired | imaging | — | desired (aggressive) |
Red flags — PRO / CONTRA aggressive
PRO-AGGRESSIVE
Triggers that push toward the aggressive track
- SCLC with symptomatic brain metastases requiring emergency intervention: focal deficit, new seizure, raised intracranial pressure. SCLC has high CNS-tropism — brain metastases at presentation in ~10-15%, ~50-80% by death without prophylactic cranial irradiation
Per NCCN-SCLC + ESMO-SCLC 2021: WBRT (30 Gy/10 fx) is preferred for symptomatic SCLC brain mets given multifocality; SRS for limited disease in select cases; dexamethasone 4-16 mg/day for edema. Concurrent platinum-etoposide chemotherapy…
RF-SCLC-BRAIN-METS-EMERGENCYSRC-NCCN-SCLC-2025SRC-ESMO-SCLC-2021 - Active or latent infection requiring resolution / prophylaxis before initiating platinum-etoposide + ICI (atezolizumab / durvalumab) or topotecan in SCLC: HBsAg+ or anti-HBc+ (HBV reactivation on cytotoxic chemo and on ICI), HCV-RNA+, HIV+, active TB, or active uncontrolled infection. SCLC patients are usually heavy smokers with high COPD / TB-history burden — TB screening notably relevant.
HBsAg+ → entecavir or tenofovir from before first cycle through ≥6 months post-last-chemo / ICI. Latent TB common in SCLC population (heavy smoking + lower socioeconomic strata + Ukrainian endemic TB): IGRA / TST + chest imaging at…
RF-SCLC-INFECTION-SCREENINGSRC-NCCN-SCLC-2025SRC-ESMO-SCLC-2021 - Renal dysfunction (CrCl <50) OR severe hepatic impairment — limits cisplatin (use carboplatin AUC 5); dose-modify etoposide for liver impairment.
Carboplatin substitution standard for CrCl <50. Liver dysfunction: reduce etoposide 50% if bilirubin 1.5-3x ULN; avoid if >3x ULN.
RF-SCLC-ORGAN-DYSFUNCTIONSRC-NCCN-SCLC-2025SRC-ESMO-SCLC-2021 - Paraneoplastic syndrome (SIADH, Cushing's, Lambert-Eaton, autoimmune limbic encephalitis) — common in SCLC; neurology / endocrinology consult; symptomatic management may delay or modify systemic therapy initiation.
Paraneoplastic syndromes affect ~15-25% of SCLC patients. Tumor control often resolves the syndrome; severe presentations may require pre-systemic-therapy stabilization.
RF-SCLC-PARANEOPLASTICSRC-NCCN-SCLC-2025SRC-ESMO-SCLC-2021
CONTRA-AGGRESSIVE
Hard contraindications to escalation
What NOT to do
Explicit prohibitive rules, each grounded in a regimen / supportive care / contraindication entity
Standard plan (IND-SCLC-RR-TOPOTECAN)
- Не призначати при CrCl <20 мл/хв — топотекан первинно виводиться нирками; ризик тяжкої токсичності
- Не починати при Grade 3-4 нейтропеnoї або тромбоцитопеnoї — зачекати відновлення; G-КСФ prophylaxis
- Не поєднувати з лурбінектедином — немає підтвердженої комбінації; ATLANTIS (лурбінектедин+доксорубіцин) НЕ перевершив топотекан/CAV
- Не пропускати МРТ головного мозку перед початком — відсутno симптоми ≠ відсутnoсть метастазів у мозок
Aggressive plan (IND-SCLC-RR-LURBINECTEDIN)
- НЕ призначати лурбінектедин у CTFI <30 дnoв від останньої дози платини — поза показаннями FDA-етикетки (платино-резистентno з дуже коротким CTFI мають міnoмальну користь).
- НЕ пропускати Г-КСФ первинну профілактику у важко передлікованих пацієнтів — Grade 3-4 нейтропеnoя ~46%, febrile neutropenia ~5%.
- НЕ комбінувати з сильними CYP3A4-інгібіторами (ітраконазол, кларитроміцин, ритонавір) — AUC підвищення; уникати.
- НЕ призначати при baseline LFTs >3× ULN — гепатичний метаболізм; оборотний transaminitis частий.
- НЕ комбінувати з доксорубіцином поза кліnoчним протоколом — ATLANTIS фаза III НЕ досягла первинної кінцевої точки ЗВ; тільки монотерапія підтримана.
- НЕ підтверджувати план без funding pathway — препарат не зареєстрований в Україno; out-of-pocket USD 8-12K за цикл.
Standard plan (IND-SCLC-PLATINUM-RECHALLENGE)
- Не призначати повторне введення платини при CTFI <90 дnoв — платинорезистентний рецидив, ORR <10%
- Не призначати без оцінки наявності ГМ метастазів — SCLC часто метастазує в ГМ
Aggressive plan (IND-SCLC-RR-TARLATAMAB)
- НЕ призначати тарлатамаб без можливості стаціонарного моnoторингу ≥22 год після інфузії циклу 1 Д1 і Д8 — обов'язково за інструкцією FDA для зниження ризику CRS.
- НЕ розпочинати тарлатамаб у центрі без тоцилізумабу на формулярі та доступу до ВІТ — Grade ≥3 CRS ~1% потребує агресивної підтримки (вазопресори, кисень високого потоку, кортикостероїди в/в).
- НЕ пропускати step-up dosing (1 мг Д1 → 10 мг Д8 → 10 мг Д15) — пряме введення повної дози без праймування суттєво підвищує ризик тяжкого CRS.
- НЕ продовжувати тарлатамаб при Grade 4 CRS або Grade 3-4 ICANS, що рецидивують після протоколу лікування — постійна відміна за інструкцією.
- НЕ призначати при активnoй неконтрольоваnoй інфекції — Т-клітинна перерозподілка + гіпогаммаглобулінемія підвищують ризик сепсису (~10% Grade ≥3).
- НЕ комбінувати з живими вакцинами під час терапії та ≥4 тижno після останньої дози — ризик дисемінованої вакцинної інфекції на тлі активації Т-клітин.
- НЕ підтверджувати план без funding pathway та підтвердженого інфузійного центру — препарат не зареєстрований в Україno; out-of-pocket USD 30-40K за цикл.
- НЕ покладатися на DLL3-IHC для відбору пацієнтів — DeLLphi-301 не використовував DLL3-тестування для включення; більшість МКЛЛ є DLL3-позитивними.
Timeline
Treatment timeline — derived from regimen + monitoring schedule
Standard plan
Induction · Topotecan (SCLC relapsed/refractory)
21-day cycles × Continue until progression or unacceptable toxicity (no fixed cycle cap)
Aggressive plan
Induction · Lurbinectedin monotherapy (SCLC, relapsed/refractory, ≥2L)
21-day cycles × Until progression or unacceptable toxicity
Standard plan
Induction · Carboplatin + etoposide (SCLC, 1L)
21-day cycles × 4-6 cycles (first-line or rechallenge)
Aggressive plan
Induction · Tarlatamab — 2L+ extensive-stage SCLC (DeLLphi-301; DLL3 × CD3 BiTE)
14-day cycles × Until progression or unacceptable toxicity
MDT brief
Discussion questions (1, 0 blocking)
MDT talk tree (2 steps)
| # | Owner | Topic | Action |
|---|
| 1 | hematologist | Staging / disease burden | What is the current LDH? Marker of tumor burden and transformation. |
| 2 | clinical_pharmacist | Specialist review | Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication. |
Skills (recommended) — for consideration (1)
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: 0/0 known (100%), 0 missing, 0 default-track gaps
- Unevaluated RedFlags: RF-LIFESTYLE-TOBACCO-CANCER-PREVENTION, RF-OCC-ASBESTOS-MALIGNANCY-PREVENTION, RF-OCC-DIESEL-EXHAUST-PREVENTION, RF-OCC-FIREFIGHTER-PREVENTION, RF-OCC-IONIZING-RADIATION-PREVENTION, RF-OCC-PAH-PREVENTION, RF-OCC-PAINTERS-PREVENTION, RF-OCC-SILICA-PREVENTION, RF-RADON-MALIGNANCY-PREVENTION, RF-SCLC-BRAIN-METS-EMERGENCY, RF-SCLC-FRAILTY-AGE, RF-SCLC-HIGH-RISK-BIOLOGY, RF-SCLC-INFECTION-SCREENING, RF-SCLC-ORGAN-DYSFUNCTION, RF-SCLC-PARANEOPLASTIC, RF-SCLC-SVC-SYNDROME
Technical MDT skill metadata (1/16 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-DELLPHI-301-AHN-2023: Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer (2023)
- SRC-ESMO-SCLC-2021: ESMO Clinical Practice Guideline on Small Cell Lung Cancer (2021)
- SRC-NCCN-SCLC-2025: NCCN Clinical Practice Guidelines — Small Cell Lung Cancer (2025.v3)
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: 2026-07-15.
| NCT | Title | Phase | Status | Sponsor | UA | Signals | Eligibility (excerpt) |
|---|
| NCT05451602 | HEC169096 in Participants With Advanced Solid Tumors | PHASE1 / PHASE2 | RECRUITING | — | Surrogate endpoint only Single country | |
| NCT07251582 | Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer | PHASE3 | RECRUITING | — | Single country | |
| NCT06758700 | Post-line Treatment With Teniposide for c-Myc-driven Extensive-stage Small Cell Lung Cancer | PHASE2 | RECRUITING | — | Small N (<50) Surrogate endpoint only Single country | |
| NCT07652736 | A Study to Investigate Treatment Patterns and Effectiveness of Tislelizumab in European Patients With Resectable or Advanced Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC) | N/A | RECRUITING | — | Single country | |
| NCT06864624 | Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC | PHASE2 | RECRUITING | — | Small N (<50) Surrogate endpoint only Single country | |
| NCT04170634 | Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT : the MEKANOS Study | N/A | RECRUITING | — | Single country | |
| NCT06970795 | A Study of SYS6040 for Injection in Patients With Advanced Solid Tumors | PHASE1 | RECRUITING | — | Phase 1 only Surrogate endpoint only Single country | |
| NCT06962865 | A Phase Ⅱ Study of RC108 in Combination With Furmonertinib for the First-line Treatment of EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC | PHASE2 | RECRUITING | — | Surrogate endpoint only Single country | |
| NCT04762199 | MRX-2843 and Osimertinib for the Treatment of Advanced EGFR Mutant Non-small Cell Lung Cancer | PHASE1 | RECRUITING | — | Phase 1 only Single country | |
| NCT07096882 | SDTM001 Injection as Adjuvant Therapy for NSCLC Patients After Radical Surgical Resection | PHASE1 | RECRUITING | — | Phase 1 only Small N (<50) 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 Topotecan (SCLC relapsed/refractory) (REG-TOPOTECAN-SCLC-RR) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Aggressive plan Lurbinectedin monotherapy (SCLC, relapsed/refractory, ≥2L) (REG-LURBINECTEDIN-SCLC-RR) 1/1 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Standard plan Carboplatin + etoposide (SCLC, 1L) (REG-CE-SCLC) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Aggressive plan Tarlatamab — 2L+ extensive-stage SCLC (DeLLphi-301; DLL3 × CD3 BiTE) (REG-TARLATAMAB) 1/1 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Trial · NCT05451602 HEC169096 in Participants With Advanced Solid Tumors No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07251582 Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06758700 Post-line Treatment With Teniposide for c-Myc-driven Extensive-stage Small Cell Lung Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07652736 A Study to Investigate Treatment Patterns and Effectiveness of Tislelizumab in European Patients With Resectable or Advanced Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC) No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06864624 Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04170634 Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT : the MEKANOS Study No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06970795 A Study of SYS6040 for Injection in Patients With Advanced Solid Tumors No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06962865 A Phase Ⅱ Study of RC108 in Combination With Furmonertinib for the First-line Treatment of EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04762199 MRX-2843 and Osimertinib for the Treatment of Advanced EGFR Mutant Non-small Cell Lung Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07096882 SDTM001 Injection as Adjuvant Therapy for NSCLC Patients After Radical Surgical Resection 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: 2026-07-15.