Datopotamab deruxtecan monotherapy (TROPION-Lung01) — 2L+ NSCLC
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.
| Components | DRUG-DATOPOTAMAB-DERUXTECAN |
|---|
| ID | REG-DATO-DXD-NSCLC-2L |
|---|---|
| Type | Regimen |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-ESMO-NSCLC-METASTATIC-2024 SRC-NCCN-NSCLC-2025 |
Notes
TROPION-Lung01 (phase III, n=604): Dato-DXd vs docetaxel in 2L+ advanced NSCLC after platinum-based chemo + checkpoint inhibitor. Nonsquamous PFS benefit (mPFS 5.6 vs 3.7 mo, HR 0.84) drove FDA approval scope restriction to EGFR-mutant NSCLC (TROPION-Lung05 supporting). Squamous subgroup did not benefit. ILD adjudicated rate ~8% all-grade; ocular + stomatitis are dominant non-pulmonary AEs. Patient selection: prefer for nonsquamous, especially EGFR-mutant post-osimertinib + chemo.
Used By
Indication
IND-NSCLC-2L-DATO-DXD- IND-NSCLC-2L-DATO-DXD