Furthermore, we provide a comprehensive update on recent and ongoing preclinical and clinical studies, highlighting novel CNS-penetrant agents with demonstrated intracranial efficacy. Understanding these mechanisms and refining targeted approaches are critical to improving CNS disease control, survival outcomes, and quality of life for NSCLC patients with brain involvement.

1 day ago

Review • Journal • PD(L)-1 Biomarker • IO biomarker

EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)

EGFR mutation • ALK mutation

Efficacy and safety of lorlatinib in first-line and subsequent-line treatments for patients with ALK-positive non-small cell lung cancer: a single-center real-world study in China. (PubMed, Transl Lung Cancer Res)

Effective management of lorlatinib-related adverse events, through close monitoring and timely intervention, is essential to enhance patient tolerance. Lorlatinib has progressively transformed the therapeutic landscape for patients with ALK + NSCLC.

1 day ago

Journal • Real-world evidence

ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase)

ALK positive • MET amplification • ALK fusion • ALK mutation • MET mutation

Lorbrena (lorlatinib)

Impact of smoking on immune feature and prognosis in unresectable stage III anaplastic lymphoma kinase positive non-small-cell lung cancer. (PubMed, Front Oncol)

Smokers exhibited a significantly poorer OS and DMFS, and may require more risk-adapted treatment strategies, such as the combination of CRT with upfront ALK TKIs. These findings suggest that smoking may adversely affect survival by modulating the tumor immune microenvironment.

1 day ago

Journal

ALK (Anaplastic lymphoma kinase)

ALK positive • ALK mutation

Treating Patients With Melanoma and ALK Alterations With Ensartinib (clinicaltrials.gov)

P2, N=18, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2026 --> Jan 2027

5 days ago

Trial completion date • Trial primary completion date

BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase)

BRAF V600 • ALK fusion • ALK mutation

Ensacove (ensartinib)

The Correlation Among PD-L1 Expression and the Driver Genes Status in Malignant Pleural Effusion of Lung Adenocarcinoma. (PubMed, Cytopathology)

Our findings suggest that PD-L1 immunohistochemistry is effective for evaluating pleural fluid cytological specimens and that PD-L1 expression is significantly higher in lung adenocarcinoma patients with malignant pleural effusions associated with the KRAS, ALK and BRAF mutations.

7 days ago

Journal • Pleural effusion • PD(L)-1 Biomarker • IO biomarker

EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MET (MET proto-oncogene, receptor tyrosine kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)

PD-L1 expression • KRAS mutation • EGFR mutation • BRAF mutation • PIK3CA mutation • ALK mutation • MET mutation

VENTANA PD-L1 (SP263) Assay

Immunotherapeutic advances in pediatric neuroblastoma: Overcoming resistance through biomarker-guided combinations. (PubMed, Biomed Pharmacother)

Recent advances in immunotherapy have reshaped the treatment landscape, with anti-GD2 monoclonal antibodies such as dinutuximab and naxitamab demonstrating significant clinical benefit, especially when combined with granulocyte-macrophage colony-stimulating factor (GM-CSF)...This review synthesizes current evidence on immunotherapeutic strategies in neuroblastoma, highlighting resistance pathways, biomarker-driven approaches, and the evolving clinical trial landscape. Future directions emphasize personalized, biomarker-guided immunotherapy to improve efficacy, reduce toxicity, and establish durable, curative outcomes for children with neuroblastoma.

9 days ago

Review • Journal • IO biomarker

ALK (Anaplastic lymphoma kinase) • CD276 (CD276 Molecule) • CSF2 (Colony stimulating factor 2) • L1CAM (L1 cell adhesion molecule)

ALK mutation

Unituxin (dinutuximab)

10d

STAR-121: Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)

P3, N=1021, Active, not recruiting, Gilead Sciences | Recruiting --> Active, not recruiting

10 days ago

Enrollment closed • IO biomarker

EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • NTRK (Neurotrophic receptor tyrosine kinase)

BRAF mutation • ALK mutation • RET mutation

Keytruda (pembrolizumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • Yutuo (zimberelimab) • domvanalimab (AB154)

11d

Clinical study and mechanism of spleen-strengthening traditional Chinese medicine WD-3 combined with immunotherapy for lung cancer based on the theory of "Pei Tu Shengjin" (ChiCTR2500115477)

P=N/A, N=220, Recruiting, Wuxi Hospital of Traditional Chinese Medicine; Wuxi Hospital of Traditional Chinese Medicine

11 days ago

New trial

EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)

EGFR mutation • ALK mutation • MET mutation

11d

Exploratory clinical study on preserving organs in patients with stage II-III non-small cell lung cancer(The Future Star) (ChiCTR2500115167)

P4, N=598, Recruiting, Jiangsu Cancer Hospital; Jiangsu Cancer Hospital

11 days ago

New P4 trial

EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)

EGFR mutation • EGFR L858R • EGFR T790M • ALK mutation

carboplatin • albumin-bound paclitaxel • pemetrexed • Ensacove (ensartinib) • Ameile (aumolertinib) • AiRuiLi (adebrelimab)

11d

A randomized controlled clinical study on postoperative adjuvant targeted therapy and MRD observation for stage IA non-small cell lung cancer (ChiCTR2500112620)

P4, N=178, Not yet recruiting, Beijing chest hospital capital medical university; Beijing Chest Hospital Capital Medical University

11 days ago

New P4 trial

EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)

EGFR mutation • ALK positive • ALK fusion • ALK mutation • EGFR positive

Conmana (icotinib) • Ensacove (ensartinib)

11d

A single-arm, multicenter clinical study of ensartinib combined with chemotherapy as neoadjuvant therapy for ALK-positive non-small cell lung cancer (NSCLC) (TD-ENSEMBLE study) (ChiCTR2500113689)

P4, N=20, Not yet recruiting, The Second Affiliated Hospital of Air Force Medical University; The Second Affiliated Hospital of Air Force Medical University

11 days ago

New P4 trial

ALK (Anaplastic lymphoma kinase)

ALK fusion • ALK mutation

Ensacove (ensartinib)

11d

SHR-A1811 plus QL1706 versus standard therapy as first-line treatment for locally advanced or metastatic HER2-overexpressing non-small cell lung cancer: an open-label, single-arm, phase II clinical trial (ChiCTR2500114106)

P2, N=39, Not yet recruiting, Shanghai Pulmonary Hospital; Shanghai Pulmonary Hospital

11 days ago

New P2 trial

EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)

HER-2 positive • EGFR mutation • HER-2 overexpression • HER-2 mutation • ALK mutation • HER-2 positive + HER-2 overexpression

trastuzumab rezetecan (SHR-A1811) • Qibeian (iparomlimab/tuvonralimab)