Navelbine oral (vinorelbine tartrate oral) / Pierre Fabre - LARVOL DELTA

ECOG performance status 2 or higher in EMA labels for advanced non-small cell lung cancer: A cross-sectional analysis of EU SmPCs (ELCC 2026) - "Gemcitabine was the only product explicitly permitting monotherapy in PS 2 (1/41, 2.4%). Atezolizumab met label-anchored criteria via a platinum-ineligible population enriched for PS 2–3, yielding 2/41 (4.9%) with any label-level eligibility signal for PS ≥2...PS-linked dose guidance was uncommon: carboplatin included ECOG-defined initial dose reduction and oral vinorelbine included qualitative poor-PS starting-dose/escalation guidance (2/41, 4.9%); all others had none.Conclusions EU NSCLC SmPCs rarely operationalise ECOG PS ≥2 for eligibility or dosing, and PS reporting in Section 5.1 is inconsistent. PS-inclusive trials and standardised PS reporting could improve interpretability of EU labels and support more consistent treatment decisions."

Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First-line atezolizumab monotherapy versus single-agent chemotherapy in patients with non-small-cell lung cancer ineligible for treatment with a platinum-containing regimen (IPSOS): a phase 3, global, multicentre, open-label, randomised controlled study. (PubMed, Lancet) - P3 | "First-line treatment with atezolizumab monotherapy was associated with improved overall survival, a doubling of the 2-year survival rate, maintenance of quality of life, and a favourable safety profile compared with single-agent chemotherapy. These data support atezolizumab monotherapy as a potential first-line treatment option for patients with advanced NSCLC who are ineligible for platinum-based chemotherapy."

Journal • Monotherapy • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A prospective, multicenter phase II study of ctDNA-guided Individualized therapy with aumolertinib ± chemotherapy in advanced L858R EGFR+ NSCLC (ELCC 2026) - "Patients will receive induction therapy with aumolertinib (110 mg once daily) combined with platinum-based chemotherapy (pemetrexed plus cisplatinum or carboplatin) for 4 to 6 cycles...Patients achieving ctDNA clearance will transition to aumolertinib monotherapy, while those with ctDNA persistent positive will continue with aumolertinib plus oral vinorelbine 40mg three times weekly (Monday-Wednesday-Friday)...EGFR L858R mutation and positive ctDNA are critical clinical indicators of poor prognosis. By ctDNA dynamic monitoring as a potential prognostic biomarker, this study aims to address two clinical questions, the necessity of initial intensive therapy for high-risk patients and the feasibility of transitioning to metronomic chemotherapy regimen during maintenance to balance efficacy and tolerability, and how to dynamically adjust treatment strategies (intensification or de-escalation) based on ctDNA status to achieve precision therapy."

Circulating tumor DNA • Clinical • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

First-line oral vinorelbine plus furmonertinib in refractory epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC): A multicenter, non-randomized, two-cohort study (ELCC 2026) - P4 | "Primary endpoint is investigator-assessed PFS. Secondary endpoints are objective response rate, disease control rate, OS, and safety."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PD-L1

MOVIE: Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=150 | Active, not recruiting | Sponsor: UNICANCER | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2021 ➔ Jan 2022

Enrollment closed • Pan tumor • Trial primary completion date • Tumor mutational burden • Breast Cancer • Cervical Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • TMB

MOVIE: Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=150 | Active, not recruiting | Sponsor: UNICANCER | Trial primary completion date: Jan 2022 ➔ May 2022

Pan tumor • Trial primary completion date • Tumor mutational burden • Breast Cancer • Cervical Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • TMB

MOVIE: Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=126 | Completed | Sponsor: UNICANCER | Active, not recruiting ➔ Completed

Pan tumor • Trial completion • Tumor mutational burden • Breast Cancer • Cervical Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • TMB

MOVIE: Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: UNICANCER | Suspended ➔ Recruiting | Trial completion date: Aug 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2020 ➔ Jun 2021

Enrollment open • Pan tumor • Trial completion date • Trial primary completion date • Tumor mutational burden • Breast Cancer • Cervical Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • TMB

MOVIE: Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=150 | Not yet recruiting | Sponsor: UNICANCER

New P1/2 trial • Pan tumor • Tumor mutational burden • Breast Cancer • Cervical Cancer • Hormone Receptor Positive Breast Cancer • Prostate Cancer • Squamous Cell Carcinoma of Head and Neck • TMB

MOVIE: Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: UNICANCER | Not yet recruiting ➔ Recruiting

Enrollment open • Pan tumor • Tumor mutational burden • Breast Cancer • Cervical Cancer • Hormone Receptor Positive Breast Cancer • Prostate Cancer • Squamous Cell Carcinoma of Head and Neck • TMB

MOVIE: Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=150 | Suspended | Sponsor: UNICANCER | Recruiting ➔ Suspended

Pan tumor • Trial suspension • Tumor mutational burden • Breast Cancer • Cervical Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Oncology • Prostate Cancer • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • TMB

Efficacy and Safety of the combination of Trastuzumab (T), Tucatinib (TUC), and oral Vinorelbine (VNR) in patients (pts) with HER2+ Metastatic Breast Cancer (MBC): Results from the TrasTUCAN (GEICAM/2020-08) Phase II Study (ESMO-BC 2026) - No abstract available

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

ARST2031: A Study to Compare Early Use of Vinorelbine and Maintenance Therapy for Patients With High Risk Rhabdomyosarcoma (clinicaltrials.gov) - P3 | N=118 | Active, not recruiting | Sponsor: Children's Oncology Group | Trial completion date: Sep 2027 ➔ Jun 2026 | Trial primary completion date: Sep 2027 ➔ Jun 2026

Trial completion date • Trial primary completion date • Oncology • Rhabdomyosarcoma • Sarcoma • Solid Tumor • Spindle Cell Sarcoma • FOXO1

The NARLAL II trial: First results on loco-regional control in stage 3 NSCLC (ESTRO 2024) - P=N/A | "Background The survival and loco-regional control for patients with locally advanced NSCLC (LA-NSCLC) are dismal despite the introduction of adjuvant durvalumab...S118 Invited Speaker Concomitant chemotherapy was oral Navelbine®50 mg three times a week and cisplatin or carboplatin administered at weeks one and four...Dose escalation was determined safe in the pre-planned interim analyses. We are looking forward to present the data on the primary end point."

Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

A direct comparison of classical oral Navelbine vs metronomic Navelbine in metastatic breast cancer: results from the Danish Breast Cancer Group's (DBCG) NAME-trial. (PubMed, Breast Cancer Res Treat) - P2 | "Our overall evaluation of the NAME-trial results showed that metronomic oral Navelbine is not superior to the standard treatment with Vinorelbine and without any significant differences concerning side effects."

Journal • Breast Cancer • Oncology • Solid Tumor

A randomized phase II trial of metronomic oral vinorelbine plus cyclophosphamide and capecitabine (VEX) vs weekly paclitaxel (P) as first- or second-line treatment in patients (pts) with ER+/HER2- metastatic breast cancer (MBC): The METEORA-II trial (IBCSG 54-16) (ESMO 2022) - P2 | "Three pts died during treatment (1 P; 2 VEX). Conclusions METEORA-II trial showed VEX significantly improved TTF compared with P. VEX metronomic oral treatment should be considered as a first-line CT regimen for pts with ER+/HER2- MBC that require CT."

Clinical • P2 data • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Efficacy of Metronomic Oral Vinorelbine, Cyclophosphamide, and Capecitabine vs Weekly Intravenous Paclitaxel in Patients With Estrogen Receptor-Positive, ERBB2-Negative Metastatic Breast Cancer: Final Results From the Phase 2 METEORA-II Randomized Clinical Trial. (PubMed, JAMA Oncol) - P2 | "The VEX regimen may provide more prolonged disease control than weekly paclitaxel for ER+/ERBB2- MBC. ClinicalTrials.gov Identifier: NCT02954055."

Clinical • Journal • Metastases • P2 data • Alopecia • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • TYK2

Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer (clinicaltrials.gov) - P2 | N=24 | Active, not recruiting | Sponsor: University of Miami | Recruiting ➔ Active, not recruiting | N=500 ➔ 24

Biomarker • Circulating tumor DNA • Enrollment change • Enrollment closed • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Efficacy and safety of oral vinorelbine with concurrent radiotherapy in unresectable stage III non-small cell lung cancer following neoadjuvant chemoimmunotherapy: a single-arm, phase 2 trial. (PubMed, J Natl Cancer Cent) - P2 | "In individuals with unresectable stage Ⅲ NSCLC who had received NACIT and were not candidates for concurrent intravenous chemotherapy with RT, the oral vinorelbine plus concurrent RT demonstrated promising antitumor efficacy with acceptable toxicity profiles. ClinicalTrials.gov (NCT06540950)."

Journal • P2 data • Gastrointestinal Disorder • Hematological Disorders • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pneumonia • Solid Tumor

Update on pediatric soft tissue sarcomas. (PubMed, Curr Opin Pediatr) - "Pediatric STS are rare and biologically heterogeneous. Genomic advances have refined risk stratification and uncovered therapeutic targets; further progress relies on international collaboration and trials."

IO biomarker • Journal • Review • Alveolar Soft Tissue Sarcoma • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma • FOXO1 • MYOD1 • NTRK • TP53

Ultrasensitive ctDNA dynamics predict clinical outcomes in elderly NSCLC patients treated with metronomic vinorelbine and immunotherapy (ESMO Asia 2025) - P4 | "A phase II trial (ChiCTR2300074586) addressed this gap by evaluating metronomic oral vinorelbine (mOV) plus PD-1 inhibitors as first-line therapy for patients ≥70 years with local advanced or metastatic NSCLC lacking driver mutations. Elderly NSCLC pts received mOV plus immunotherapy as the first-line therapy and serial plasma samples underwent tumor-naive MRD monitoring strategy (218 genes, 30,000X ultra-depth, Kanghui Biotech... mOV plus PD-1 inhibitor as the first-line therapy demonstrates significant efficacy and manageable toxicity in elderly NSCLC. Ultrasensitive ctDNA dynamics powerfully predict survival outcomes and may offer a potential approach to distinguish pseudoprogression."

Circulating tumor DNA • Clinical • Clinical data • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Evolutionary Therapy for Rhabdomyosarcoma (clinicaltrials.gov) - P2 | N=12 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Recruiting ➔ Active, not recruiting | N=28 ➔ 12

Enrollment change • Enrollment closed • Oncology • Rhabdomyosarcoma • Sarcoma • Solid Tumor • FOXO1

MOVIE phase II trial of tremelimumab plus durvalumab combined with metronomic oral vinorelbine in patients with head and neck cancer. (PubMed, ESMO Open) - "Metronomic vinorelbine in combination with dual durvalumab plus tremelimumab immunotherapy had only moderate activity in pretreated advanced HNSCC."

Journal • P2 data • Head and Neck Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A single-arm clinical study of subcutaneous injection of enolumab combined with oral vinorelbine as the first-line treatment for elderly patients with advanced non-small cell lung cancer (ChiCTR) - P2 | N=62 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Guangzhou Medical University; The First Affiliated Hospital of Guangzhou Medical University

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

15 years single center experience in the treatment of advanced non-small cell lung cancer with single agent oral metronomic vinorelbine in challenging clinical settings (ESMO 2025) - "Background Safety profile and high patient compliance make metronomic oral vinorelbine (mOV) a solid treatment option in various challenging clinical scenarios of advanced non-small cell lung cancer (aNSCLC)...No new safety issues were recorded after immunotherapy and EGFR-TKis. Legal entity responsible for the study The authors."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor