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

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

Metastatic Malignant Mesothelioma of the Tunica Vaginalis Testis Treated With Sequential Immunotherapy, Chemotherapy, and Radiotherapy With Prolonged Disease Stabilisation: A Case Report. (PubMed, Cureus) - "The patient received first-line immunotherapy with ipilimumab and nivolumab but experienced progressive nodal disease. Second-line carboplatin-pemetrexed chemotherapy resulted in a mixed radiological response after three cycles, with para-aortic nodal oligoprogression managed using palliative radiotherapy...Subsequent progression involved pulmonary and intra-abdominal nodal disease, prompting initiation of third-line oral vinorelbine...Approximately four years after diagnosis, the patient remained clinically stable, with an Eastern Cooperative Oncology Group (ECOG) performance status of 1, and was awaiting interval imaging to assess radiological disease status. This case illustrates that an individualised sequential treatment strategy incorporating immunotherapy, chemotherapy, and palliative radiotherapy to sites of oligoprogression may be associated with periods of disease control in metastatic malignant mesothelioma of the tunica vaginalis testis."

Journal • Mesothelioma • Oncology • Solid Tumor

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

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 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

An Open-label, Two-Cohort, Phase II Study Evaluating Efficacy and Safety of NLX + NVB-Based Regimens in HER2-Positive MBC (ChiCTR) - P4 | N=321 | Not yet recruiting | Sponsor: Shanghai GoBroad Cancer Hospital; Shanghai GoBroad Cancer Hospital

New P4 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Prognostic Value of Serial Ultrasensitive ctDNA Analysis in Elderly NSCLC Undergoing Metronomic Vinorelbine and Immunotherapy (IASLC-WCLC 2026) - P4 | "This phase II study (ChiCTR2300074586) evaluated metronomic oral vinorelbine (mOV) plus PD-1 inhibitors as first-line treatment in patients aged ≥70 years with locally advanced or metastatic NSCLC without driver mutations...Us-ctDNA dynamics predict outcomes and aid in identifying pseudoprogression, tumor heterogeneity, and early progression. ( Research Sponsor: National High-Level Hospital Clinical Research Funding (BJ-2023-073))"

Circulating tumor DNA • Clinical • IO biomarker • Immune Modulation • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR • ROS1

First-Line Oral Vinorelbine Plus Furmonertinib in Refractory EGFR-mutated NSCLC: Safety Run-In Data From a Two-Cohort Study (IASLC-WCLC 2026) - P4 | "Although combinations of EGFR-TKIs with chemotherapy or amivantamab significantly improve both PFS and overall survival (OS) versus EGFR-TKI monotherapy, their clinical applicability is limited by increased toxicity and the requirement for intravenous administration. Conclusions : The all-oral combination of vinorelbine plus furmonertinib as first-line treatment was well tolerated and showed preliminary antitumor activity in EGFR -mutated locally advanced or metastatic NSCLC with M1c2 disease or elevated PD-L1 expression. More clinical data will be updated from this ongoing study."

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

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

ARST2031: A Study to Compare Early Use of Vinorelbine and Maintenance Therapy for Patients With High Risk Rhabdomyosarcoma (clinicaltrials.gov) - P3 | N=113 | Active, not recruiting | Sponsor: Children's Oncology Group | Trial completion date: Jun 2026 ➔ Jul 2027

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

The VIVA Regimen (Vinorelbine, Ifosfamide, Vincristine, and Actinomycin-D) for High-Risk Rhabdomyosarcoma: Feasibility and Outcomes From a Single-Institution Study. (PubMed, Pediatr Blood Cancer) - "Integrating vinorelbine into the intensive induction phase proved feasible with an acceptable toxicity profile and high response rates. Further investigations are needed to define the long-term efficacy of this promising intensive regimen."

Journal • Hematological Disorders • Neutropenia • Oncology • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor • Thrombocytopenia

Oral Vinorelbine in combination with Pertuzumab and Trastuzumab Injection (Subcutaneous Injection) as Neoadjuvant Therapy for HER2 Positive Early or Locally Advanced Breast Cancer: An open-label, single-arm study (ChiCTR) - P=N/A | N=82 | Not yet recruiting | Sponsor: Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Sun Yat-sen Memorial Hospital, Sun Yat-sen University

New trial • Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Efficacy and safety of metronomic oral vinorelbine in elderly patients with locally advanced and metastatic non-small cell lung cancer. (PubMed, BMC Cancer) - "Conclusion Metronomic OV demonstrated clinical efficacy in elderly patients with advanced wild-type NSCLC. It was associated with a significant reduction in toxicity and may represent a valuable therapeutic option for this age group, with excellent treatment compliance."

IO biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • ALK • EGFR • PD-L1 • ROS1

Performance status 2 or higher in EMA labels for advanced non-small-cell lung cancer: a cross-sectional SmPC analysis. (PubMed, Cancer Treat Res Commun) - "EU NSCLC labels seldom address ECOG PS ≥2 and rarely use PS for dose selection. Poor-PS treatment extrapolates from ECOG PS 0-1 evidence, supporting PS-inclusive trials and more standardised PS reporting in future SmPCs."

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

VINOREAL: To Describe How Well Vinorelbine Given Orally Works in Patients With a Breast Cancer After 2 Years of Treatment (clinicaltrials.gov) - P=N/A | N=368 | Active, not recruiting | Sponsor: Pierre Fabre Medicament | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2028 ➔ Sep 2028 | Trial primary completion date: Feb 2028 ➔ Sep 2028

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor

Efficacy and safety of first-line oral vinorelbine plus firmonertinib in refractory EGFR-mutated non-small cell lung cancer: study protocol of a multicenter, non-randomized, two-cohort study. (PubMed, Ther Adv Med Oncol) - P4 | "To the best of our knowledge, this study represents the first evaluation of vinorelbine plus firmonertinib in EGFR-mutated locally advanced or metastatic NSCLC with M1c2 disease or elevated PD-L1 expression, aiming to provide an effective, tolerable, and convenient all-oral treatment option for this refractory population. The study protocol (version 1.2; July 18, 2025) was registered on October 24, 2025, at the Chinese Clinical Trial Registry (ChiCTR2500111096)."

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

Evaluating the Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With VEX Metronomic Chemotherapy and Concurrent or Delayed Radiotherapy in Patients With Advanced HER2-Negative Breast Cancer With Brain Metastasis (clinicaltrials.gov) - P2 | N=102 | Recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • HER-2

Updated efficacy and safety of first-line PD-1 inhibitors plus metronomic oral vinorelbine in elderly patients with advanced NSCLC. (ASCO 2026) - P4 | "PD-1 inhibitors combined with mOV as first-line therapy provided significant survival benefits and acceptable tolerability in elderly patients with driver gene–negative metastatic NSCLC, particularly those with high PD-L1 expression. Similar efficacy and safety were observed in patients aged ≥80 years. Research Sponsor: National High-Level Hospital Clinical Research Funding (BJ-2023-073) and Beijing Medical Award Foundation Grant (YXJL-2020-0785-0251)."

Clinical • IO biomarker • Metastases • Gastrointestinal Disorder • Hepatology • Immunology • Lung Cancer • Myositis • Non Small Cell Lung Cancer • Pneumonia • Solid Tumor • ALK • EGFR • PD-L1 • ROS1

Oral Vinorelbine or Capecitabine Combined With Trastuzumab as Adjuvant Treatment for Patients With Lymph Node Negative, HER-2 Positive and Small Tumor Size Breast Cancer (ORCHID) (clinicaltrials.gov) - P2 | N=182 | Completed | Sponsor: Fudan University | Trial completion date: Jun 2027 ➔ Apr 2026 | Trial primary completion date: Jul 2025 ➔ Apr 2026 | Active, not recruiting ➔ Completed

Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

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) - P2 | "Background: TUC in combination with T and capecitabine is approved for the treatment HER2+ MBC pts who have received two prior anti-HER2 regimens...In the metastatic setting all pts received prior anti-HER2 therapy (92% T-DXd, 77% T-DM1), 92% received taxanes and 54% aromatase inhibitors... The combination of TUC, T and oral VNR is not recommended due to its higher-than-expected TEAE rates (particularly neutropenia) and lower than expected ORR."

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

Almonertinib Plus Oral Vinorelbine as First-line Treatment for EGFR-sensitive Mutation-positive Advanced Non-small Cell Lung Cancer with Performance Status 2-4: A Prospective, Multicenter, Single-arm, Phase II Clinical Study (ChiCTR) - P2 | N=62 | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University

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

Efficacy, safety, and protein markers of PD-1 inhibitors plus metronomic oral vinorelbine in elderly metastatic non-small-cell lung cancer patients (AACR 2025) - "The combination of PD-1 inhibitors plus mOV has good efficacy and safety in the postoperative treatment of elderly patients. Protein biomarkers can help accurately identify the patients that will benefit from this treatment regimen."

Clinical • IO biomarker • Late-breaking abstract • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1 • SH2D2A

IMMUNOLIFE2: Oral Pooled Fecal Microbiotherapy (MaaT033) Concomitant to Cemiplimab Versus Best Investigator's Choice in Patients With Resistance to Treatment Due to Antibiotics Uptake With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=162 | Recruiting | Sponsor: Gustave Roussy, Cancer Campus, Grand Paris | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous 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