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

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

A Multicenter, Open Label, Dual Cohort Study: The Efficacy and Safety of Vinorelbine Combined With a First-Line Treatment for Metastatic NSCLC (IASLC-WCLC 2025) - "However, while contemporary first-line treatment paradigms have increasingly incorporated pemetrexed- or taxane-based regimens combined with immune checkpoint inhibitors (ICIs), clinical evidence supporting vinorelbine-based immunotherapy combinations remains scarce. The phase II VinMetAtezo trial provided preliminary insights, demonstrating that metronomic oral vinorelbine combined with atezolizumab, though failing to meet its primary PFS endpoint, maintained an acceptable safety profile with no new toxicity signals...The study design will be as follows: vinorelbine (60mg/m 2 d1, q3w) and cisplatin (75mg/m 2 d1, q3w) in combination with Sintilimab (200mg d1, q3w) with/without Bevacizumab (15mg/kg d1, q3w)...Secondary endpoints: efficacy, safety and quality of life. Exploratory endpoint: circulating tumor DNA dynamics and correlation with outcomes."

Clinical • IO biomarker • Metastases • Endocrine Cancer • Gastrointestinal Disorder • Human Immunodeficiency Virus • Immunology • Infectious Disease • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Renal Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

Efficacy and Safety of Oral Chemotherapy Concurrent Radiotherapy in Patients with Unresectable Stage III Non-Small Cell Lung Cancer after Neoadjuvant Chemoimmunotherapy (ASTRO 2025) - "In patients with unresectable stage III non-small cell lung cancer who had received neoadjuvant chemoimmunotherapy and were not candidates for concurrent intravenous chemotherapy with radiotherapy, the combination of oral vinorelbine and concurrent radiotherapy demonstrated promising antitumor efficacy with acceptable toxicity profiles."

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

Aumolertinib Combined With Metronomic Oral Vinorelbine in Advanced EGFR-Mutant NSCLC (IASLC-WCLC 2025) - "Conclusions : Aumolertinib plus metronomic oral vinorelbine has preliminarily shown superior efficacy and the combination therapy is well-tolerated. Enrollment will continue for further analyses."

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

Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET) (clinicaltrials.gov) - P3 | N=27 | Active, not recruiting | Sponsor: Spanish Breast Cancer Research Group | Trial primary completion date: Jun 2025 ➔ Jun 2026 | Trial completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR • PIK3CA

SYSKY-2023-1016-01: Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • BRCA

Tremelimumab plus durvalumab combined to metronomic oral vinorelbine: Results from the breast cancer cohort of the phase II MOVIE study. (PubMed, Breast) - P1/2 | "Metronomic vinorelbine and durvalumab plus tremelimumab showed limited antitumor activity in pretreated advanced BC. Alternative strategies are warranted to enhance the efficacy of ICI in those tumors."

Journal • P2 data • Breast Cancer • Fatigue • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer

A single-arm, single-center, phase II clinical study of ivorximab combined with metrometric chemotherapy in the treatment of advanced or metastatic squamous NSCLC after failure of second-line or more systemic therapy (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: Shandong First Medical University Affiliated Tumor Hospital; Shandong First Medical University Affiliated Tumor Hospital

New P2 trial • Lung Cancer • Lung Non-Small Cell Squamous 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 | Recruiting | Sponsor: Pierre Fabre Medicament | Not yet recruiting ➔ Recruiting | Trial primary completion date: Sep 2026 ➔ Feb 2028

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

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

Continuous Anlotinib Combined with Oral Vinorelbine has Shown Anti-Tumor Efficiency in Refractory HER2 Negative Advanced Breast Cancer. (PubMed, Breast Cancer (Dove Med Press)) - "The most common grade 3-4 AEs that we observed were neutropenia (17.1%), leukopenia (9.8%) and diarrhea (9.8%). Continuous administration of anlotinib combined with oral vinorelbine demonstrates to be efficacious and well tolerated for refractory HER2 negative ABC."

Journal • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • HER-2

Efficacy and safety of metronomic oral vinorelbine combined with PD-1 inhibitors as first-line therapy in advanced non-small-cell lung cancer in elderly patients. (ASCO 2025) - P4 | "The regimen of PD-1 inhibitors plus mOV as first-line therapy showed significant survival benefits and a favorable safety profile in elderly patients with driver-gene-negative metastatic NSCLC, particularly those with high PD-L1 expression."

Clinical • IO biomarker • Metastases • Gastrointestinal Disorder • Hepatology • Immune Modulation • Immunology • Infectious Disease • Lung Cancer • Myositis • Non Small Cell Lung Cancer • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • ALK • EGFR • ROS1

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 | Not yet recruiting | Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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

Impact of maintenance treatment on male gonadal function in patients treated for localized rhabdomyosarcoma in RMS2005 trial in France. (PubMed, Cancer) - "Oral-CPM induces additional gonadal damage to the ifosfamide-based induction regimen. Fertility preservation could be considered in patients exposed to maintenance, especially those >5 years old and exposed to ≥12 months of oral-CPM."

Clinical • Journal • Oncology • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease (clinicaltrials.gov) - P2 | N=135 | Recruiting | Sponsor: St. Jude Children's Research Hospital | Phase classification: P1/2 ➔ P2 | N=100 ➔ 135

Enrollment change • Phase classification • Oncology • Rhabdomyosarcoma • Sarcoma • Solid Tumor • FOXO1 • MYOD1 • TP53

Is the SOCCAR Regimen Now a Standard Treatment? (ESTRO 2025) - "Concurrent weekly carboplatin-taxol or oral vinorelbine-based chemotherapy was administered, with some patients receiving additional neoadjuvant chemotherapy using platinum-vinorelbine and/or nivolumab. The SOCCAR regimen, when combined with concurrent chemotherapy and/or neoadjuvant therapy, demonstrated promising clinical outcomes in terms of survival and local disease control for patients with locally advanced NSCLC. Importantly, the treatment was well tolerated, with manageable toxicity profiles. These findings support the ongoing use of this approach in clinical practice and highlight the need for further investigation to validate its efficacy and safety in larger patient populations."

Gastrointestinal Disorder • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Solid Tumor • Squamous Cell Carcinoma

Increased FDG Uptake on PET During Treatment for Rhabdomyosarcoma due to Maturing Rhabdomyoblasts (ASPHO 2025) - P3 | "He enrolled on COG-ARST2031 (NCT04994132) and randomized to Arm A with vincristine/dactinomycin/cyclophosphamide (VAC) and maintenance with vinorelbine/oral cyclophosphamide. Increased FDG uptake on PET surveillance for rhabdomyosarcoma may not represent disease progression and should be interpreted with caution. While PET scans are useful for staging, its role in disease surveillance is uncertain. Biopsy confirmation for suspected recurrence on PET/CT scan is encouraged."

Oncology • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Chemo-radiation involving Oral Vinorelbine in Lung Cancer: An Alternative Schedule for Elderly Patients (ESTRO 2025) - "Concomitant chemoradiotherapy founded on oral vinorelbine is shown as a via alternative for elderly patients with comorbidities, providing good control rates and excellent tolerance."

Clinical • Anemia • Cardiovascular • Chronic Obstructive Pulmonary Disease • Gastrointestinal Disorder • Heart Failure • Hematological Disorders • Immunology • Lung Cancer • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor

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

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=178 | Active, not recruiting | Sponsor: Fudan University | Unknown status ➔ Active, not recruiting | Trial completion date: May 2021 ➔ Jun 2027 | Trial primary completion date: May 2021 ➔ Jul 2025

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

Pooled analysis of oral vinorelbine as single agents in patients with advanced NSCLC. (PubMed, Lung Cancer Manag) - "The most reported grade ≥3 AEs were neutropenia (17.6%), fatigue (5.8%), and decreased appetite (4.9%). This pooled analysis showed that weekly oral VRN is a valid option, with an acceptable safety profile, in this population of patients with advanced NSCLC, confirming results from previous individual studies."

Journal • Retrospective data • Fatigue • Hematological Disorders • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor