^
6d
Enrollment closed
|
nintedanib
13d
Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis (clinicaltrials.gov)
P2, N=33, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jul 2025 --> Apr 2024 | Trial primary completion date: Jul 2025 --> Apr 2024
Trial completion • Trial completion date • Trial primary completion date
|
prednisone • nintedanib
19d
Trial completion
|
nintedanib
2ms
Aberrant TIMP-1 production in tumor-associated fibroblasts drives the selective benefits of nintedanib in lung adenocarcinoma. (PubMed, Cancer Sci)
We further pinpoint reduced SMAD3 expression and consequent limited TIMP-1 production in SCC-TAFs as key for the resistance of SCC to nintedanib. These observations strongly support the emerging role of TIMP-1 as a critical regulator of therapy response in solid tumors.
Journal
|
TIMP1 (Tissue inhibitor of metalloproteinases 1) • SMAD3 (SMAD Family Member 3)
|
nintedanib
2ms
Glasgow prognostic score and body mass index predict short-term discontinuation of the antifibrotic agents pirfenidone and nintedanib. (PubMed, Respir Investig)
GPS and BMI were significant factors for short-term pirfenidone and nintedanib discontinuation, respectively. Initial evaluation of GPS and BMI prior to antifibrotic therapy may contribute to less interrupted IPF management, thus leading to better prognostic outcomes in patients with IPF.
Journal
|
CRP (C-reactive protein)
|
nintedanib
2ms
Proteomic study on nintedanib in gastric cancer cells. (PubMed, PeerJ)
Nintedanib inhibits the proliferation, invasion, and metastasis of gastric cancer cells. The crossover pathways and protein networks predicted by proteomics should provide more detailed molecular information enabling the use of nintedanib against gastric cancer.
Journal
|
IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • ACOX1 (Acyl-CoA Oxidase 1)
|
nintedanib
2ms
NINBOST2018: Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation (clinicaltrials.gov)
P2, N=20, Recruiting, University Hospital, Basel, Switzerland | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025
Trial completion date • Trial primary completion date
|
nintedanib
3ms
Single‑agent nintedanib suppresses metastatic osteosarcoma growth by inhibiting tumor vascular formation. (PubMed, Oncol Lett)
In addition, nintedanib exhibited an anti-osteosarcoma effect on C57BL/6 severe combined immunodeficient mice in which T- and B-cell function is obsolete, suggesting that the antitumor effect of nintedanib was not attributable to antitumor immunity. Collectively, these findings indicated that nintedanib holds potential for treating osteosarcoma.
Journal • Metastases
|
FGFR (Fibroblast Growth Factor Receptor) • CD31 (Platelet and endothelial cell adhesion molecule 1) • PECAM1 (Platelet And Endothelial Cell Adhesion Molecule 1)
|
nintedanib
3ms
Trial completion
|
PD-L1 (Programmed death ligand 1)
|
Opdivo (nivolumab) • nintedanib
3ms
Inhibitor of PD-1/PD-L1: a new approach may be beneficial for the treatment of idiopathic pulmonary fibrosis. (PubMed, J Transl Med)
The use of the antifibrotic drugs pirfenidone and nintedanib can slow the progression of the disease to some extent, but it does not have a reverse effect on the prognosis. While current studies have focused on PD-1/PD-L1 and CTLA-4, PD-1/PD-L1 may be the only effective immune checkpoint IPF treatment. This review discusses the application of PD-1/PD-L1 checkpoint in IPF, with the aim of finding a new direction for IPF treatment.
Review • Journal
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
nintedanib
3ms
Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
P2, N=20, Active, not recruiting, Washington University School of Medicine | Trial completion date: Dec 2023 --> Dec 2024
Trial completion date • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • FLT1 (Fms-related tyrosine kinase 1)
|
EGFR mutation • ALK rearrangement • RET rearrangement • FGFR1 fusion
|
nintedanib
3ms
Enrollment closed
|
nintedanib
4ms
New trial • Real-world evidence • Real-world
|
nintedanib
4ms
PORTRAY: Safety of Nintedanib in Real World in China (clinicaltrials.gov)
P=N/A, N=0, Withdrawn, Boehringer Ingelheim | N=800 --> 0 | Not yet recruiting --> Withdrawn
Enrollment change • Trial withdrawal • Real-world evidence • Real-world
|
nintedanib
4ms
Nintedanib could potentially lead to improvements in anti-melanoma differentiation-associated 5 dermatomyositis-associated interstitial lung disease. (PubMed, Clin Exp Rheumatol)
Nintedanib may be effective for improving clinical symptoms, laboratory parameters, lung lesions, and survival in anti-MDA5+ DM. Diarrhoea was the most common adverse event associated with nintedanib, although the drug was well tolerated by most patients.
Journal
|
IFIH1 (Interferon Induced With Helicase C Domain 1)
|
nintedanib
4ms
Trial completion
|
nintedanib
4ms
Nintedanib and Azacitidine in Treating Participants With HOX Gene Overexpression Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
P1, N=44, Active, not recruiting, Northwestern University | Recruiting --> Active, not recruiting | Trial completion date: Jan 2024 --> Jan 2027 | Trial primary completion date: Mar 2023 --> Dec 2025
Enrollment closed • Trial completion date • Trial primary completion date
|
FLT3 (Fms-related tyrosine kinase 3) • KMT2A (Lysine Methyltransferase 2A) • CD34 (CD34 molecule) • HOXA9 (Homeobox A9) • FGF2 (Fibroblast Growth Factor 2)
|
HOXA9 overexpression
|
azacitidine • nintedanib
4ms
Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer (clinicaltrials.gov)
P1/2, N=68, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2023 --> Nov 2024
Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase)
|
BRAF V600E • EGFR mutation • BRAF V600 • EGFR T790M • ALK rearrangement • ROS1 rearrangement
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • nintedanib
5ms
PD-L1 overexpression induces STAT signaling and promotes the secretion of pro-angiogenic cytokines in non-small cell lung cancer (NSCLC). (PubMed, Lung Cancer)
In this study, we reported that high PD-L1 modulates STAT signaling in the presence of PBMC and induces pro-angiogenic factor secretion. This could enforce the role of PD-L1 as a crucial regulator of the tumor microenvironment stimulating tumor progression, both as an inhibitor of T-cell activity and as a promoter of tumor angiogenesis.
Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CD31 (Platelet and endothelial cell adhesion molecule 1) • PECAM1 (Platelet And Endothelial Cell Adhesion Molecule 1)
|
PD-L1 overexpression
|
nintedanib
5ms
A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON) (clinicaltrials.gov)
P3, N=60, Recruiting, Boehringer Ingelheim | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
Trial completion date • Trial primary completion date
|
nintedanib
5ms
VARGADO - Vargatef in 2nd-line Therapy of Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
P=N/A, N=816, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting
Enrollment closed
|
docetaxel • nintedanib
5ms
Cost in the United States of FDA-approved small molecule protein kinase inhibitors used in the treatment of neoplastic and non-neoplastic diseases. (PubMed, Pharmacol Res)
The average monthly cost for the treatment of neoplastic diseases was $17,900 with a price of $44,000 for futibatinib (used to treat cholangiocarcinomas with FGFR2 fusions) and minimum of $5100 for binimetinib (melanoma). The average monthly cost for the treatment of non-neoplastic diseases was $6800 with a maximum of $17,000 for belumosudil (graft vs. host disease) and a minimum of $200 for netarsudil eye drops (glaucoma). There is a negative correlation of the cost of the drugs and the incidence of the targeted disease. Many of these agents are or were designated as orphan drugs meaning that there are fewer than 200,000 potential patients in the United States.
FDA event • Review • Journal
|
FGFR2 (Fibroblast growth factor receptor 2)
|
FGFR2 fusion
|
Tagrisso (osimertinib) • Imbruvica (ibrutinib) • imatinib • lapatinib • Mektovi (binimetinib) • Lytgobi (futibatinib) • Tukysa (tucatinib) • nintedanib • Ayvakit (avapritinib) • Inrebic (fedratinib) • Tavalisse (fostamatinib)
5ms
A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood (clinicaltrials.gov)
P1, N=14, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting
Enrollment closed
|
nintedanib
5ms
Trial completion date • Trial primary completion date • HEOR • Real-world evidence • Real-world
|
nintedanib
5ms
All-Case Surveillance of Ofev in Patients With IPF in Japan (clinicaltrials.gov)
P=N/A, N=10117, Completed, Boehringer Ingelheim | Recruiting --> Completed | N=6000 --> 10117 | Trial completion date: Nov 2023 --> May 2023 | Trial primary completion date: Nov 2023 --> May 2023
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
|
nintedanib
6ms
Preclinical
|
EGFR (Epidermal growth factor receptor)
|
Tagrisso (osimertinib) • nintedanib
6ms
Enrollment open
|
nintedanib
6ms
Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan (clinicaltrials.gov)
P=N/A, N=550, Recruiting, Boehringer Ingelheim | Trial completion date: Mar 2026 --> Sep 2026 | Trial primary completion date: Dec 2025 --> Jun 2026
Trial completion date • Trial primary completion date
|
nintedanib
6ms
A Mechanical Conditioning gene expression (MeCo) score detects the patients that benefit from neoadjuvant anti-fibrotic therapy in early HER2-negative breast cancer (HER2negBC). (SABCS 2023)
Among early HER2negBC, Luminal B cases display the highest MeCo Scores. MeCo Score was independent of all classic prognostic variables. High MeCo Score is associated with lack of pCR to neoadjuvant paclitaxel monotherapy, but concurrent administration of the anti-fibrotic agent nintedanib rescues this association.
Clinical
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • FGFR1 (Fibroblast growth factor receptor 1) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • FLT1 (Fms-related tyrosine kinase 1)
|
HER-2 negative • PGR positive
|
Prosigna™ Breast Cancer Prognostic Gene Signature Assay
|
paclitaxel • nintedanib
7ms
Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients (clinicaltrials.gov)
P2, N=20, Not yet recruiting, China Medical University Hospital
New P2 trial
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR positive
|
erlotinib • Gilotrif (afatinib) • gefitinib • nintedanib
7ms
New P1 trial
|
nintedanib
7ms
Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
P2, N=20, Active, not recruiting, Washington University School of Medicine | Trial completion date: Jun 2023 --> Dec 2023
Trial completion date • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • FLT1 (Fms-related tyrosine kinase 1)
|
EGFR mutation • ALK rearrangement • RET rearrangement • FGFR1 fusion
|
nintedanib
7ms
Impact of KRAS status on the efficacy of nintedanib + docetaxel following treatment with first-line immune checkpoint inhibitor + chemotherapy in patients with adenocarcinoma NSCLC: analysis of cohort C of the non-interventional VARGADO trial (DGHO 2023)
Brain metastases were present in 19.9% (47/236) of pts and 86.4% (204/236) had received prior 1L pembrolizumab-based combination therapy. NIN + DOC is an effective and safe 2L treatment option after prior 1L ICI + chemotherapy for NSCLC adenocarcinoma pts independent of KRAS status.
Clinical • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS wild-type • RAS wild-type • KRAS G12
|
Keytruda (pembrolizumab) • docetaxel • nintedanib
7ms
The tyrosine kinase inhibitor nintedanib enhances the efficacy of 90Y-labeled B5209B radioimmunotherapy targeting ROBO1 without increased toxicity in small-cell lung cancer xenograft mice. (PubMed, Nucl Med Commun)
Nintedanib significantly enhanced the anti-tumor effects of RIT with the 90Y-B5209B without an increase in toxicity. These findings encourage further research into the potential clinical application of combining RIT with nintedanib.
Preclinical • Journal
|
ROBO1 (Roundabout Guidance Receptor 1)
|
nintedanib
8ms
Personalized Biomarker-Based Umbrella Trial for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: KCSG HN 15-16 TRIUMPH Trial. (PubMed, J Clin Oncol)
To our knowledge, this study is the first biomarker-driven umbrella trial for platinum-refractory HNSCC using matched molecular targeted agents. We found that NGS-based genomic phenotyping was methodologically feasible and applicable.
Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
|
EGFR (Epidermal growth factor receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • FGFR (Fibroblast Growth Factor Receptor)
|
Imfinzi (durvalumab) • Piqray (alpelisib) • Imjudo (tremelimumab) • nintedanib • Pozenveo (poziotinib)
8ms
Efficacy and safety of nintedanib and docetaxel in patients with previously treated lung non-squamous non-small cell lung cancer: a multicenter retrospective real-world analysis. (PubMed, Radiol Oncol)
The combination of docetaxel and nintedanib can be considered an effective therapy option with an acceptable toxicity profile for patients with advanced NSCLC after the failure of ICI +/- ChT.
Retrospective data • Journal • Real-world evidence • Real-world
|
docetaxel • nintedanib
8ms
Efficacy and safety of nintedanib in patients with non-small cell lung cancer, and novel insights in radiation-induced lung toxicity. (PubMed, Front Oncol)
Recently, several clinical trials of nintedanib to treat NSCLC have been reported. In this review, we focus on our current understanding of nintedanib treatment for advanced NSCLC patients and summarize the literature on using nintedanib in radiation-induced lung toxicity and the efficacy and tolerability of nintedanib.
Review • Journal
|
nintedanib
9ms
GIST-BSF1: A NOVEL SCF-DEPENDENT, WILD-TYPE KIT CELL LINE PLATFORM THAT ALLOWS RAPID GENERATION OF ISOGENIC SUBLINES WITH BOTH IMATINIB-SENSITIVE AND IMATINIB-RESISTANT GENOTYPES (CTOS 2023)
In comparison to parental GIST-T1, GIST-BSF1 treated with SCF displayed 4.3-29.3-fold higher GR50-values for all tested KIT inhibitors, except for sunitinib (1.4-fold) and nintedanib (3.1-fold)...GIST-BSF1 sublines with secondary mutations in-cis in both the ATP binding pocket (AP) and activation loop (AL) of KIT, called AP/AL mutations, display the same inhibitory profile towards ripretinib as seen in AP/AL mutations previously modelled in GIST-T1 (GR50 values for AP/AL mutants >20-fold higher than corresponding AL mutants)... GIST-BSF1 is the first KIT-WT, SCF-dependent GIST cell line, which allows study of the impact of KIT inhibitors on WT KIT. Reintroduction of KIT mutations leads to SCF-independent growth and yielded anticipated TKI profiles. This cell line platform allows the rapid validation of novel variants of KIT and other oncogenic kinases in a GIST-specific cellular background.
Preclinical
|
PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • NF1 (Neurofibromin 1) • IL4 (Interleukin 4)
|
PIK3CA mutation • PTEN mutation • KIT mutation • PDGFRA mutation • TERT mutation • KIT wild-type
|
imatinib • Sutent (sunitinib) • nintedanib • Qinlock (ripretinib)
9ms
Management of patients with idiopathic pulmonary fibrosis and lung cancer: challenges in clinical practice. (PubMed, Curr Opin Pulm Med)
Lung cancer is prevalent in IPF. Management of patients with IPF and lung cancer is challenging. A consensus statement aiming to attenuate confusion is greatly anticipated.
Journal
|
carboplatin • albumin-bound paclitaxel • nintedanib