nintedanib

This is the first report of trametinib-nintedanib for a 57-year-old KRAS G12D-mutated recurrent pancreatic ductal adenocarcinoma. He had transient remission (lower CA19-9, stable lesions) but died of gastrointestinal bleeding, showing efficacy and bleeding risk.

These findings support the use of nintedanib in combination with radiotherapy as an effective, low-toxicity treatment strategy, highlighting the antitumor potential of ATF4-targeted agents.

P1, N=20, Not yet recruiting, Guangdong Hengrui Pharmaceutical Co., Ltd

All therapeutic agents-including the oncolytic adenovirus Ad5/3-D24-ICOSL-CD40L, cisplatin, paclitaxel, and nintedanib-were administered through flow-based circulation to more accurately replicate human pharmacokinetic conditions and tumor-drug interactions. This tumor-on-a-chip platform provides a physiologically relevant tool for real-time monitoring of treatment response, immune activation, and drug delivery under continuous flow. By bridging the gap between traditional in vitro models and in vivo studies, it offers a powerful preclinical system for optimizing combination regimens and advancing personalized therapies in ovarian cancer.

P1, N=132, Completed, Trevi Therapeutics | Recruiting --> Completed

This study highlights FGFR4, FLT1, and WNT5A as key diagnostic and therapeutic biomarkers for CRC, with their relevance varying based on the tumor's site of origin. Leveraging these findings, we propose Dovitinib and Nintedanib as promising targeted therapies for CRC. These insights can enhance current treatment strategies and pave the way for future in vivo and in vitro studies, driving progress in CRC research and therapy.

P=N/A, N=88, Terminated, Boehringer Ingelheim | Trial completion date: Dec 2026 --> Sep 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2026 --> Sep 2025; Company decision

The effectiveness of docetaxel, administered with or without antiangiogenic agents, was found to be limited in a real-world setting of non-small cell lung cancer (NSCLC) patients with a KRAS G12C mutation, emphasizing the need for novel therapies. Comprehensive molecular profiling remains crucial for optimizing treatment outcomes in this heterogeneous subgroup.

We retrospectively analyzed 61 patients from multiple Italian centers: 35 received antifibrotic therapy (pirfenidone or nintedanib) and 26 did not. In this heterogeneous real-world cohort, antifibrotic therapy was not associated with increased AE-ILD risk, and descriptive OS comparisons showed no clear survival advantage. These exploratory findings warrant confirmation in larger, prospective studies.

P2, N=37, Terminated, European Organisation for Research and Treatment of Cancer - EORTC | Active, not recruiting --> Terminated; lack of scientific relevance (change in the treatment landscape) and poor recruitment

Vertical inhibition of the RAS/MEK/ERK pathway by targeting SHP2 or SOS1 and the downstream kinases MEK (trametinib) or ERK (temuterkib) was highly effective. Inhibition of upstream tyrosine receptor kinases with nintedanib in combination with batoprotafib or BI-3406 was also effective, and in combination with sotorasib, demonstrated synergy in spheroids harboring KRAS G12C. Dual inhibition of the RAS/MEK/ERK and PI3K/AKT/mTOR pathways by batoprotafib or sotorasib with either the mTORC1/2 inhibitor sapanisertib or the AKT inhibitor ipatasertib demonstrated combination activity, primarily in spheroids harboring KRAS G12C. The BCL-2 inhibitor venetoclax in combination with sotorasib, batoprotafib or BI-3406 resulted in additive and synergistic cytotoxicity. Lastly, concurrent inhibition of the KRAS pathway with sotorasib and batoprotafib demonstrated combination activity in spheroids containing KRAS G12C.

P3, N=328, Not yet recruiting, Sun Yat-sen University