Chemotherapy Plus Pitavastatin Guided by Patient-Derived Tumor-like Cell Clusters in Refractory Non-Small Cell Lung Cancer

The primary objective of this study is to evaluate the objective response rate (ORR = CR + PR) of pitavastatin combined with chemotherapy, guided by PTC (patient-derived tumor-like cell cluster) drug sensitivity, in patients resistant to second-line treatment (PD/SD). The ORR is defined as the proportion of patients achieving a response after four cycles of combination therapy. The main questions it aims to answer are: 1. Does PTC-guided medication is feasible 2. Does the administration of Pitavastatin combined with chemotherapy can improve the objective response rate (ORR) in second-line drug-resistant patients The medication to participants will be strictly guided by PTC drug testing. The drugs examined in this study included chemotherapy agents such as cisplatin for injection, carboplatin for injection, pemetrexed disodium for injection, paclitaxel injection, gemcitabine hydrochloride for injection, and docetaxel injection, as well as pitavastatin. The selection of chemotherapy drugs was based on the results of PTC drug sensitivity testing, with combination therapy showing the highest sensitivity. Drug dosages were administered according to the recommended standards outlined in the guidelines (every three weeks, intravenous). Treatment continued until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of treatment for other reasons specified in the protocol, whichever occurred first. Pirvastatin is administered orally by the subjects themselves at a fixed time each morning (4 mg, once daily), with or without food, until disease progression or intolerance occurs. Participants must demonstrate good compliance throughout the entire study, especially when the dosage is reduced, to ensure they receive the correct prescribed dose.

NCT Number	NCT07351565
Lead Sponsor	Chang Chen
Conditions	Non-Small Cell Lung Cancer
Enrollment	22 participants
Start Date	2026-01-10
Primary Completion	2026-06-30 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-20