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

NCT07351565 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-01-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Pitavastatin 1 mg daily or 4 mg daily

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.

Sponsors & Collaborators

  • Chang Chen

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-10
Primary Completion
2026-06-30
Completion
2026-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07351565 on ClinicalTrials.gov