Not Yet RecruitingNot Applicable

Oral Paclitaxel as Neoadjuvant Therapy in Elderly NSCLC: A Phase II Trial

75 participantsStarted 2026-06-08

Plain-language summary

This study is a multicenter, single-arm Phase II clinical trial, aiming to explore the safety and preliminary efficacy of oral paclitaxel solution combined with immune checkpoint inhibitors as a neoadjuvant regimen in elderly patients aged 70-85 years with non-small cell lung cancer (NSCLC). A total of 75 eligible elderly NSCLC patients who need neoadjuvant treatment are planned to be enrolled. The study takes Shanghai Pulmonary Hospital as the main center, Zhejiang Cancer Hospital and Guangdong Provincial People's Hospital as sub-centers, adopts a single-arm study design, and the research subjects are elderly NSCLC patients who need neoadjuvant treatment. The core indicators for efficacy evaluation include pathological complete response rate (pCR), major pathological response rate (MPR, residual tumor cells ≤10%), imaging response rate (according to RECIST 1.1 criteria), 2-year event-free survival rate (EFS), 2-year overall survival rate (OS), surgical resection rate, and R0 resection rate; safety evaluation mainly observes the incidence of adverse events. The statistical methods adopt the relevant specifications for single-arm exploratory studies. Efficacy analysis is carried out in the full analysis set and per-protocol set, and safety analysis is performed using the safety analysis set; for continuous variables, paired t-test or Wilcoxon signed-rank test is used according to the distribution; categorical variables are analyzed descriptively; for the main rate-type outcome indicators, the incidence rate and 95% confidence interval (Clopper-Pearson method) are reported; survival outcome indicators are estimated using the Kaplan-Meier method and relevant parameters are reported.

Who can participate

Age range

70 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Eligibility Criteria Inclusion Criteria: * Age 70-85 years, any gender * ECOG performance status 0-1 * Pathologically confirmed non-small cell lung cancer (NSCLC), clinical stage IIA-IIIB (8th edition AJCC) * No distant metastasis, deemed resectable with curative intent * Negative for sensitive driver mutations including EGFR, ALK, and ROS1 by molecular pathology * Adequate function of major organs, defined as: * Bone marrow: ANC ≥1.5×10⁹/L, platelet ≥100×10⁹/L, hemoglobin ≥9 g/dL * Liver function: total bilirubin ≤1.5×ULN; ALT, AST ≤2.5×ULN * Renal function: serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min; urine protein \< +; if +, 24-h urine protein \< 500 mg * Normal blood glucose or well-controlled diabetes * Pulmonary function: baseline FEV1 ≥2 L; if FEV1 \< 2 L, postoperative predicted FEV1 \> 800 mL confirmed by surgical evaluation * Cardiac function: no myocardial infarction, unstable angina, severe arrhythmia, or cardiac insufficiency within the past 1 year * Patients and families are fully informed and voluntarily provide written informed consent Exclusion Criteria: * Previous lobectomy, radiotherapy, or systemic antitumor therapy * Synchronous other malignancy with \<5 years of cure (except carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin) * History of active autoimmune disease or requirement for systemic immunosuppressive therapy * Active infection requiring systemic therapy, including active tuberculosis, HIV inf…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pathological Complete Response (pCR)

Timeframe: up to 30 months

Trial details

NCT IDNCT07599163

SponsorShanghai Pulmonary Hospital, Shanghai, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01-01

Contact for this trial

peng zhang

13512185932 zhangpeng1121@tongji.edu.cn

View on ClinicalTrials.gov More Non-Small-Cell Lung Cancer trials