NCT07599163Not yet recruiting

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

A Phase II, Multicenter Clinical Study of Oral Paclitaxel Solution as Neoadjuvant Therapy in Elderly Patients With Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 20 May 2026

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Study type: Interventional
Enrollment: 75 (estimated)
First submitted: 21 Apr 2026
Start date: 8 Jun 2026
Primary completion date: 1 Jan 2029
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Diseases: Lung cancer
NCT number: NCT07599163

What you commit to

Study type: Interventional
Planned participants: 75
From 8 Jun 2026 to the primary completion date, 1 Jan 2029
No sites listed in no country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Previous lobectomy, radiotherapy, or systemic antitumor therapy
Previous interstitial lung disease, drug-induced pneumonitis, or radiologic evidence of active interstitial lung disease
Major surgery, severe trauma, or other investigational drug therapy within 4 weeks
Recent vaccination with antitumor vaccines or live vaccines

Other illness

History of active autoimmune disease or requirement for systemic immunosuppressive therapy
Active infection requiring systemic therapy, including active tuberculosis, HIV infection, chronic hepatitis B/C with active replication, or syphilis
Severe cardiac, hepatic, renal, or metabolic disease that cannot tolerate surgery or study treatment
Other conditions deemed inappropriate for enrollment or likely to affect trial outcomes by the investigator

Age

Synchronous other malignancy with \<5 years of cure (except carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin)

Other

Uncontrolled massive pleural effusion or pericardial effusion

Who the study is looking for

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

Criteria the registry did not label

Eligibility Criteria

Age in the registry: 70 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.