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

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.

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Key information

Conditions

Non-Small-Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoadjuvant Therapy Neoplasms Neoplasms by Site Paclitaxel Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

70 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 infection, chronic hepatitis B/C with active replication, or syphilis
Severe cardiac, hepatic, renal, or metabolic disease that cannot tolerate surgery or study treatment
Previous interstitial lung disease, drug-induced pneumonitis, or radiologic evidence of active interstitial lung disease
Uncontrolled massive pleural effusion or pericardial effusion
Major surgery, severe trauma, or other investigational drug therapy within 4 weeks
Recent vaccination with antitumor vaccines or live vaccines
Other conditions deemed inappropriate for enrollment or likely to affect trial outcomes by the investigator

Treatment and study plan

Paclitaxel Oral Solution

Drug

Oral Paclitaxel Solution: 200 mg/m² administered on a 21-day cycle, with oral doses given on Day 1 and Day 8 of each cycle, taken twice daily (morning and evening).

Immunotherapy: Anti-PD-1 or anti-PD-L1 monoclonal antibodies will be administered in combination. The specific agent will be selected by the investigator in accordance with the Standard of Care (SOC), and the dosing regimen will be implemented in line with the drug's official prescribing information.

Primary outcomes

Pathological Complete Response (pCR)

Time frame: up to 30 months

pCR refers to the absence of viable residual tumor cells in surgically resected tissue samples after treatment

Secondary outcomes

Adverse Reaction Incidence Rate

Time frame: up to 30 months

It refers to the proportion of subjects with treatment-related adverse reactions among all enrolled subjects during the study period, which is applied to evaluate the clinical safety of the intervention measure.

Study contacts

Contact information is provided by the study sponsor or research team.

peng zhang

CONTACT

[email protected]

13512185932

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2030
First posted: May 20, 2026
Registry last updated: May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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