Oral Paclitaxel with Immunotherapy and SBRT as Neoadjuvant Treatment for Older Adults with NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label, single-arm study is designed to determine the safety, tolerability, and preliminary effectiveness of a neoadjuvant regimen that combines oral paclitaxel, a PD-1/PD-L1 inhibitor chosen by the investigator, and stereotactic body radiotherapy. Phase I uses a 3+3 dose-escalation to find the recommended Phase II dose of oral paclitaxel given on Days 1 and 8 of each cycle, with SBRT delivered concurrently. Phase II will expand at the RP2D to evaluate antitumor activity, surgical feasibility, and survival outcomes, with exploratory analyses of immune correlates. Eligible patients are 70 years or older with resectable stage IIA-IIIB NSCLC, no driving mutations, good organ function, and suitable for radical surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 70 years or older, regardless of sex.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Histologically confirmed non-small cell lung cancer, clinical stage IIA-IIIB according to the 8th edition of the AJCC staging system.
* No evidence of distant metastasis and considered suitable for radical lung cancer surgery.
* The primary lung lesion is suitable for stereotactic body radiotherapy.
* No sensitizing driver alterations in EGFR, ALK, ROS1, or other tested actionable genes.
* Adequate major organ function, including all of the following:
* Absolute neutrophil count at least 1.5 × 10\^9/L, platelet count at least 100 × 10\^9/L, and hemoglobin at least 9 g/dL.
* Total bilirubin no more than 1.5 × the upper limit of normal; alanine aminotransferase and aspartate aminotransferase no more than 2.5 × the upper limit of normal.
* Serum creatinine no more than 1.5 × the upper limit of normal or creatinine clearance at least 60 mL/min.
* Urine protein less than 1+; if urine protein is 1+, 24-hour urine protein must be less than 500 mg.
* Blood glucose within the normal range or stable glycemic control in participants with diabetes.
* Baseline forced expiratory volume in 1 second (FEV1) at least 2 L; if FEV1 is less than 2 L, the predicted postoperative FEV1 must be greater than 800 mL as assessed by a thoracic surgeon.
* No myocardial infarction within the previous year, no unstable angina, no symptomatic severe arrhythmia, and no cardiac insufficiency.
* The participant has been fully informed and voluntarily provides written informed consent.

Exclusion Criteria:

* Prior lobectomy, thoracic radiotherapy, or systemic antitumor therapy.
* Another concurrent malignancy or a history of another malignancy cured less than 5 years before enrollment, except adequately treated cervical carcinoma in situ or basal cell or squamous cell carcinoma of the skin.
* Active autoimmune disease or a history of autoimmune disease requiring systemic immunosuppressive treatment.
* Active infection requiring systemic treatment, active tuberculosis, human immunodeficiency virus infection, active hepatitis B or hepatitis C, active syphilis, or another active transmissible infection specified by the protocol.
* Severe cardiac, hepatic, renal, or metabolic disease that precludes surgery or study treatment.
* History of interstitial lung disease or drug-induced pneumonitis, or imaging evidence of active interstitial lung disease.
* Uncontrolled large pleural effusion or pericardial effusion.
* Major surgery, severe trauma, or treatment with another investigational drug within 4 weeks before enrollment.
* Recent receipt of an anticancer vaccine or live vaccine.
* Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study or may interfere with interpretation of the study results.

Where it's running

• Shanghai Pulmonary Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Not yet recruiting
• The Affiliated Suqian Hospital of Xuzhou Medical University
  Suqian, Jiangsu, China Not yet recruiting
• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Not yet recruiting
• Lishui People's Hospital
  Lishui, Zhejiang, China Not yet recruiting

Study contacts

• Principal investigator: Xiaoling Xu, MD, PhD — Shanghai Pulmonary Hospital, Shanghai, China
• Study coordinator: Xiaoling Xu, MD, PhD
• Email: xuxl@zjcc.org.cn
• Phone: +86-21-65115006

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.