Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07754812

PHASE4

Oral Paclitaxel Solution With Immunotherapy and Concurrent SBRT as Neoadjuvant Treatment for Older Adults With NSCLC

Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

View on ClinicalTrials.gov

Summary

his multicenter, open-label, single-arm phase I/II trial will evaluate the safety, tolerability, and preliminary efficacy of oral paclitaxel solution combined with an immune checkpoint inhibitor and concurrent stereotactic body radiotherapy (SBRT) as neoadjuvant therapy in patients aged 70 years or older with resectable stage IIA-IIIB non-small cell lung cancer (NSCLC) without sensitizing EGFR, ALK, or ROS1 alterations. In Phase I, a 3+3 dose-escalation design will evaluate oral paclitaxel at 80, 120, and 160 mg/m² administered orally on Days 1 and 8 of each cycle, divided into morning and evening doses, in combination with an investigator-selected anti-PD-1 or anti-PD-L1 monoclonal antibody and SBRT at 8 Gy in 3 fractions. Phase II will expand enrollment at the recommended Phase II dose (RP2D). The principal efficacy outcome is pathologic complete response after surgery. Other outcomes include major pathologic response, radiographic response, event-free survival, overall survival, surgical resection and R0 resection rates, and exploratory biomarker changes.

Official title: A Multicenter, Open-Label, Single-Arm Phase I/II Study of Oral Paclitaxel Solution Combined With an Immune Checkpoint Inhibitor and Concurrent Stereotactic Body Radiotherapy as Neoadjuvant Treatment in Older Patients With Resectable Stage IIA-IIIB Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06-25

Completion Date

2028-10-31

Last Updated

2026-08-10

Healthy Volunteers

Conditions

NSCLC (Non-small Cell Lung Cancer)

Interventions

DRUG

Oral Paclitaxel Solution

Phase I dose levels: 80 mg/m², 120 mg/m², and 160 mg/m², administered orally on Days 1 and 8 of each cycle in divided morning and evening doses. Phase II: oral paclitaxel solution at the RP2D.

DRUG

PD-1/PD-L1 inhibitor

An PD-1/PD-L1 inhibitor selected by the investigator according to standard of care and administered according to the approved prescribing information

RADIATION

Stereotactic Body Radiotherapy (SBRT)

SBRT at 8 Gy per fraction for 3 fractions to the primary lung tumor and selected lymph node regions.

PROCEDURE

Radical Lung Cancer Surgery

Participants considered operable after neoadjuvant therapy are intended to undergo radical lung cancer surgery.

RADIATION

Stereotactic Body Radiotherapy (SBRT)

Participants considered inoperable after neoadjuvant therapy are intended to continue SBRT at radical dose assessed by department of radiotherapy.

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.

Locations (5)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The Affiliated Suqian Hospital of Xuzhou Medical University

Suqian, Jiangsu, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Lishui People's Hospital

Lishui, Zhejiang, China