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

NCT07754812 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-08-10

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Shanghai Pulmonary Hospital, Shanghai, China

    lead OTHER

Principal Investigators

  • Xiaoling Xu, MD, PhD · Shanghai Pulmonary Hospital, Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-25
Primary Completion
2028-10-31
Completion
2028-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07754812 on ClinicalTrials.gov