Oral Paclitaxel Solution With Immunotherapy and Concurrent SBRT as Neoadjuvant Treatment for Older Adults With NSCLC
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 70 lat lub więcej
- •Dobry ogólny stan zdrowia (możliwość poruszania się i codziennych czynności)
- •Potwierdzony rak płuca w stadiums IIA-IIIB bez przerzutów
- •Możliwość operacyjnego usunięcia guza
- •Normalne lub prawie normalne funkcje wątroby, nerek i serca
- •Dobra funkcja płuc (w tym prognozowana zdolność oddychania po operacji)
- •Bez zawału serca w ostatnim roku i bez poważnych zaburzeń pracy serca
- •Świadoma zgoda na udział w badaniu
✗ Disqualifies
- •Wcześniejsza operacja lub radioterapia płuc
- •Inne nowotwory równocześnie lub wyleczone mniej niż 5 lat temu
- •Aktywna autoimmunologiczna choroba
- •Wcześniejsza chemioterapia lub immunoterapia
Simplified criteria — AI translation
Trial details
- Minimum age
- 70 Years
- Last updated (source)
- August 10, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (5)
Guangdong Provincial People's Hospital
Guangzhou, China
The Affiliated Suqian Hospital of Xuzhou Medical University
Suqian, China
Shanghai Pulmonary Hospital
Shanghai, China
Zhejiang Cancer Hospital
Hangzhou, China
Lishui People's Hospital
Lishui, China
Trial contact
Xiaoling Xu, MD, PhD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/11/2026.
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