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

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 ev

Trial Details

NCT ID
NCT07754812
Phase
PHASE4
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Oral Paclitaxel Solution
  • PD-1/PD-L1 inhibitor
  • Stereotactic Body Radiotherapy (SBRT)
  • Radical Lung Cancer Surgery
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Suqian, Jiangsu, China|33.94917,118.29583
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806
  • Hangzhou, Zhejiang, China|30.29365,120.16142
  • Lishui, Zhejiang, China|28.46042,119.91029

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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