Loading
Stereotactic Body Radiotherapy (SBRT) / Oral Paclitaxel Solution / Radical Lung Cancer Surgery · Phase 4 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for an active Phase I/II trial evaluating oral paclitaxel, anti-PD-1/PD-L1 immunotherapy, and concurrent SBRT as neoadjuvant therapy in older adults with resectable NSCLC. No efficacy or safety results are posted; the study remains in recruitment phase and represents early-stage clinical investigation.
Phase 4, Interventional, Randomized, Parallel, Open label, Treatment purpose. NSCLC (Non-small Cell Lung Cancer); age from 70 Years. Intervention: Phase 1 Dose-Escalation Cohort; Phase 2 Cohort A - Operable Cohort; Phase 2 Cohort B - Inoperable Cohort. n = 78. 5 sites: China.
This is a registry record for an active Phase I/II trial evaluating oral paclitaxel, anti-PD-1/PD-L1 immunotherapy, and concurrent SBRT as neoadjuvant therapy in older adults with resectable NSCLC. No efficacy or safety results are posted; the study remains in recruitment phase and represents early-stage clinical investigation.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Clinicians should not alter practice based on this record. The trial is in early recruitment and has not yet reported safety or efficacy data. Results from Phase I dose escalation and Phase II expansion will be needed to inform treatment decisions in this population.
This is a Phase I/II trial registration with planned enrollment of 78 older adults; no results are posted, and the study is actively recruiting, making it an early-phase assessment of a novel combination.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should not alter practice based on this record. The trial is in early recruitment and has not yet reported safety or efficacy data. Results from Phase I dose escalation and Phase II expansion will be needed to inform treatment decisions in this population.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07754812). This is a study registration, not published results. Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 78 participants (ESTIMATED). Conditions: NSCLC (Non-small Cell Lung Cancer). Interventions: DRUG: Oral Paclitaxel Solution; DRUG: PD-1/PD-L1 inhibitor; RADIATION: Stereotactic Body Radiotherapy (SBRT); PROCEDURE: Radical Lung Cancer Surgery; RADIATION: Stereotactic Body Radiotherapy (SBRT). Primary outcome measures: Complete Response (CR) Rate in Phase 2 , 2 weeks (±14 days) after surgery or radical radiotherapy; Incidence of Grade 3 or Higher Treatment-Related Adverse Events (TRAE) in Phase 1 , First dose up to 1 week (±7 days) after neoadjuvant therapy. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.