OncoMatch/Clinical Trials/NCT07754812
Oral Paclitaxel Solution With Immunotherapy and Concurrent SBRT as Neoadjuvant Treatment for Older Adults With NSCLC
Is NCT07754812 recruiting? Yes, currently enrolling (Sep 2026). This Phase 4 trial studies multiple treatments including Oral Paclitaxel Solution and PD-1/PD-L1 inhibitor for nsclc (non-small cell lung cancer).
Treatment: Oral Paclitaxel Solution · PD-1/PD-L1 inhibitor — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK wild-type
Required: EGFR wild-type
Required: ROS1 wild-type
Disease stage
Required: Stage IIA, IIB, IIIA, IIIB
Performance status
ECOG 0–1(Restricted strenuous activity)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Demographics
Prior therapy
Cannot have received: lobectomy
Cannot have received: thoracic radiotherapy
Cannot have received: systemic antitumor therapy
Lab requirements
Blood counts
Absolute neutrophil count at least 1.5 × 10^9/L, platelet count at least 100 × 10^9/L, hemoglobin at least 9 g/dL
Kidney function
Serum creatinine no more than 1.5 × ULN or creatinine clearance at least 60 mL/min; urine protein less than 1+ or 24-hour urine protein less than 500 mg
Liver function
Total bilirubin no more than 1.5 × ULN; ALT and AST no more than 2.5 × ULN
Cardiac function
No myocardial infarction within the previous year, no unstable angina, no symptomatic severe arrhythmia, and no cardiac insufficiency
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 × ULN; ALT and AST no more than 2.5 × ULN. Serum creatinine no more than 1.5 × ULN 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 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07754812 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
Does this trial require ROS1?
Yes, ROS1 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIA or IIB or IIIA or IIIB is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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