OncoMatch/Clinical Trials/NCT07744698
Metronomic Oral Paclitaxel Plus PD-1/ PD-L1 Inhibitor Maintenance in Advanced Lung Cancer (PULSE Study)
Is NCT07744698 recruiting? Yes, currently enrolling (Sep 2026). This Phase 4 trial studies multiple treatments including Paclitaxel Oral Solution and PD-1/PD-L1 inhibitor (eg. Tislelizumab) for squamous non-small cell lung cancer sqnsclc.
Treatment: Paclitaxel Oral Solution · PD-1/PD-L1 inhibitor (eg. Tislelizumab) — This study will evaluate the efficacy and safety of metronomic oral paclitaxel combined with a PD-1 or PD-L1 inhibitor as maintenance therapy in patients with advanced lung cancer whose disease has not progressed after first-line chemoimmunotherapy. The study will include two independently analyzed cohorts. Cohort A will include patients with advanced squamous non-small cell lung cancer(sqNSCLC), and Cohort B will include patients with extensive-stage small cell lung cancer(ES-SCLC). All participants will receive oral paclitaxel three times weekly together with the same immune checkpoint inhibitor used during first-line induction therapy, whenever feasible. The primary outcome is progression-free survival. Other outcomes include tumor response, overall survival, adverse events, treatment tolerability, and quality of life. Approximately 107 participants will be enrolled across multiple study centers.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Small Cell Lung Cancer
Biomarker criteria
Required: ALK wild-type
Required: EGFR wild-type
Required: ROS1 wild-type
Disease stage
Required: Stage IIIB, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: first-line induction therapy (PD-1 or PD-L1 inhibitor plus platinum doublet) (PD-1 inhibitor, PD-L1 inhibitor, cisplatin, carboplatin, paclitaxel, nab-paclitaxel, etoposide) — first-line induction for advanced sqNSCLC or ES-SCLC
Completion of four cycles of a PD-1 or PD-L1 inhibitor plus cisplatin or carboplatin and paclitaxel or nab-paclitaxel (Cohort A) or etoposide (Cohort B), with a best induction response of CR, PR, or SD and no evidence of disease progression
Lab requirements
Blood counts
ANC ≥1.5 × 10⁹/L, platelets ≥100 × 10⁹/L, hemoglobin ≥90 g/L without transfusion, growth-factor support, or erythropoietin within 14 days
Kidney function
Serum creatinine ≤1.5x ULN and creatinine clearance ≥60 mL/min (cisplatin) or >45 mL/min (carboplatin), Cockcroft-Gault formula
Liver function
Total serum bilirubin ≤1.5x ULN (≤3x ULN for Gilbert syndrome); ALT/AST ≤2.5x ULN (≤5x ULN with liver metastases); serum amylase/lipase ≤1.5x ULN
Adequate bone marrow and organ function, including: ANC ≥1.5 × 10⁹/L, platelets ≥100 × 10⁹/L, hemoglobin ≥90 g/L, INR/PT/APTT ≤1.5x ULN, total bilirubin ≤1.5x ULN (≤3x ULN for Gilbert syndrome), ALT/AST ≤2.5x ULN (≤5x ULN with liver metastases), serum creatinine ≤1.5x ULN and creatinine clearance ≥60 mL/min (cisplatin) or >45 mL/min (carboplatin), serum amylase/lipase ≤1.5x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07744698 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received first-line induction therapy (PD-1 or PD-L1 inhibitor plus platinum doublet).
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 IIIB or IV is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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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