OncoMatch/Clinical Trials/NCT05549037
Effect of Time-of-Day (ToD) for Immunochemotherapy on PFS in NSCLC
Is NCT05549037 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Pembrolizumab, Sintilimab for non-small cell lung cancer.
Treatment: Pembrolizumab, Sintilimab — This study aims to explore time-of-day of administration of immunochemotherapy on the efficacy for treatment naive advanced non-small cell lung cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK wild-type
Required: EGFR wild-type
Required: ROS1 wild-type
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Prior systemic therapy for locally advanced or metastatic disease
Cannot have received: chemotherapy
Exception: adjuvant/neoadjuvant therapy allowed if not within 4 weeks prior to first dose
Treatment with chemotherapy or molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug
Cannot have received: EGFR antibody
Treatment with molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug
Cannot have received: VEGFR antibody
Treatment with molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug
Cannot have received: radiation therapy
Exception: chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose
Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity
Lab requirements
Blood counts
Adequate bone marrow hematopoiesis
Kidney function
Liver function
Adequate bone marrow hematopoiesis and organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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