Who is sponsoring NCT05549037?

NCT05549037 is sponsored by Hunan Province Tumor Hospital.

What drugs are being tested in NCT05549037?

Interventions in NCT05549037: Pembrolizumab, Sintilimab.

What condition does NCT05549037 study?

NCT05549037 studies Non-small Cell Lung Cancer.

Is NCT05549037 still recruiting?

NCT05549037 is currently recruiting now. Last updated 19 February 2025.

Last reviewed 2025-02-19 · How we verify

NCT05549037: PACIFIC15

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of Time-of-Day (ToD) for Immunochemotherapy on PFS in NSCLC

Recruiting now Phase 3 Last updated 19 February 2025

What this trial tests

Phase 3 trial testing Pembrolizumab, Sintilimab in Non-small Cell Lung Cancer in 210 participants. Currently enrolling.

Timeline

23 September 2022

Primary endpoint
2 December 2024

31 December 2025

Quick facts

Lead sponsor	Hunan Province Tumor Hospital
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	210
Start date	23 September 2022
Primary completion	2 December 2024
Estimated completion	31 December 2025
Sites	1 location across China

Drugs / interventions tested

Pembrolizumab, Sintilimab — full drug profile →

Conditions studied

Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →

Sponsor

Hunan Province Tumor Hospital

Who can join

Adults 18 to 75, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to explore time-of-day of administration of immunochemotherapy on the efficacy for treatment naive advanced non-small cell lung cancer.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Overall survival according to time-of-day of combined immuno-chemotherapy for advanced non-small cell lung cancer: a bicentric bicontinental study.
Huang Z, Karaboué A, Zeng L, Lecoeuvre A, et al · · 2025 · cited 16× · PMID 39983330 · DOI 10.1016/j.ebiom.2025.105607
Personalization of Cancer Treatment: Exploring the Role of Chronotherapy in Immune Checkpoint Inhibitor Efficacy.
Fey RM, Billo A, Clister T, Doan KL, et al · · 2025 · cited 7× · PMID 40075580 · DOI 10.3390/cancers17050732
Time-of-day immunochemotherapy in non-small cell lung cancer: a randomized phase 3 trial.
Huang Z, Zeng L, Ruan Z, Zeng Q, et al · · 2026 · cited 3× · PMID 41629425 · DOI 10.1038/s41591-025-04181-w
Chrono-immunotherapy's current and future optimization strategies: immunotherapy timing in line with the circadian rhythm brings longer survival benefits.
Liu D, Li Z, Cui H, Zhang H, et al · · 2026 · PMID 41777887 · DOI 10.3389/fimmu.2026.1777437
Hepatocellular Carcinoma Around the Clock.
Machado MV. · · 2026 · PMID 41590352 · DOI 10.3390/curroncol33010032

Verify or expand the search:

Other recruiting trials for Non-small Cell Lung Cancer

Currently open trials in the same condition.

NCT07431827 — MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) · Phase 3 · recruiting
NCT05987956 — Pharmacogenomics IND EXEMPT SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms · Phase 2, PHASE3 · active not recruiting
NCT07195695 — Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer Wit · Phase 3 · recruiting
NCT06686771 — Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer · Phase 3 · recruiting
NCT06477055 — The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer · recruiting

Other Hunan Province Tumor Hospital trials

Trials by the same sponsor.

NCT06706219 — Efficacy and Safety of Sacituzumab Tirumotecan (SKB264) in Combination With Toripalimab in Patients With Initially Unres · Phase 2 · not yet recruiting
NCT07001995 — Limertinib Plus Carboplatin and Etoposide for EGFR-mutant NSCLC With SCLC Transformation After EGFR-TKI Progression · Phase 2 · not yet recruiting
NCT07477808 — Megestrol Acetate for First-Line Treatment of Malnourished Non-Small Cell Lung Cancer · Phase 3 · not yet recruiting
NCT07251582 — Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer · Phase 3 · recruiting
NCT06477055 — The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05549037 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hunan Province Tumor Hospital
Last refreshed: 19 February 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05549037.

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