Perioperative sintilimab and neoadjuvant anlotinib plus chemotherapy for resectable non-small-cell lung cancer: a multicentre, open-label, single-arm, phase 2 trial (TD-NeoFOUR trial).
Humans
Female
Male
Carcinoma, Non-Small-Cell Lung
/ drug therapy
Lung Neoplasms
/ drug therapy
Middle Aged
Quinolines
/ administration & dosage
Aged
Neoadjuvant Therapy
Indoles
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Antibodies, Monoclonal, Humanized
/ administration & dosage
Adult
Journal
Signal transduction and targeted therapy
ISSN: 2059-3635
Titre abrégé: Signal Transduct Target Ther
Pays: England
ID NLM: 101676423
Informations de publication
Date de publication:
28 Oct 2024
28 Oct 2024
Historique:
received:
06
03
2024
accepted:
26
09
2024
revised:
10
09
2024
medline:
28
10
2024
pubmed:
28
10
2024
entrez:
28
10
2024
Statut:
epublish
Résumé
This open-label, single-arm, phase 2 trial evaluated the efficacy and safety of neoadjuvant sintilimab combined with anlotinib and chemotherapy, followed by adjuvant sintilimab, for resectable NSCLC. Forty-five patients received anlotinib (10 mg, QD, PO, days 1-14), sintilimab (200 mg, day 1), and platinum-based chemotherapy of each three-week cycle for 3 cycles, followed by surgery within 4-6 weeks. Adjuvant sintilimab (200 mg) was administered every 3 weeks. The primary endpoint was achieving a pathological complete response (pCR). From June 10, 2021 through October 10, 2023, 45 patients were enrolled and composed the intention-to-treat population. Twenty-six patients (57.8%) achieved pCR, and 30 (66.7%) achieved major pathological response (MPR). Forty-one patients underwent surgery. In the per-protocol set (PP set), 63.4% (26/41) achieved pCR, and 73.2% achieved MPR. The median event-free survival was not attained (95% CI, 25.1-NE). During the neoadjuvant treatment phase, grade 3 or 4 treatment-related adverse events were observed in 25 patients (55.6%), while immune-related adverse events were reported in 7 patients (15.6%). We assessed vascular normalization and infiltration of immune-related cells by detecting the expression of relevant cell markers in NSCLC tissues with mIHC. Significant tumor microenvironment changes were observed in pCR patients, including reduced VEGF
Identifiants
pubmed: 39465257
doi: 10.1038/s41392-024-01992-0
pii: 10.1038/s41392-024-01992-0
doi:
Substances chimiques
Quinolines
0
anlotinib
0
Indoles
0
sintilimab
8FU7FQ8UPK
Antibodies, Monoclonal, Humanized
0
Banques de données
ClinicalTrials.gov
['NCT05400070']
Types de publication
Journal Article
Clinical Trial, Phase II
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
296Subventions
Organisme : National Natural Science Foundation of China (National Science Foundation of China)
ID : 82173252
Informations de copyright
© 2024. The Author(s).
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