NCT05244213 (NEOTIDE) is a Phase 2 clinical trial of Sintilimab in Non-small Cell Lung Cancer, sponsored by Guangdong Provincial People's Hospital.

Who is sponsoring NCT05244213?

NCT05244213 is sponsored by Guangdong Provincial People's Hospital.

What drugs are being tested in NCT05244213?

Interventions in NCT05244213: Sintilimab, Carboplatin, Nab paclitaxel.

What condition does NCT05244213 study?

NCT05244213 studies Non-small Cell Lung Cancer, EGFR Activating Mutation.

Is NCT05244213 still recruiting?

NCT05244213 is currently active, enrolled. Last updated 8 July 2024.

Last reviewed 2024-07-08 · How we verify

NCT05244213: NEOTIDE

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

Neoadjuvant Immunotherapy in EGFR-mutant Localized NSCLC

Active, enrolled Phase 2 Last updated 8 July 2024

What this trial tests

Phase 2 trial testing Sintilimab in Non-small Cell Lung Cancer in 35 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

4 June 2022

Primary endpoint
5 June 2024

1 December 2025

Quick facts

Lead sponsor	Guangdong Provincial People's Hospital
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	4 June 2022
Primary completion	5 June 2024
Estimated completion	1 December 2025
Sites	1 location across China

Drugs / interventions tested

Sintilimab — full drug profile →
Carboplatin (Carboplatin) — full drug profile →
Nab paclitaxel

Conditions studied

Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
EGFR Activating Mutation — all drugs for EGFR Activating Mutation →

Sponsor

Guangdong Provincial People's Hospital

Who can join

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

Sponsor's own description

Phase II, single-arm, open-label single center study that assess clinical feasibility and safety of 3 cycles neoadjuvant Sintilimab plus chemotherapy in EGFR-mutant stage IIB-IIIB NSCLC (excluding N3) followed by optional adjuvant treatment upon investigators' decisions.

Publications & conference data

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

Neoadjuvant sintilimab plus chemotherapy in EGFR-mutant NSCLC: Phase 2 trial interim results (NEOTIDE/CTONG2104).
Zhang C, Sun YX, Yi DC, Jiang BY, et al · · 2024 · cited 26× · PMID 38897205 · DOI 10.1016/j.xcrm.2024.101615
Immunological features of EGFR-mutant non-small cell lung cancer and clinical practice: a narrative review.
Dong Y, Khan L, Yao Y. · · 2024 · cited 13× · PMID 39735443 · DOI 10.1016/j.jncc.2024.06.004
Combatting acquired resistance to osimertinib in EGFR-mutant lung cancer.
Lee J, Piotrowska Z, Soo R, Cho BC, et al · · 2022 · cited 9× · PMID 36544540 · DOI 10.1177/17588359221144099
Landscape of Genomic Alterations and PD-L1 Expression in Early-Stage Non-Small-Cell Lung Cancer (NSCLC)-A Single Center, Retrospective Observational Study.
Stephan-Falkenau S, Streubel A, Mairinger T, Kollmeier J, et al · · 2022 · cited 8× · PMID 36293366 · DOI 10.3390/ijms232012511
Is Immunotherapy Beneficial in Patients with Oncogene-Addicted Non-Small Cell Lung Cancers? A Narrative Review.
McMahon DJ, McLaughlin R, Naidoo J. · · 2024 · cited 7× · PMID 38339280 · DOI 10.3390/cancers16030527
Conversion therapy with immunotherapy plus chemotherapy achieves a pathological complete response in stage IIIC NSCLC.
Fu Y, Duan W, Xu R, Chen J. · · 2023 · cited 1× · PMID 38022567 · DOI 10.3389/fimmu.2023.1268153
Neoadjuvant sintilimab plus chemotherapy in EGFR-mutant non-small cell lung cancer (NEOTIDE/CTONG2104): phase II trial and correlative genomic analysis in China.
Zhang C, Jiang BY, Yan LX, Peng LS, et al · · 2026 · PMID 42256683 · DOI 10.1016/j.eclinm.2026.103994

Verify or expand the search:

Other trials of Sintilimab

Trials testing the same drug.

NCT07535632 — SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cance · Phase 2 · not yet recruiting
NCT07537946 — Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer · Phase 3 · not yet recruiting
NCT07537972 — Denosumab Strategy for Liver Cancer With Bone Metastases · Phase 2 · not yet recruiting
NCT07468630 — Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma · Phase 2 · recruiting
NCT07515625 — Efficacy of Sintilimab Combined With Bevacizumab and XELOX/SOX in Initially Unresectable AFP-positive Gastric/Gastroesop · Phase 2 · not yet recruiting

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 Guangdong Provincial People's Hospital trials

Trials by the same sponsor.

NCT07521605 — Short-Course Radiotherapy, Nal-IRI, Capecitabine, and Camrelizumab for Locally Advanced MSS Rectal Cancer · Phase 2 · not yet recruiting
NCT07514611 — Weight Loss Via Intelligent Guidance in Patients With Coronary Heart Disease and Obesity: a Randomized Clinical Trial · NA · recruiting
NCT07352930 — A Novel Intraoperative Fluorescence-guided System for Evaluating Margins During Breast-conserving Surgery for Breast Can · NA · not yet recruiting
NCT07472478 — Phase II Neoadjuvant Study of Garsorasib Followed by Ivonescimab Plus Chemotherapy in Resectable Stage IIA-IIIB KRAS G12 · Phase 2 · not yet recruiting
NCT07483398 — RELIEF-PD: Crisugabalin for Nociplastic Pain in Parkinson's Disease · Phase 4 · active not 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 NCT05244213 (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 Guangdong Provincial People's Hospital
Last refreshed: 8 July 2024

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/NCT05244213.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing