NCT04325763 is a Phase 3 clinical trial of TQB2450 in Stage III Non-small-cell Lung Cancer, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..

Who is sponsoring NCT04325763?

NCT04325763 is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..

What drugs are being tested in NCT04325763?

Interventions in NCT04325763: TQB2450, Anlotinib, TQB2450(blank), Anlotinib(blank).

What condition does NCT04325763 study?

NCT04325763 studies Stage III Non-small-cell Lung Cancer.

Is NCT04325763 still recruiting?

NCT04325763 is currently status unknown. Last updated 15 March 2022.

Last reviewed 2022-03-15 · How we verify

NCT04325763

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

A Randomized, Double-blind and Imitation, Placebo Parallel Control, Multicentre Phase III Study of TQB2450 With or Without Anlotinib as Consolidation Treatment in Subjects With Locally Advanced/Unresectable (Stage III) Non-Small Cell Lung Cancer That Have Not Progressed After Prior Concurrent/Sequential Chemoradiotherapy

Status unknown Phase 3 Last updated 15 March 2022

What this trial tests

Phase 3 trial testing TQB2450 in Stage III Non-small-cell Lung Cancer in 315 participants. Status unknown.

Timeline

27 May 2020

Primary endpoint
1 December 2022

1 March 2025

Quick facts

Lead sponsor	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	315
Start date	27 May 2020
Primary completion	1 December 2022
Estimated completion	1 March 2025
Sites	36 locations across China

Drugs / interventions tested

TQB2450
Anlotinib — full drug profile →
TQB2450(blank) — full drug profile →
Anlotinib(blank) — full drug profile →

Conditions studied

Stage III Non-small-cell Lung Cancer — all drugs for Stage III Non-small-cell Lung Cancer →

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full company profile →

Who can join

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

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Progression Free Survival (PFS) evaluated by Independent Review Committee(IRC)
Time frame: up to 33 months
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.

Sponsor's own description

This study is a randomized, double-blind, double-dummy,placebo parallel controlled, multi-centre,phase III clinical trial to evaluate the efficacy and safety of TQB2450 with or without anlotinib compared with placebo as consolidation treatment in subjects with locally advanced/unresectable (Stage III) Non-Small Cell Lung Cancer that has not progressed after prior concurrent/sequential chemoradiotherapy.

Publications & conference data

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

Antibodies to watch in 2021.
Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476
Signaling pathways and targeted therapies in lung squamous cell carcinoma: mechanisms and clinical trials.
Niu Z, Jin R, Zhang Y, Li H. · · 2022 · cited 127× · PMID 36198685 · DOI 10.1038/s41392-022-01200-x
Emerging evidence and treatment paradigm of non-small cell lung cancer.
Liu SM, Zheng MM, Pan Y, Liu SY, et al · · 2023 · cited 70× · PMID 37069698 · DOI 10.1186/s13045-023-01436-2
Radiation combined with immune checkpoint inhibitors for unresectable locally advanced non-small cell lung cancer: synergistic mechanisms, current state, challenges, and orientations.
Wu L, Zhang Z, Bai M, Yan Y, et al · · 2023 · cited 29× · PMID 37221584 · DOI 10.1186/s12964-023-01139-8
Combination Immunotherapy With Radiotherapy in Non-Small Cell Lung Cancer: A Review of Evidence.
Burr JL, Johnson KC, Carmicheal JJ, Lin C, et al · · 2024 · cited 5× · PMID 39526426 · DOI 10.1002/cam4.70402
TQB2450 with or without anlotinib as maintenance treatment in subjects with locally advanced/unresectable non-small cell lung cancer that have not progressed after prior concurrent/sequential chemoradiotherapy (R-ALPS): study protocol for a randomized, double-blind, placebo-contr
Dong B, Chen L, Pang Q, Jiang O, et al · · 2024 · cited 2× · PMID 39507039 · DOI 10.21037/tlcr-24-362
Drug development and evidence for lung cancer targeted therapy in Eastern Asia.
Maggie Liu SY, Jin ZY, Deng JY, Zhong SM, et al · · 2024 · cited 2× · PMID 39381018 · DOI 10.1016/j.lanwpc.2024.101090
Revisiting nature of stage III non-small cell lung cancer: Anatomically defined, biologically systemic.
Li G, Zhang X, Fu X, Liu X, et al · · 2026 · PMID 42147374 · DOI 10.21147/j.issn.1000-9604.2026.02.08

Verify or expand the search:

Other trials of TQB2450

Trials testing the same drug.

NCT06222944 — Anlotinib, TQB2450 (PD-L1 Inhibitor), and Albumin-bound Paclitaxel Regimens in the Treatment of GC/GEJA · Phase 2 · not yet recruiting
NCT06109402 — Perioperative Immunotherpay Versus Adjuvant Immunotherapy for Resectable Non-small Cell Lung Cancer · Phase 2 · not yet recruiting
NCT05608785 — Single-center, Multi-cohort Exploratory Phase Ib/II Clinical Study of First-line Treatment of Unresectable Locally Advan · Phase 1, PHASE2 · unknown
NCT04895345 — A Study of TQB2450 in Combination With Intensity-modulated Radiotherapy in Patients With Inoperable Locally Recurrent Na · Phase 2 · completed
NCT04623333 — A Study of TQB2450 Injection in Subjects With PD-L1 Positive Recurrent or Metastatic Cervical Cancer · Phase 2 · unknown

Other recruiting trials for Stage III Non-small-cell Lung Cancer

Currently open trials in the same condition.

NCT04085250 — Study of Nivolumab for Non-Small Cell Lung Cancer (Stage III) Following Neoadjuvant Chemotherapy Plus Nivolumab and Defi · Phase 2 · active not recruiting
NCT03742687 — Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC · NA · recruiting

Other Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials

Trials by the same sponsor.

NCT06990776 — A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects · Phase 2 · withdrawn
NCT06851442 — Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced o · Phase 1, PHASE2 · terminated
NCT06711991 — A Clinical Trial of TQC3927 Powder for Inhalation in Chronic Obstructive Pulmonary Disease · Phase 1 · completed
NCT06672276 — To Evaluate the Pharmacokinetics and Safety of TQD3606 for Injection in Subjects With Renal Insufficiency · Phase 1 · completed
NCT06644417 — Clinical Study of TQA3605 Tablets Combined With Nucleoside (Acid) Analogs (NAs) Drugs Compared With NAs Drugs in the Tre · Phase 2 · completed

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 NCT04325763 (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 Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Last refreshed: 15 March 2022

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/NCT04325763.

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