NCT04691388 is a Phase 2 clinical trial of sintilimab combined with anlotinib in NSCLC, sponsored by Zhejiang Cancer Hospital.

Who is sponsoring NCT04691388?

NCT04691388 is sponsored by Zhejiang Cancer Hospital.

What drugs are being tested in NCT04691388?

Interventions in NCT04691388: sintilimab combined with anlotinib.

Is NCT04691388 still recruiting?

NCT04691388 is currently completed. Last updated 5 December 2024.

Last reviewed 2024-12-05 · How we verify

NCT04691388

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

A Trial of Sintilimab Plus Anlotinib For Metastatic NSCLC After First-Line PD-1 Inhibitor

Completed Phase 2 Last updated 5 December 2024

What this trial tests

Phase 2 trial testing sintilimab combined with anlotinib in NSCLC in 29 participants. Completed in 1 December 2024.

Timeline

1 March 2021

Primary endpoint
4 September 2024

1 December 2024

Quick facts

Lead sponsor	Zhejiang Cancer Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	1 March 2021
Primary completion	4 September 2024
Estimated completion	1 December 2024
Sites	1 location across China

Drugs / interventions tested

sintilimab combined with anlotinib — full drug profile →

Conditions studied

NSCLC — all drugs for NSCLC →

Sponsor

Zhejiang Cancer Hospital

Who can join

Adults 18 to 75, any sex, with NSCLC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The combination of immunocheckpoint inhibitors and anti-angiogenesis therapy has synergistic anti-tumor effect and is a reasonable method to improve the prognosis of patients. Therefore, in this study, it is hoped that sintilimab combined with anlotinib can overcome immunotherapy resistance, improve the efficacy of immunotherapy, and further improve the survival of patients, so as to provide more clinical evidence for the treatment of advanced NSCLC patients with negative driver gene after first-line treatment with anti-PD-1 antibody.

Publications & conference data

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

Failure of Immunotherapy-The Molecular and Immunological Origin of Immunotherapy Resistance in Lung Cancer.
Błach J, Wojas-Krawczyk K, Nicoś M, Krawczyk P. · · 2021 · cited 44× · PMID 34445735 · DOI 10.3390/ijms22169030
Ramucirumab plus atezolizumab in patients with stage IV non-small cell lung cancer previously treated with immune checkpoint inhibitors.
Herzog BH, Waqar SN, Devarakonda S, Ward JP, et al · · 2022 · cited 9× · PMID 36179540 · DOI 10.1016/j.lungcan.2022.09.011
An Open-Label, Single-Arm, Phase II Trial of Sintilimab Plus Anlotinib for Metastatic Non-Small Cell Lung Cancer After First-Line PD-(L)1 Inhibitor.
Shi X, Lin C, Lou L, He Q, et al · · 2025 · cited 3× · PMID 40908570 · DOI 10.1002/cam4.71191

Verify or expand the search:

Other trials of sintilimab combined with anlotinib

Trials testing the same drug.

NCT05460195 — Sintilimab Combined With Anlotinib for Perioperative Non-small Cell Lung Cancer Based on MRD Evaluation · Phase 2 · unknown

Other recruiting trials for NSCLC

Currently open trials in the same condition.

NCT07479277 — Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC · NA · recruiting
NCT07323732 — A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Diseas · Phase 2 · recruiting
NCT07274813 — A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors · EARLY_PHASE1 · recruiting
NCT07325864 — Molecular Phenotyping of Primitive Lung Cancer and Metastatic Site · recruiting
NCT07169552 — HC010 in First-line PD-L1 Positive Advanced NSCLC Patients · Phase 2 · recruiting

Other Zhejiang Cancer Hospital trials

Trials by the same sponsor.

NCT07343479 — Sacituzumab Tirumotecan Plus Third-Generation TKI With/Without Radiotherapy for EGFR-Mutant NSCLC Brain Metastases · Phase 2 · not yet recruiting
NCT07441720 — Safety and Efficacy of Umbilical Cord Blood Therapy for Cancer Therapy-Induced Thrombocytopenia (CTIT) · Phase 2 · recruiting
NCT07416890 — Thiotepa in Combination With Pirtobrutinib (a BTK Inhibitor) and Sintilimab (a PD-1 Inhibitor) for Frail or Relapsed/Ref · Phase 2 · recruiting
NCT07326150 — Construction of a Predictive Model for the Efficacy of Chemoprevention Combined With Targeted Therapy in Pancreatic Canc · active not recruiting
NCT07330544 — A Phase II Clinical Study Evaluating Entinostat With or Without Anlotinib + Fulvestrant for the Treatment of Hormone Rec · Phase 2 · 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 NCT04691388 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Zhejiang Cancer Hospital
Last refreshed: 5 December 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/NCT04691388.

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