NCT04180501 is a Phase 2 clinical trial of SRS sequential sintilimab in NSCLC Stage IV, sponsored by Xiaorong Dong.

Who is sponsoring NCT04180501?

NCT04180501 is sponsored by Xiaorong Dong.

What drugs are being tested in NCT04180501?

Interventions in NCT04180501: SRS sequential sintilimab.

What condition does NCT04180501 study?

NCT04180501 studies NSCLC Stage IV, Brain Metastases, SRS, Sintilimab.

Is NCT04180501 still recruiting?

NCT04180501 is currently status unknown. Last updated 26 November 2019.

Last reviewed 2019-11-26 · How we verify

NCT04180501

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

A Phase II Study on the Treatment of Advanced Non-small Cell Lung Cancer With Brain Metastasis by SRS Sequential Sintilimab

Status unknown Phase 2 Last updated 26 November 2019

What this trial tests

Phase 2 trial testing SRS sequential sintilimab in NSCLC Stage IV in 25 participants. Status unknown.

Timeline

1 November 2019

Primary endpoint
1 September 2021

1 December 2021

Quick facts

Lead sponsor	Xiaorong Dong
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	1 November 2019
Primary completion	1 September 2021
Estimated completion	1 December 2021
Sites	1 location across China

Drugs / interventions tested

SRS sequential sintilimab

Conditions studied

NSCLC Stage IV — all drugs for NSCLC Stage IV →
Brain Metastases — all drugs for Brain Metastases →
SRS — all drugs for SRS →
Sintilimab — all drugs for Sintilimab →

Sponsor

Xiaorong Dong — full company profile →

Who can join

Adults 18 to 70, any sex, with NSCLC Stage IV or Brain Metastases. 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.

iPFSof NSCLC patients receiving SRS sequential sintilimab
Time frame: 1 year
From the beginning of treatment to the end of follow-up study, when the longest diameter of brain metastases treated by SRS was more than 30% smaller than the baseline level at any time of efficacy evaluation, the objective remission of the lesions was achieved. The time from the objective remission to the next progress of the intracranial lesions was recorded as the intracranial progression-free

Sponsor's own description

A phase II study on the treatment of advanced non-small cell lung cancer with brain metastasis by SRS sequential sintilimab

Publications & conference data

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

Modern Radiation Therapy for the Management of Brain Metastases From Non-Small Cell Lung Cancer: Current Approaches and Future Directions.
Mantovani C, Gastino A, Cerrato M, Badellino S, et al · · 2021 · cited 37× · PMID 34796118 · DOI 10.3389/fonc.2021.772789
The Role of Microglia in Brain Metastases: Mechanisms and Strategies.
Feng Y, Hu X, Zhang Y, Wang Y. · · 2024 · cited 27× · PMID 37307835 · DOI 10.14336/ad.2023.0514
Radiotherapy combined with PD-1/PD-L1 inhibitors in NSCLC brain metastases treatment: The mechanisms, advances, opportunities, and challenges.
Chen ZY, Duan XT, Qiao SM, Zhu XX. · · 2023 · cited 10× · PMID 35986515 · DOI 10.1002/cam4.5016
The Strategies and Mechanisms of Immune Checkpoint Inhibitors for Brain Metastases in NSCLC.
Li J, Wang M, Xu S, Li Y, et al · · 2022 · cited 7× · PMID 35656295 · DOI 10.3389/fphar.2022.841623
Oligometastatic Disease in Non-Small-Cell Lung Cancer: An Update.
Chen YH, Ho UC, Kuo LT. · · 2022 · cited 6× · PMID 35267658 · DOI 10.3390/cancers14051350

Verify or expand the search:

Other recruiting trials for NSCLC Stage IV

Currently open trials in the same condition.

NCT07279402 — TRIMPACT: Real-World First-Line Atezolizumab Use in Stage IV NSCLC With PD-L1 ≥50% · recruiting
NCT06401824 — Sacituzumab Govitecan and Bevacizumab for NSCLC Brain Metastases · Phase 2 · recruiting
NCT06532149 — ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer · recruiting
NCT06313541 — Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunothera · Phase 2 · recruiting
NCT06788366 — AI-HOPE Lung Cancer: Building a Predictive Tool for Metastatic Lung Cancer · recruiting

Other Xiaorong Dong trials

Trials by the same sponsor.

NCT05737589 — Circulating Tumor DNA and T Cell Repertoire Predict Radiotherapeutic Outcomes in NSCLC Patients With Brain Metastasis · unknown
NCT05738317 — Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel in Non-squamous NSCLC After First-line Treatment · Phase 2 · unknown
NCT03454685 — The Role of Microbiota on the Development of Lung Cancer · unknown

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 NCT04180501 (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 Xiaorong Dong
Last refreshed: 26 November 2019

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/NCT04180501.

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