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NCT04167657: STAR
SinTilimab After Radiation (STAR Study)
Phase 2 trial testing Sintilimab in Carcinoma, Non-Small Cell Lung in 14 participants. Completed in 30 April 2024.
30 November 2023
Quick facts
| Lead sponsor | Peking Union Medical College Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 15 April 2019 |
| Primary completion | 30 November 2023 |
| Estimated completion | 30 April 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Sintilimab — full drug profile →
Conditions studied
- Carcinoma, Non-Small Cell Lung — all drugs for Carcinoma, Non-Small Cell Lung →
Sponsor
Peking Union Medical College Hospital
Who can join
18 and older, any sex, with Carcinoma, Non-Small Cell Lung. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a single-arm multi-center phase II clinical study, which aims to investigate the efficacy and safety of sintilimab after radiotherapy in patients with advanced NSCLC who failed first-line or second-line systemic treatment.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Radiotherapy combined with immunotherapy: the dawn of cancer treatment.
Zhang Z, Liu X, Chen D, Yu J. · · 2022 · cited 463× · PMID 35906199 · DOI 10.1038/s41392-022-01102-y -
Optimizing the Treatment Schedule of Radiotherapy Combined With Anti-PD-1/PD-L1 Immunotherapy in Metastatic Cancers.
Kong Y, Ma Y, Zhao X, Pan J, et al · · 2021 · cited 34× · PMID 33859942 · DOI 10.3389/fonc.2021.638873 -
Molecular and Clinical Premises for the Combination Therapy Consisting of Radiochemotherapy and Immunotherapy in Non-Small Cell Lung Cancer Patients.
Frąk M, Krawczyk P, Kalinka E, Milanowski J. · · 2021 · cited 9× · PMID 33799560 · DOI 10.3390/cancers13061222 -
Safety and Efficacy of Radiotherapy Combined With Sintilimab in Advanced NSCLC Patients Who Progressed on First or Second Line Therapy: A Prospective, Multiple Center, and Single-Arm Study.
Feng X, Liu X, Guan H, Chen C, et al · · 2025 · cited 1× · PMID 40116232 · DOI 10.1111/1759-7714.70043 -
The characteristics of oncological clinical trials investigating the synergistic effect of radiotherapy and immune checkpoint inhibitors: a cross-sectional study.
Chen L, Xu W, Qi WX, Xu F. · · 2023 · cited 1× · PMID 37033350 · DOI 10.21037/tcr-22-1151 -
Immunotherapy combined with radiotherapy for advanced non-small cell lung cancer: Current status and challenge (Review).
Li Q, Cai YQ, Shao LH, Qi YX, et al · · 2025 · PMID 40799300 · DOI 10.3892/ol.2025.15215
Verify or expand the search:
- PubMed search for NCT04167657
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 Carcinoma, Non-Small Cell Lung
Currently open trials in the same condition.
- NCT07227298 — Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer · Phase 1, PHASE2 · recruiting
- NCT06868277 — A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic · Phase 3 · recruiting
- NCT05358249 — Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation · Phase 1, PHASE2 · active not recruiting
- NCT04389632 — A Study of Sigvotatug Vedotin in Advanced Solid Tumors · Phase 1 · recruiting
Other Peking Union Medical College Hospital trials
Trials by the same sponsor.
- NCT07466251 — PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke · Phase 4 · not yet recruiting
- NCT06743321 — Speech-to-speech Voice-cloning Care (SVCC) to Improve ICU-acquired Anxiety for Critically Ill Patients · NA · not yet recruiting
- NCT07590336 — 68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma · Phase 1, PHASE2 · not yet recruiting
- NCT07515976 — Mapping of Genomic Structural Variations in Major Birth Defects · not yet recruiting
- NCT07386756 — Early Precise Identification and Intervention Strategies for Individuals at High Risk of Prediabetes · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04167657 (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 Peking Union Medical College Hospital
- Last refreshed: 19 September 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/NCT04167657.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing