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NCT04507217
Tislelizumab Combined With Pemetrexed/ Carboplatin in Patients With Brain Metastases of Non-squamous NSCLC
Phase 2 trial testing Tislelizumab, Carboplatin, Pemetrexed in NSCLC Stage IV in 36 participants. Completed in 30 January 2023.
15 November 2022
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 15 September 2020 |
| Primary completion | 15 November 2022 |
| Estimated completion | 30 January 2023 |
| Sites | 2 locations across China |
Drugs / interventions tested
- Tislelizumab, Carboplatin, Pemetrexed — full drug profile →
Conditions studied
- NSCLC Stage IV — all drugs for NSCLC Stage IV →
- Brain Metastases — all drugs for Brain Metastases →
- PD-1 Antibody — all drugs for PD-1 Antibody →
Sponsor
Sun Yat-sen University
Who can join
Adults 18 to 75, any sex, with NSCLC Stage IV or Brain Metastases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a phase II, Open-Label, Multicenter, Prospective Clinical Study to Investigate the Efficacy and Safety of Tislelizumab Combined with Pemetrexed/ Carboplatin in Patients with Brain Metastases of Non-squamous Non-small Cell Lung Cancer. The primary end point is PFS, and secondary endpoint is ORR, OS, DoR and Neurocognitive impairment. during the study, the exploratory objectives including (1) PD-L1 expression, TMB, and other potential predictive biomarkers, correlated with response to treatment (2) Progression-free survival based on intracranial response (iPFS) according to RECIST 1.1 and RANO-BM
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Exploring the Molecular Tumor Microenvironment and Translational Biomarkers in Brain Metastases of Non-Small-Cell Lung Cancer.
Wen J, Yu JZ, Liu C, Ould Ismail AAO, et al · · 2024 · cited 13× · PMID 38396722 · DOI 10.3390/ijms25042044 -
Progress in personalized immunotherapy for patients with brain metastasis.
Patel L, Kolundzic N, Abedalthagafi M. · · 2025 · cited 9× · PMID 39880875 · DOI 10.1038/s41698-025-00812-0 -
Intracranial response pattern, tolerability and biomarkers associated with brain metastases in non-small cell lung cancer treated by tislelizumab plus chemotherapy.
Zhao S, Jiang W, Yang N, Liu L, et al · · 2024 · cited 7× · PMID 38496686 · DOI 10.21037/tlcr-23-687 -
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 -
Synergy of radiotherapy, focused ultrasound, and immunotherapy in the treatment of brain metastases.
Boffelli L, Fimiani C, Núñez NG, Kienzler JC. · · 2025 · PMID 41396538 · DOI 10.1007/s11060-025-05379-1
Verify or expand the search:
- PubMed search for NCT04507217
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for NSCLC Stage IV
Currently open trials in the same condition.
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Other Sun Yat-sen University trials
Trials by the same sponsor.
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- NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
- NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
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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 NCT04507217 (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 Sun Yat-sen University
- Last refreshed: 25 May 2023
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/NCT04507217.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing