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NCT05603013
Vinorelbine Metronomic Chemotherapy Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 for Treatment of Advanced Refractory Non-small Cell Lung Cancer and Breast Cancer(PRaG 6.0)
Phase 2 trial testing Vinorelbine in Carcinoma, Non-Small-Cell Lung in 45 participants. Status unknown.
1 January 2024
Quick facts
| Lead sponsor | Second Affiliated Hospital of Soochow University |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 30 October 2022 |
| Primary completion | 1 January 2024 |
| Estimated completion | 17 October 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Vinorelbine (vinorelbine) — full drug profile →
- Radiotherapy
- PD-1/PD-L1 inhibitor — full drug profile →
- GM-CSF (gm-csf) — full drug profile →
- IL-2 — full drug profile →
Conditions studied
- Carcinoma, Non-Small-Cell Lung — all drugs for Carcinoma, Non-Small-Cell Lung →
- Carcinoma Breast — all drugs for Carcinoma Breast →
Sponsor
Second Affiliated Hospital of Soochow University
Who can join
18 and older, any sex, with Carcinoma, Non-Small-Cell Lung or Carcinoma Breast. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, single-arm, Phase II investigator-initiated trial of vinorelbine metronomic chemotherapy combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2 for treatment of advanced refractory non-small cell lung cancer and breast cancer.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Efficacy and Safety of PRaG Therapy in Elderly Patients with Advanced Malignant Tumors: A Prospective, Multicenter Clinical Study Protocol (PRaG 9.0 Study).
Zhao X, Yang M, Zhang J, Kong Y, et al · · 2025 · PMID 41308040 · DOI 10.1177/15330338251400412
Verify or expand the search:
- PubMed search for NCT05603013
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Carcinoma, Non-Small-Cell Lung
Currently open trials in the same condition.
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- NCT07222566 — Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adu · Phase 3 · recruiting
- NCT07230691 — A Study of Clinical Outcomes in Participants With EGFR Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Real-Wor · recruiting
- NCT07509333 — MDT-Based Umbrella Decision Model for Geriatric Lung Cancer Patients · NA · recruiting
- NCT07180862 — A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants · Phase 1 · recruiting
Other Second Affiliated Hospital of Soochow University trials
Trials by the same sponsor.
- NCT07327411 — Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid Tumors · Phase 2 · not yet recruiting
- NCT07241897 — DPP4 Inhibitor Intervention on Post-stroke Cognitive Impairment in Ischemic Stroke Patients With Type 2 Diabetes · Phase 3 · not yet recruiting
- NCT07267234 — PRaG-1 Plus PRaG Therapy in Advanced Solid Tumors: A Prospective Clinical Trial (PRaG 10.0) · Phase 2 · not yet recruiting
- NCT07095790 — Tirofiban With Sequential Dual Antiplatelet Therapy in Mild Stroke · Phase 4 · recruiting
- NCT07002502 — Immune Modulation With PRaG-1 Treatment · Phase 2 · 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 NCT05603013 (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 Second Affiliated Hospital of Soochow University
- Last refreshed: 2 November 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/NCT05603013.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing