A global study of volrustomig (MEDI5752) plus chemotherapy versus pembrolizumab plus chemotherapy for participants with metastatic non-small cell lung cancer.
Key facts
- Where
- Budapest VIII, Budapest XII, Debrecen, Gyongyos, Gyöngyös, Győr, Kecskemét, Pécs, Székesfehérvár, Szekszárd, Torokbalint és Törökbálint, MagyarországSee the 14 sites
- Phase
- 3. fázis
Where in Magyarország
- Semmelweis UniversityBudapest VIII, MagyarországNo longer taking part
- Koranyi National Institute For PulmonologyBudapest XII, MagyarországNo longer taking part
- Orszagos Koranyi Pulmonologiai IntezetBudapest XII, MagyarországNo longer taking part
- Orszagos Onkologiai IntezetBudapest XII, MagyarországNo longer taking part
- University of DebrecenDebrecen, MagyarországNo longer taking part
- Clinexpert Kft.Gyongyos, MagyarországNo longer taking part
- Matrai GyogyintezetGyöngyös, MagyarországNo longer taking part
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato KorhazGyőr, MagyarországNo longer taking part
- Bacs-Kiskun Varmegyei OktatokorhazKecskemét, MagyarországNo longer taking part
- University of PecsPécs, MagyarországNo longer taking part
- Fejér Megyei Szent György Egyetemi Oktató KórházSzékesfehérvár, MagyarországNo longer taking part
- Tolna Megyei Balassa Janos KorhazSzekszárd, MagyarországNo longer taking part
- Toeroekbalinti TuedogyogyintezetTorokbalint, MagyarországNo longer taking part
- Református Pulmonológiai CentrumTörökbálint, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca AB
- Trial code
- EU 2023-503298-39-00
- Record updated
- 2026. október 26.
- Original description
The primary objective of the study is to determine whether volrustomig plus chemotherapy improves PFS and OS when compared with pembrolizumab plus chemotherapy in participants with mNSCLC where PD-L1 < 1%.Read full original descriptionShow less
A Phase III, Two- Arm, Parallel, Randomized, Multi-Center, Open‑Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) in Combination with Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (mNSCLC) (eVOLVE-Lung02)
The primary objective of the study is to determine whether volrustomig plus chemotherapy improves PFS and OS when compared with pembrolizumab plus chemotherapy in participants with mNSCLC where PD-L1 < 1%.
Inclusion: Histologically or cytologically documented squamous or non-squamous NSCLC. Stage IV NSCLC (according to Version 8 of the IASLC Staging; Provision of tumor sample for prospective PD-L1 testing ; PD-L1 <50%; Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation) and ALK and ROS1 rearrangements; Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes (eg, NTRK, BRAF, RET, MET, etc.) for which there are locally approved targeted first-line therapies.
Exclusion: No prior exposure to immunotherapy; Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment; History of another primary malignancy except for: (a) Malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. (b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. (c) Adequately treated carcinoma in situ without evidence of disease; Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare subtypes (eg, NUT carcinoma, thoracic SMARCA4-deficient undifferentiated tumor, adenoid cystic carcinoma, epithelial-myoepithelial carcinoma) are excluded; As judged by the investigator, any condition that would interfere with evaluation of the study intervention or interpretation of participant safety or study results; No medical contraindication to platinum-based treatment; Spinal cord compression.