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Clinical Trials in Italy / NCT06448754
Active, not recruiting Phase 2

Volrustomig Priming Regimens Exploratory Phase II Platform Study

NCT06448754 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2024-08-27
Last updated
2026-08-31

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Volrustomig →Carboplatin →Pemetrexed →Ramucirumab →Paclitaxel →

Volrustomig: Participants will receive volrustomig via intravenous (IV) infusion.

Carboplatin: Participants will receive carboplatin via IV infusion.

Pemetrexed: Participants will receive pemetrexed via IV infusion.

Ramucirumab: Participants will receive ramucirumab via IV infusion.

Paclitaxel: Participants will receive paclitaxel via IV infusion.

Study summary

Purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of volrustomig in combination with other anticancer drugs in participants with specified solid tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration. * Life expectancy greater than or equal to (\>=) 12 weeks. * Adequate organ and bone marrow function. * Body weight greater than (\>) 35 kilograms (kg) at screening and at randomization. * Histologically or cytologically documented NSQ NSCLC in substudy 1 and SQ or NSQ mNSCLC in substudy 2. * Absence of sensitizing epidermal growth factor receptor (EGFR) mutations. * Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies. * At least one measurable lesion not previously irradiated that can be accurately measured at baseline as \>= 10 millimeter (mm) in the longest diameter. Key Exclusion Criteria: * Spinal cord compression. * History of primary active immunodeficiency. * Active or prior documented autoimmune or inflammatory disorders. * Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. * 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 radiation therapy and study enrollment. * Prior chemotherapy or any other systemic therapy for Stage IV NSCLC. Participants who have received prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for local disease are eligible, provided that progression has occurred greater (\>) 12 months from end of last therapy.

Primary outcome measure(s)

Trial sites (63)

FacilityCityRegionStatus
Research Site Los Angeles California
Research Site Chapel Hill North Carolina
Research Site Beijing China
Research Site Hangzhou China
Research Site Jinan China
Research Site Yantai China
Research Site Zhengzhou China
Research Site Bois-Guillaume France
Research Site Caen France
Research Site Dijon France
Research Site Montpellier France
Research Site Batumi Georgia
Research Site Tbilisi Georgia
Research Site Tbilisi Georgia
Research Site Tbilisi Georgia
Research Site Tbilisi Georgia
Research Site Tbilisi Georgia
Research Site Athens Greece
Research Site Athens Greece
Research Site Elaiones Greece
Research Site Piraeus Greece
Research Site Thessaloniki Greece
Research Site Genoa Italy
Research Site Meldola Italy
Research Site Milan Italy
Research Site Naples Italy
Research Site Orbassano Italy
Research Site Perugia Italy
Research Site Rozzano Italy
Research Site Udine Italy
Research Site Verona Italy
Research Site Kuala Lumpur Malaysia
Research Site Kuching Malaysia
Research Site Perai Malaysia
Research Site Lisbon Portugal
Research Site Lisbon Portugal
Research Site Lisbon Portugal
Research Site Porto Portugal
Research Site Cluj-Napoca Romania
Research Site Craiova Romania

+ 23 more sites — see the full list on the official registry below.

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06448754 on ClinicalTrials.gov ↗ ← All trials in Italy