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)
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — From screening (Days -28 to Day -1) up to 2 year 10 months The safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors will be assessed.
Confirmed Objective Response rate (ORR) — Up to 2 year 10 months ORR is defined as the percentage of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
Trial sites (63)
Facility
City
Region
Status
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.
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.
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