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New treatment option for Non-small Cell Lung Cancer
Official title Volrustomig Priming Regimens Exploratory Phase II Platform Study
ClinicalTrials.gov ID: NCT06448754
What this study is testing
What is Volrustomig?
Volrustomig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as MEDI5752.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 130
You may be able to join if
- 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.
You likely can't join if
- 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...
- Prior chemotherapy or any other systemic therapy for Stage IV NSCLC. Participants who have received prior platinum-containing adjuvant, neoadjuvant...
See the full eligibility 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Grand Junction, Colorado, United States
- Wheat Ridge, Colorado, United States
- Baltimore, Maryland, United States
- Detroit, Michigan, United States
- Chapel Hill, North Carolina, United States
- Tacoma, Washington, United States
- Montreal, Quebec, Canada
- Beijing, China
- Hangzhou, China
- Jinan, China
- Yantai, China
- Zhengzhou, China
- Bois-Guillaume, France
- Caen, France
- Créteil, France
- Dijon, France
- Montpellier, France
- Batumi, Georgia
- Tbilisi, Georgia
+ 44 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 130 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Grand Junction, Colorado, United States; Wheat Ridge, Colorado, United States; Baltimore, Maryland, United States; Detroit, Michigan, United States; Chapel Hill, North Carolina, United States and 58 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.