New drug combo aims to shrink lung tumors in early trial
NCT ID NCT06448754
First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 6 times
Summary
This study tests a new drug called volrustomig combined with other cancer treatments for people with advanced non-small cell lung cancer. The main goals are to check safety and see if tumors shrink. About 180 adults will take part in this early-stage trial.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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194 people
The number who actually took part.
- Started
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Aug 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 130 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Los Angeles, California, 90067, United States
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Research Site
Chapel Hill, North Carolina, 27514, United States
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Research Site
Beijing, 100730, China
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Research Site
Hangzhou, 310014, China
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Research Site
Jinan, 250013, China
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Research Site
Yantai, 264000, China
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Research Site
Zhengzhou, 450000, China
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Research Site
Bois-Guillaume, 76031, France
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Research Site
Caen, 14076, France
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Research Site
Dijon, 21079, France
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Research Site
Montpellier, 34070, France
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Research Site
Batumi, 6010, Georgia
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Research Site
Tbilisi, '0159, Georgia
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Research Site
Tbilisi, 0112, Georgia
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Research Site
Tbilisi, 0114, Georgia
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Research Site
Tbilisi, 0144, Georgia
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Research Site
Tbilisi, 186, Georgia
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Research Site
Athens, 115 27, Greece
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Research Site
Athens, 12462, Greece
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Research Site
Elaiones, 546 23, Greece
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Research Site
Piraeus, 185 47, Greece
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Research Site
Thessaloniki, 57001, Greece
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Research Site
Genoa, 16132, Italy
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Research Site
Meldola, 47014, Italy
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Research Site
Milan, 20133, Italy
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Research Site
Naples, 80131, Italy
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Research Site
Orbassano, 10043, Italy
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Research Site
Perugia, 06132, Italy
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Research Site
Rozzano, 20089, Italy
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Research Site
Udine, 33100, Italy
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Research Site
Verona, 37134, Italy
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Research Site
Kuala Lumpur, 59100, Malaysia
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Research Site
Kuching, 93586, Malaysia
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Research Site
Perai, 13700, Malaysia
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Research Site
Lisbon, 1169-050, Portugal
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Research Site
Lisbon, 1400-038, Portugal
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Research Site
Lisbon, 1649-035, Portugal
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Research Site
Porto, 4099-001, Portugal
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Research Site
Cluj-Napoca, 400641, Romania
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Research Site
Craiova, 200542, Romania
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Research Site
Floreşti, 407280, Romania
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Research Site
Belgrade, 11000, Serbia
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Research Site
Seongnam, 13620, South Korea
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Research Site
Seoul, 03722, South Korea
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Research Site
Suwon, 16247, South Korea
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Research Site
A Coruña, 15009, Spain
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Research Site
Alcorcón, 28922, Spain
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Research Site
Barcelona, 08041, Spain
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Research Site
Madrid, 28041, Spain
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Research Site
Málaga, 29004, Spain
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Research Site
Pamplona, 31008, Spain
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Research Site
Santander, 39008, Spain
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Research Site
Santiago de Compostela, 15706, Spain
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Research Site
Valencia, 46015, Spain
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Research Site
Valencia, 46026, Spain
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Research Site
Geneva, 1205, Switzerland
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Research Site
Lausanne, 1011, Switzerland
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Research Site
Winterthur, 8401, Switzerland
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Research Site
Zurich, 8091, Switzerland
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Research Site
Changhua, 50006, Taiwan
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Research Site
New Taipei City, 23561, Taiwan
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Research Site
Taipei, 106, Taiwan
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Research Site
Taipei, 110, Taiwan
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Other studies related to the condition(s) this trial covers.
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