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New drug combo aims to shrink lung tumors in early trial

NCT ID NCT06448754

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

194 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 130 years

Sex

Anyone

Healthy volunteers

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

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

  • Research Site

    Los Angeles, California, 90067, United States

  • Research Site

    Chapel Hill, North Carolina, 27514, United States

  • Research Site

    Beijing, 100730, China

  • Research Site

    Hangzhou, 310014, China

  • Research Site

    Jinan, 250013, China

  • Research Site

    Yantai, 264000, China

  • Research Site

    Zhengzhou, 450000, China

  • Research Site

    Bois-Guillaume, 76031, France

  • Research Site

    Caen, 14076, France

  • Research Site

    Dijon, 21079, France

  • Research Site

    Montpellier, 34070, France

  • Research Site

    Batumi, 6010, Georgia

  • Research Site

    Tbilisi, '0159, Georgia

  • Research Site

    Tbilisi, 0112, Georgia

  • Research Site

    Tbilisi, 0114, Georgia

  • Research Site

    Tbilisi, 0144, Georgia

  • Research Site

    Tbilisi, 186, Georgia

  • Research Site

    Athens, 115 27, Greece

  • Research Site

    Athens, 12462, Greece

  • Research Site

    Elaiones, 546 23, Greece

  • Research Site

    Piraeus, 185 47, Greece

  • Research Site

    Thessaloniki, 57001, Greece

  • Research Site

    Genoa, 16132, Italy

  • Research Site

    Meldola, 47014, Italy

  • Research Site

    Milan, 20133, Italy

  • Research Site

    Naples, 80131, Italy

  • Research Site

    Orbassano, 10043, Italy

  • Research Site

    Perugia, 06132, Italy

  • Research Site

    Rozzano, 20089, Italy

  • Research Site

    Udine, 33100, Italy

  • Research Site

    Verona, 37134, Italy

  • Research Site

    Kuala Lumpur, 59100, Malaysia

  • Research Site

    Kuching, 93586, Malaysia

  • Research Site

    Perai, 13700, Malaysia

  • Research Site

    Lisbon, 1169-050, Portugal

  • Research Site

    Lisbon, 1400-038, Portugal

  • Research Site

    Lisbon, 1649-035, Portugal

  • Research Site

    Porto, 4099-001, Portugal

  • Research Site

    Cluj-Napoca, 400641, Romania

  • Research Site

    Craiova, 200542, Romania

  • Research Site

    Floreşti, 407280, Romania

  • Research Site

    Belgrade, 11000, Serbia

  • Research Site

    Seongnam, 13620, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Suwon, 16247, South Korea

  • Research Site

    A Coruña, 15009, Spain

  • Research Site

    Alcorcón, 28922, Spain

  • Research Site

    Barcelona, 08041, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Málaga, 29004, Spain

  • Research Site

    Pamplona, 31008, Spain

  • Research Site

    Santander, 39008, Spain

  • Research Site

    Santiago de Compostela, 15706, Spain

  • Research Site

    Valencia, 46015, Spain

  • Research Site

    Valencia, 46026, Spain

  • Research Site

    Geneva, 1205, Switzerland

  • Research Site

    Lausanne, 1011, Switzerland

  • Research Site

    Winterthur, 8401, Switzerland

  • Research Site

    Zurich, 8091, Switzerland

  • Research Site

    Changhua, 50006, Taiwan

  • Research Site

    New Taipei City, 23561, Taiwan

  • Research Site

    Taipei, 106, Taiwan

  • Research Site

    Taipei, 110, Taiwan

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