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New Dual-Action drug shows promise in early lung cancer trial

NCT ID NCT04995523

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Updated 2 times

Summary

This study tests a new drug called rilvegostomig (AZD2936) in people with advanced or metastatic non-small cell lung cancer. The drug is designed to boost the immune system's ability to fight cancer by blocking two targets (TIGIT and PD-1). The trial will check for safety, side effects, and whether the drug can shrink tumors. About 212 participants will take part in this early-stage research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rilvegostomig (AZD2936), a bispecific antibody that targets two immune checkpoints (TIGIT and PD-1)
What this could lead to
If successful, this could provide a new treatment option for advanced lung cancer by helping the immune system attack cancer cells more effectively.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so safety and effectiveness are not yet proven. The drug may cause immune-related side effects or not work for all patients.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

212 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Jun 2028

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.

Inclusion Criteria: * Written informed consent * Aged 18 or above * Part A and Part B: Unresectable stage III or stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part C and Part D: Stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part E: Stage IV squamous NSCLC not amenable to curative surgery or radiation. * Documented PD-L1 expression by PD-L1 IHC per local report. * Part A and Part B: Confirmed progression during treatment with a CPI-including regimen. * Part C and Part D: No prior I/O treatment for metastatic NSCLC. * Part E: No prior treatment for metastatic NSCLC. * ECOG performance status of 0 or 1 at enrolment. * Life expectancy of ≥ 12 weeks at enrolment. * Have at least 1 measurable lesion per RECIST v1.1. * Adequate bone marrow, liver and kidney function Exclusion Criteria: * Sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusion * Documented test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care (e.g. ROS1, NTRK fusions, BRAF, V600E mutation) * Previous treatment with an anti-TIGIT therapy * Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment. * Part A and Part B: Primary or secondary resistance after treatment with 2 or more regiments including a CPI. * Part C and Part D: Any prior systemic treatment with an immune oncology agent (prior administration of immune-oncology agent for curative intent to treat other invasive malignancy is permitted). Treatment with one previous systemic chemotherapy will be allowed. * Part E: Any prior systemic treatment for metastatic NSCLC, including but not limited to chemotherapy, anti-PD-1, anti-PD-L1, anti-CTLA-4. * Symptomatic central nervous system (CNS) metastasis. * Thromboembolic event within 3 months prior to enrolment. * Other invasive malignancy within 2 years prior to screening.

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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

    Chicago, Illinois, 60637, United States

  • Research Site

    Rochester, Minnesota, 55905, United States

  • Research Site

    Fairfax, Virginia, 22031, United States

  • Research Site

    Melbourne, 3000, Australia

  • Research Site

    Anderlecht, 1070, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Florianópolis, 88034-000, Brazil

  • Research Site

    Natal, 59075-740, Brazil

  • Research Site

    Porto Alegre, 90035903, Brazil

  • Research Site

    Rio de Janeiro, 20231-050, Brazil

  • Research Site

    São Paulo, 01246-000, Brazil

  • Research Site

    Chengdu, 610041, China

  • Research Site

    Chongqing, 400030, China

  • Research Site

    Copenhagen, 2100, Denmark

  • Research Site

    Dijon, 21079, France

  • Research Site

    Toulouse, 31059, France

  • Research Site

    Tbilisi, 0112, Georgia

  • Research Site

    Kashiwa, 227-8577, Japan

  • Research Site

    Niigata, 951-8566, Japan

  • Research Site

    Sendai, 981-0914, Japan

  • Research Site

    Tokyo, 104-0045, Japan

  • Research Site

    Kuala Lumpur, 59100, Malaysia

  • Research Site

    Kuching, 93586, Malaysia

  • Research Site

    Chisinau, MD-2025, Moldova

  • Research Site

    Groningen, 9713 GZ, Netherlands

  • Research Site

    Leiden, 2333 ZA, Netherlands

  • Research Site

    Utrecht, 3584 CX, Netherlands

  • Research Site

    Seoul, 03082, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Barcelona, 08035, Spain

  • Research Site

    Madrid, 28027, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Taichung, 40201, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Tainan, 70403, Taiwan

  • Research Site

    Taipei, 110, Taiwan

  • Research Site

    Bangkok, 10700, Thailand

  • Research Site

    Chanthaburi, 22000, Thailand

  • Research Site

    Muang, 50200, Thailand

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