New Dual-Action drug shows promise in early lung cancer trial
NCT ID NCT04995523
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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212 people
The number who actually took part.
- Started
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Sep 2021
- Expected to finish
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Jun 2028
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.
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
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Research Site
Chicago, Illinois, 60637, United States
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Research Site
Rochester, Minnesota, 55905, United States
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Research Site
Fairfax, Virginia, 22031, United States
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Research Site
Melbourne, 3000, Australia
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Research Site
Anderlecht, 1070, Belgium
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Research Site
Leuven, 3000, Belgium
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Research Site
Florianópolis, 88034-000, Brazil
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Research Site
Natal, 59075-740, Brazil
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Research Site
Porto Alegre, 90035903, Brazil
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Research Site
Rio de Janeiro, 20231-050, Brazil
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Research Site
São Paulo, 01246-000, Brazil
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Research Site
Chengdu, 610041, China
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Research Site
Chongqing, 400030, China
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Research Site
Copenhagen, 2100, Denmark
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Research Site
Dijon, 21079, France
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Research Site
Toulouse, 31059, France
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Research Site
Tbilisi, 0112, Georgia
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Research Site
Kashiwa, 227-8577, Japan
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Research Site
Niigata, 951-8566, Japan
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Research Site
Sendai, 981-0914, Japan
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Research Site
Tokyo, 104-0045, Japan
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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
Chisinau, MD-2025, Moldova
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Research Site
Groningen, 9713 GZ, Netherlands
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Research Site
Leiden, 2333 ZA, Netherlands
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Research Site
Utrecht, 3584 CX, Netherlands
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Research Site
Seoul, 03082, South Korea
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Research Site
Seoul, 03722, South Korea
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Research Site
Seoul, 05505, South Korea
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Research Site
Barcelona, 08035, Spain
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Research Site
Madrid, 28027, Spain
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Research Site
Madrid, 28041, Spain
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Research Site
Taichung, 40201, Taiwan
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Research Site
Taichung, 40705, Taiwan
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Research Site
Tainan, 70403, Taiwan
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Research Site
Taipei, 110, Taiwan
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Research Site
Bangkok, 10700, Thailand
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Research Site
Chanthaburi, 22000, Thailand
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Research Site
Muang, 50200, Thailand
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a targeted pill keep lung cancer from returning?
- Seeing Cancer's hidden markers: a new PET tracer could reveal who responds to targeted therapy
- Lab-Made immune protein takes on advanced cancers in first human test
- Experimental combo for lung cancer shows promise but study cut short
- New study tracks how well a targeted lung cancer drug works in everyday clinics
- New 4D scan could sharpen lung cancer radiation