Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
152 participants
INTERVENTIONAL
2025-11-24
2029-02-23
Brief Summary
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Detailed Description
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The study will include sub-studies (sub-study 1 and sub-study 2) and each sub-study focused on a specific treatment may include 2 parts -
1. Part A consisting of one of more safety run-in cohorts to evaluate 2 or more dose levels to identify the recommended Phase 2 dose (RP2D) unless RP2D has been established then Part A will not be required; and
2. Part B consisting of one or more expansion cohorts.
Sub-study 1 will investigate the safety, tolerability, and anti-tumour activity of combination of rilvegostomig and AB248.
Sub-study 2 will evaluate the safety, tolerability, and anti-tumour activity of rilvegostomig plus standard of care (SoC) platinum-based chemotherapy, with or without ramucirumab.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Sub study 1 Part A: Safety run-in
Participants will receive AB248 in combination with rilvegostomig to identify the RP2D to futher evaluate the combination in Part B.
Rilvegostomig
Rilvegostomig will be administered as an intravenous (IV) infusion.
AB248
AB248 will be administered via syringe or an IV bag.
Sub study 1 Part B: Dose expansion
Participants with squamous and non-squamous NSCLC (programmed death-ligand 1 \[PD-L1\] ≥ 50% and PD-L1 1-49%) will receive AB248 in combination with rilvegostomig based on the RP2D determined in Part A.
Rilvegostomig
Rilvegostomig will be administered as an intravenous (IV) infusion.
AB248
AB248 will be administered via syringe or an IV bag.
Sub study 2 Part A: Safety run-in
Participants with squamous and non-squamous NSCLC will receive combination therapy of rilvegostomig, ramucirumab, and platinum-based chemotherapy to assess the safety and tolerability of this regimen.
Rilvegostomig
Rilvegostomig will be administered as an intravenous (IV) infusion.
Cisplatin
Cisplatin will be administered as SoC as an IV infusion.
Carboplatin
Carboplatin will be administered as SoC as an IV infusion.
Pemetrexed
Pemetrexed will be administered as SoC as an IV infusion.
Paclitaxel
Paclitaxel will be administered as SoC as an IV infusion.
Nab-paclitaxel
Nab-paclitaxel will be administered as SoC as an IV infusion.
Ramucirumab
Ramucirumab will be administered as an IV infusion.
Sub study 2 Part B: Dose expansion
Participants will be randomised 1:1 into one of 2 treatment arms (rilvegostomig + chemotherapy + ramucirumab OR rilvegostomig + chemotherapy) in non-squamous histology cohorts and into a single arm (rilvegostomig + chemotherapy+ ramucirumab) in squamous histology cohorts.
Rilvegostomig
Rilvegostomig will be administered as an intravenous (IV) infusion.
Cisplatin
Cisplatin will be administered as SoC as an IV infusion.
Carboplatin
Carboplatin will be administered as SoC as an IV infusion.
Pemetrexed
Pemetrexed will be administered as SoC as an IV infusion.
Paclitaxel
Paclitaxel will be administered as SoC as an IV infusion.
Nab-paclitaxel
Nab-paclitaxel will be administered as SoC as an IV infusion.
Ramucirumab
Ramucirumab will be administered as an IV infusion.
Interventions
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Rilvegostomig
Rilvegostomig will be administered as an intravenous (IV) infusion.
AB248
AB248 will be administered via syringe or an IV bag.
Cisplatin
Cisplatin will be administered as SoC as an IV infusion.
Carboplatin
Carboplatin will be administered as SoC as an IV infusion.
Pemetrexed
Pemetrexed will be administered as SoC as an IV infusion.
Paclitaxel
Paclitaxel will be administered as SoC as an IV infusion.
Nab-paclitaxel
Nab-paclitaxel will be administered as SoC as an IV infusion.
Ramucirumab
Ramucirumab will be administered as an IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Provision of acceptable archival tumour tissue (or fresh tumour tissue biopsy if archival tumour tissue is not available and if clinically feasible) is mandatory at screening.
* Measurable disease as defined by at least one lesion that can be accurately measured at baseline as ≥ 10 mm at the longest diameter.
* Minimum life expectancy of 12 weeks in the opinion of the investigator.
* Adequate organ and marrow function.
* Contraceptive use by male or female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Adequate organ and marrow function and minimum body weight of 30 Kg.
* PD-L1 tumour proportion score (TPS) ≥ 1% (per local report).
\- Adequate coagulation and urinalysis.
Exclusion Criteria
* Any severe or uncontrolled systemic diseases, including uncontrolled hypertension, and active bleeding diseases, ongoing or active known infection; serious chronic gastrointestinal conditions associated with diarrhoea, active non-infectious skin disease or substance abuse.
* Has had a prior stem cell, bone marrow, allogenic tissue, or solid organ transplant.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.
* History of clinically significant arrhythmia, cardiomyopathy of any aetiology or symptomatic congestive heart failure.
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention or presence of small cell and neuroendocrine histology components.
* Unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy, spinal cord compression or symptomatic brain metastases.
* Any prior systemic therapy received for advanced or mNSCLC or treatment with any other anti-cancer agents or immunosuppressive medication.
* Palliative radiotherapy with a limited field of radiation within 2 weeks or with a wide field of radiation or to more than 30% of the bone marrow within 4 weeks, prior to the first dose of study intervention.
* Active tuberculosis infection.
* Any prior exposure to an anti-T-cell immunoreceptor with Ig and Immunoreceptor Tyrosine-based Inhibition Motif (ITIM) domains (TIGIT) therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
* Any prior systemic treatment with an immune-oncology agent, including but not limited to anti-PD-1, anti-PD-L1, anti-Cytotoxic T-lymphocyte Associated Antigen 4 (CTLA-4).
* Has a known history of human immunodeficiency virus (HIV) infection.
* Has either a known history of Hepatitis B virus (HBV) or has active Hepatitis C virus (HCV).
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis/interstitial lung disease.
* Any concomitant medication known to be associated with Torsades de pointes.
* Known active hepatitis A.
* Acute hepatitis B infection (anti-hepatitis B core antibody \[HBc\] immunoglobulin M \[IgM\] positive) or chronic hepatitis B infection with HBV DNA ≥ 2000 IU/mL.
* Active hepatitis C infection (anti-HCV positive with HCV RNA detectable) or anti- HCV positive with HCV RNA undetectable for less than 12 weeks following treatment for HCV.
* Known HIV infection that is not well controlled.
* Evidence of Grade ≥ 1 central nervous system (CNS) haemorrhage.
* Uncontrolled arterial hypertension ≥ 150 and/or ≥ 100 mm Hg.
* Radiographic evidence of major blood vessel invasion or encasement by cancer, intratumour cavitation or direct tumour penetration into the trachea or bronchus.
* Has experienced any arterial thrombotic event, a Grade ≥ 3 bleeding event or has gross haemoptysis.
* Has significant bleeding disorders, serious or nonhealing wound, ulcer or clinically relevant congestive heart failure.
* Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection.
* Under chronic therapy with antiplatelet agents.
* Any prior exposure to anti-vascular endothelial growth factor (VEGF) therapy.
* Known allergy or hypersensitivity to rilvegostomig or any of the excipients of rilvegostomig, cisplatin, carboplatin, paclitaxel or nab-paclitaxel or pemetrexed or ramucirumab.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Phoenix, Arizona, United States
Research Site
Santa Rosa, California, United States
Research Site
Jacksonville, Florida, United States
Research Site
Baltimore, Maryland, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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Cleveland, Ohio, United States
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Providence, Rhode Island, United States
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Tyler, Texas, United States
Research Site
Anderlecht, , Belgium
Research Site
Hasselt, , Belgium
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Leuven, , Belgium
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Barretos, , Brazil
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Fortaleza, , Brazil
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Natal, , Brazil
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Pelotas, , Brazil
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Porto Alegre, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Chengdu, , China
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Chongqing, , China
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Deyang, , China
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Fuzhou, , China
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Guangzhou, , China
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Jinan, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Shenzhen, , China
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Wuhan, , China
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Wuhan, , China
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Bordeaux, , France
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Dijon, , France
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Limoges, , France
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Marseille, , France
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Nantes, , France
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Nice, , France
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Paris, , France
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Batumi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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München, , Germany
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Münster, , Germany
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Oldenburg, , Germany
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Regensburg, , Germany
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Würzburg, , Germany
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Milan, , Italy
Research Site
Milan, , Italy
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Orbassano, , Italy
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Pavia, , Italy
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Roma, , Italy
Research Site
Bunkyō City, , Japan
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Bunkyō City, , Japan
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Kashiwa, , Japan
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Kurume-shi, , Japan
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Kyoto, , Japan
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Niigata, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Toyoake-shi, , Japan
Research Site
Kuala Lumpur, , Malaysia
Research Site
Kuala Selangor, , Malaysia
Research Site
Kuching, , Malaysia
Research Site
Singapore, , Malaysia
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Chisinau, , Moldova
Research Site
Amsterdam, , Netherlands
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Groningen, , Netherlands
Research Site
Leiden, , Netherlands
Research Site
Lima, , Peru
Research Site
Koszalin, , Poland
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Lodz, , Poland
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Olsztyn, , Poland
Research Site
Belgrade, , Serbia
Research Site
Kragujevac, , Serbia
Research Site
Niš, , Serbia
Research Site
Seongbuk-Gu, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
L'Hospitalet de Llobregat, , Spain
Research Site
Madrid, , Spain
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Madrid, , Spain
Research Site
Pamplona, , Spain
Research Site
Pozuelo de Alarcón, , Spain
Research Site
Valencia, , Spain
Research Site
Valencia, , Spain
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Bangkok, , Thailand
Research Site
Chanthaburi, , Thailand
Research Site
Hat Yai, , Thailand
Research Site
Khon Kaen, , Thailand
Research Site
Rachathewi, , Thailand
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Fatih, , Turkey (Türkiye)
Research Site
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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2024-519786-22
Identifier Type: OTHER
Identifier Source: secondary_id
D702KC00001
Identifier Type: -
Identifier Source: org_study_id