A Platform Study in Non-Small Cell Lung Cancer (NSCLC)
ALTAIR
A Phase Ib/II Open-Label, Multicentre Platform Study Evaluating Novel Combinations in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer
2 other identifiers
interventional
152
20 countries
104
Brief Summary
The purpose of this study is to assess the safety and efficacy of multiple study interventions including novel-novel combinations or novel agents in combination with standard therapy for the treatment of metastatic NSCLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2025
Typical duration for phase_1
104 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2025
CompletedFirst Posted
Study publicly available on registry
May 30, 2025
CompletedStudy Start
First participant enrolled
November 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 23, 2029
May 1, 2026
April 1, 2026
3.3 years
May 5, 2025
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Part A and Part B: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability and determine RP2D of the combination of novel anti-cancer agents.
Approximately 46 months
Part A: Number of partcipants with dose limiting toxicity (DLT)
To assess the safety and tolerability and determine RP2D of the combination of novel anti-cancer agents.
Approximately 46 months
Part B: Objective response (OR)
The OR is defined as a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR).
Approximately 46 months
Secondary Outcomes (18)
Part A: Objective response (OR)
Approximately 46 months
Part A and Part B: Duration of response (DOR)
Approximately 46 months
Part A and Part B: Time to response (TTR)
Approximately 46 months
Part A and Part B: Disease control (DC)
Approximately 46 months
Part A and Part B: Progression free survival (PFS)
Approximately 46 months
- +13 more secondary outcomes
Study Arms (2)
Sub study 2 Part A: Safety run-in
EXPERIMENTALParticipants 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.
Sub study 2 Part B: Dose expansion
EXPERIMENTALParticipants 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.
Interventions
Rilvegostomig will be administered as an intravenous (IV) infusion.
Cisplatin will be administered as SoC as an IV infusion.
Carboplatin will be administered as SoC as an IV infusion.
Pemetrexed will be administered as SoC as an IV infusion.
Paclitaxel will be administered as SoC as an IV infusion.
Nab-paclitaxel will be administered as SoC as an IV infusion.
Ramucirumab will be administered as an IV infusion.
Eligibility Criteria
You may qualify if:
- Participants with confirmed squamous or non-squamous NSCLC with a current Stage IV mNSCLC.
- 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.
- Programmed death-ligand 1 (PD-L1) tumour proportion score (TPS) ≥ 1% (per local report).
- Adequate coagulation and urinalysis.
- Minimum body weight of 30 kg.
You may not qualify if:
- Participants with epidermal growth factor receptor mutations, anaplastic lymphoma receptor fusions or any other known genomic alteration for which targeted therapy is approved in the first line per local standard of care.
- Presence of small cell and neuroendocrine histology components.
- Any severe or uncontrolled systemic diseases, including uncontrolled hypertension, and active bleeding diseases, ongoing or active known infection; interstitial lung disease/pneumonitis (of any grade); unstable and/or symptomatic venous thromboembolism, 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 5 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.
- Persistent toxicities (common terminology criteria for adverse events \[CTCAE\] ≥ Grade 2) caused by previous anti-cancer therapy, excluding alopecia.
- Spinal cord compression or symptomatic brain metastases.
- 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.
- 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 human immunodeficiency virus (HIV) infection that is not well controlled.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (104)
Research Site
Phoenix, Arizona, 85054, United States
Research Site
Santa Rosa, California, 95403, United States
Research Site
Jacksonville, Florida, 32224, United States
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Baltimore, Maryland, 21201, United States
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Detroit, Michigan, 48202, United States
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Rochester, Minnesota, 55905, United States
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Cleveland, Ohio, 44106, United States
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Providence, Rhode Island, 02903, United States
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Providence, Rhode Island, 02906, United States
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Tyler, Texas, 75708, United States
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Anderlecht, 1070, Belgium
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Hasselt, 3500, Belgium
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Leuven, 3000, Belgium
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Barretos, 14784-400, Brazil
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Fortaleza, 60336-232, Brazil
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Natal, 59075-740, Brazil
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Pelotas, 096015-280, Brazil
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Porto Alegre, 90035-903, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 05651-901, Brazil
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Chengdu, 610041, China
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Chongqing, 400072, China
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Deyang, 618000, China
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Fuzhou, 350014, China
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Guangzhou, 510405, China
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Jinan, 250013, China
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Shanghai, 200433, China
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Shanghai, 201114, China
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Shenyang, 110015, China
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Shenzhen, 518116, China
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Wuhan, 430022, China
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Wuhan, 430060, China
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Bordeaux, 33076, France
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Dijon, 21079, France
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Limoges, 87000, France
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Marseille, 13015, France
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Nantes, 44093, France
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Nice, 06189, France
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Paris, 75005, France
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Batumi, 6010, Georgia
Research Site
Tbilisi, 0112, Georgia
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Tbilisi, 0112, Georgia
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Tbilisi, 0114, Georgia
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Tbilisi, 0144, Georgia
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Tbilisi, 0186, Georgia
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München, 81675, Germany
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Münster, 48149, Germany
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Oldenburg, 26121, Germany
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Regensburg, 93053, Germany
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Würzburg, 97080, Germany
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Milan, 20141, Italy
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Milan, 20162, Italy
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Orbassano, 10043, Italy
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Pavia, 27100, Italy
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Roma, 00168, Italy
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Bunkyō City, 113-8431, Japan
Research Site
Bunkyō City, 113-8677, Japan
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Kashiwa, 277-8577, Japan
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Kurume-shi, 830-0011, Japan
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Kyoto, 602-8566, Japan
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Niigata, 951-8566, Japan
Research Site
Shinjuku-ku, 162-8655, Japan
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Toyoake-shi, 470-1192, Japan
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Kuala Lumpur, 59100, Malaysia
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Kuala Selangor, 62250, Malaysia
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Kuching, 93586, Malaysia
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Singapore, 329563, Malaysia
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Chisinau, MD-2025, Moldova
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Amsterdam, 1066CX, Netherlands
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Groningen, 9713 GZ, Netherlands
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Leiden, 2333 ZA, Netherlands
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Lima, 15036, Peru
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Koszalin, 75-581, Poland
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Lodz, 93-338, Poland
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Olsztyn, 10-357, Poland
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Belgrade, 11000, Serbia
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Kragujevac, 34000, Serbia
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Niš, 18000, Serbia
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Seongbuk-Gu, 2841, South Korea
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Seoul, 03080, South Korea
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Seoul, 05505, South Korea
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Seoul, 3722, South Korea
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Seoul, 6351, South Korea
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Barcelona, 08035, Spain
Research Site
Barcelona, 08036, Spain
Research Site
L'Hospitalet de Llobregat, 08908, Spain
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Madrid, 28034, Spain
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Madrid, 28041, Spain
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Pamplona, 31008, Spain
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Pozuelo de Alarcón, 28223, Spain
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Valencia, 46009, Spain
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Valencia, 46010, Spain
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Taichung, 40201, Taiwan
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Taipei, 110, Taiwan
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Taipei, 11696, Taiwan
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Bangkok, 10700, Thailand
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Chanthaburi, 22000, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Rachathewi, 10400, Thailand
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Ankara, 06230, Turkey (Türkiye)
Research Site
Ankara, 6200, Turkey (Türkiye)
Research Site
Fatih, 34093, Turkey (Türkiye)
Research Site
Istanbul, 34752, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2025
First Posted
May 30, 2025
Study Start
November 24, 2025
Primary Completion (Estimated)
February 23, 2029
Study Completion (Estimated)
February 23, 2029
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.