Advanced or Metastatic Non-small Cell Lung CancerPhase 1/2ALTAIRNCT06996782

A Platform Study in Non-Small Cell Lung Cancer (NSCLC)

A Phase 1/2 study testing Rilvegostomig, Cisplatin and Carboplatin in people with Advanced or Metastatic Non-small Cell Lung Cancer, run by AstraZeneca at 103 sites in 20 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced or Metastatic Non-small Cell Lung Cancer
What is being tested?: Rilvegostomig, Cisplatin and Carboplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 152 participants
Where: 103 sitesin 20 countries
Study dates: 24 Nov 2025to 23 Feb 2029
Phase: Phase 1/2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.
Evidence of Grade ≥ 1 central nervous system (CNS) haemorrhage.
Uncontrolled arterial hypertension ≥ 150 mm Hg (systolic) and/or ≥ 100 mm Hg (diastolic).
Has radiologically documented evidence of major blood vessel invasion or encasement by cancer, or major airway invasion by cancer or intra-tumour cavitation.
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.
Has cirrhosis at a level of Child-Pugh B (or worse), or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
Prior systemic therapy received for advanced or mNSCLC.
Prior exposure to an anti-T-cell immunoreceptor with Ig and Immunoreceptor Tyrosine-based Inhibition Motif domains (TIGIT) therapy or immune-oncology agent such as anti-programmed cell death protein 1 (PD-1), anti-PD-L1, or anti-cytotoxic T-lymphocyte associated antigen 4 (CTLA-4), or any other anti-cancer therapy targeting immune-regulatory receptors or mechanisms.
Chronic therapy with antiplatelet agents.
Prior exposure to anti-vascular endothelial growth factor (VEGF) therapy.
Medical contraindication to protocol-specified platinum doublet regimens or ramucirumab.
Known allergy or hypersensitivity to rilvegostomig or any of the excipients of rilvegostomig, cisplatin, carboplatin, paclitaxel or nab-paclitaxel or pemetrexed or ramucirumab.

Trial locations and contacts

103 sites in 20 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

103 sites in 20 countries

China12 sites, 12 recruiting

Research Site
Chengdu, 610041
Not yet recruiting
Research Site
Chongqing, 400072
Recruiting
Research Site
Deyang, 618000
Recruiting
Research Site
Fuzhou, 350014
Not yet recruiting
Research Site
Guangzhou, 510405
Recruiting
Research Site
Jinan, 250013
Recruiting
Research Site
Shanghai, 200433
Recruiting
Research Site
Shanghai, 201114
Recruiting
Research Site
Shenyang, 110015
Not yet recruiting
Research Site
Shenzhen, 518116
Not yet recruiting
Research Site
Wuhan, 430022
Recruiting
Research Site
Wuhan, 430060
Recruiting

Other trials in China

United States10 sites, 9 recruiting

Research Site
Baltimore, Maryland, 21201
Recruiting
Research Site
Cleveland, Ohio, 44106
Recruiting
Research Site
Detroit, Michigan, 48202
Not yet recruiting
Research Site
Jacksonville, Florida, 32224
Recruiting
Research Site
Phoenix, Arizona, 85054
Recruiting
Research Site
Providence, Rhode Island, 02903
Recruiting
Research Site
Providence, Rhode Island, 02906
Withdrawn
Research Site
Rochester, Minnesota, 55905
Recruiting
Research Site
Santa Rosa, California, 95403
Recruiting
Research Site
Tyler, Texas, 75708
Recruiting

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Spain9 sites, 9 recruiting

Research Site
Barcelona, 08035
Not yet recruiting
Research Site
Barcelona, 08036
Not yet recruiting
Research Site
L'Hospitalet de Llobregat, 08908
Not yet recruiting
Research Site
Madrid, 28034
Not yet recruiting
Research Site
Madrid, 28041
Not yet recruiting
Research Site
Pamplona, 31008
Not yet recruiting
Research Site
Pozuelo de Alarcón, 28223
Recruiting
Research Site
Valencia, 46009
Not yet recruiting
Research Site
Valencia, 46010
Not yet recruiting

Other trials in Spain

Japan8 sites, 8 recruiting

Research Site
Bunkyō City, 113-8431
Recruiting
Research Site
Bunkyō City, 113-8677
Recruiting
Research Site
Kashiwa, 277-8577
Recruiting
Research Site
Kurume-shi, 830-0011
Recruiting
Research Site
Kyoto, 602-8566
Recruiting
Research Site
Niigata, 951-8566
Recruiting
Research Site
Shinjuku-ku, 162-8655
Recruiting
Research Site
Toyoake-shi, 470-1192
Recruiting

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Brazil7 sites, 7 recruiting

Research Site
Barretos, 14784-400
Recruiting
Research Site
Fortaleza, 60336-232
Recruiting
Research Site
Natal, 59075-740
Recruiting
Research Site
Pelotas, 096015-280
Recruiting
Research Site
Porto Alegre, 90035-903
Recruiting
Research Site
São Paulo, 01246-000
Recruiting
Research Site
São Paulo, 05651-901
Recruiting

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France7 sites, 7 recruiting

Research Site
Bordeaux, 33076
Recruiting
Research Site
Dijon, 21079
Not yet recruiting
Research Site
Limoges, 87000
Not yet recruiting
Research Site
Marseille, 13015
Not yet recruiting
Research Site
Nantes, 44093
Not yet recruiting
Research Site
Nice, 06189
Not yet recruiting
Research Site
Paris, 75005
Not yet recruiting

Other trials in France

Georgia5 sites, 4 recruiting

Research Site
Batumi, 6010
Recruiting
Research Site
Tbilisi, 0112
Recruiting
Research Site
Tbilisi, 0114
Recruiting
Research Site
Tbilisi, 0144
Recruiting
Research Site
Tbilisi, 0186
Withdrawn

Other trials in Georgia

Germany5 sites, 3 recruiting

Research Site
München, 81675
Not yet recruiting
Research Site
Münster, 48149
Withdrawn
Research Site
Oldenburg, 26121
Withdrawn
Research Site
Regensburg, 93053
Not yet recruiting
Research Site
Würzburg, 97080
Not yet recruiting

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Italy5 sites, 5 recruiting

Research Site
Milan, 20141
Not yet recruiting
Research Site
Milan, 20162
Not yet recruiting
Research Site
Orbassano, 10043
Not yet recruiting
Research Site
Pavia, 27100
Not yet recruiting
Research Site
Roma, 00168
Not yet recruiting

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South Korea5 sites, 5 recruiting

Research Site
Seongbuk-Gu, 2841
Recruiting
Research Site
Seoul, 03080
Recruiting
Research Site
Seoul, 05505
Recruiting
Research Site
Seoul, 3722
Recruiting
Research Site
Seoul, 6351
Recruiting

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Thailand5 sites, 5 recruiting

Research Site
Bangkok, 10700
Recruiting
Research Site
Chanthaburi, 22000
Recruiting
Research Site
Hat Yai, 90110
Recruiting
Research Site
Khon Kaen, 40002
Recruiting
Research Site
Rachathewi, 10400
Recruiting

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Malaysia4 sites, 4 recruiting

Research Site
Kuala Lumpur, 59100
Recruiting
Research Site
Kuala Selangor, 62250
Recruiting
Research Site
Kuching, 93586
Recruiting
Research Site
Singapore, 329563
Recruiting

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Turkey (Türkiye)4 sites, 3 recruiting

Research Site
Ankara, 06230
Recruiting
Research Site
Ankara, 6200
Recruiting
Research Site
Fatih, 34093
Not yet recruiting
Research Site
Istanbul, 34752
Withdrawn

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Belgium3 sites, 3 recruiting

Research Site
Anderlecht, 1070
Not yet recruiting
Research Site
Hasselt, 3500
Not yet recruiting
Research Site
Leuven, 3000
Not yet recruiting

Other trials in Belgium

Netherlands3 sites, 3 recruiting

Research Site
Amsterdam, 1066CX
Not yet recruiting
Research Site
Groningen, 9713 GZ
Not yet recruiting
Research Site
Leiden, 2333 ZA
Not yet recruiting

Other trials in Netherlands

Poland3 sites, 3 recruiting

Research Site
Koszalin, 75-581
Not yet recruiting
Research Site
Lodz, 93-338
Not yet recruiting
Research Site
Olsztyn, 10-357
Not yet recruiting

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Serbia3 sites

Research Site
Belgrade, 11000
Withdrawn
Research Site
Kragujevac, 34000
Withdrawn
Research Site
Niš, 18000
Withdrawn

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Taiwan3 sites, 3 recruiting

Research Site
Taichung, 40201
Recruiting
Research Site
Taipei, 110
Recruiting
Research Site
Taipei, 11696
Recruiting

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Moldova1 site, 1 recruiting

Research Site
Chisinau, MD-2025
Recruiting

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Peru1 site

Research Site
Lima, 15036
Withdrawn

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About this study

Official title: A Phase Ib/II Open-Label, Multicentre Platform Study Evaluating Novel Combinations in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer

Read the detailed description

This is a multicentre, open-label study to evaluate the safety and efficacy of various combinations of study interventions in participants with advanced or metastatic NSCLC (mNSCLC).

The study will include a sub-study (sub-study 2) focused on a specific treatment that may include 2 parts -

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
Part B consisting of one or more expansion cohorts.

The originally planned Sub-study 1 was withdrawn (cancelled) and will not be conducted.

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: Advanced or Metastatic Non-small Cell Lung Cancer
Being tested: Rilvegostomig, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel
Keywords: Checkpoint inhibitor (CPI), Platinum-based chemotherapy, T-cell immunoreceptor with lg and Immunoreceptor Tyrosine-based Inhibition Motif (ITIM) domains (TIGIT), Programmed death-ligand 1 (PD-L1)
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RilvegostomigDrug
Also called AZD2936
Rilvegostomig will be administered as an intravenous (IV) infusion.
CisplatinDrug
Cisplatin will be administered as SoC as an IV infusion.
CarboplatinDrug
Carboplatin will be administered as SoC as an IV infusion.
PemetrexedDrug
Pemetrexed will be administered as SoC as an IV infusion.
PaclitaxelDrug
Paclitaxel will be administered as SoC as an IV infusion.
Nab-paclitaxelDrug
Nab-paclitaxel will be administered as SoC as an IV infusion.
RamucirumabDrug
Ramucirumab will be administered as an IV infusion.

Study groups in NCT06996782
Study group	Role	What they receive
Sub study 2 Part A: Safety run-in	Experimental	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. Receives: Drug: Rilvegostomig; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Ramucirumab
Sub study 2 Part B: Dose expansion	Experimental	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. Receives: Drug: Rilvegostomig; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Ramucirumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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).
Measured: Approximately 46 months

Secondary outcomes (18)

Part A: Objective response (OR)
The OR is defined as a BOR of confirmed CR or confirmed PR.
Measured: Approximately 46 months
Part A and Part B: Duration of response (DOR)
The DoR is defined as the time from the date of first documented objective response (which is subsequently confirmed) until date of first documented disease progression or death (by any cause in the absence of disease progression).
Measured: Approximately 46 months
Part A and Part B: Time to response (TTR)
Time to response is defined as the time from the start of treatment until the date of first documented response.
Measured: Approximately 46 months
Part A and Part B: Disease control (DC)
Disease control is defined as if a participant has a best overall response of confirmed CR or confirmed PR or who have stable disease (SD) for at least 7 weeks after start of treatment.
Measured: Approximately 46 months
Part A and Part B: Progression free survival (PFS)
Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from assigned therapy or receives another anti-cancer therapy prior to progression.
Measured: Approximately 46 months
Part A and Part B: Progression free survival at 6 months (PFS6)
Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from assigned therapy or receives another anti-cancer therapy prior to progression.
Measured: From Day 1 pre-dose to 6 months
Part A and Part B: Progression free survival at 12 months (PFS12)
Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from assigned therapy or receives another anti-cancer therapy prior to progression.
Measured: From Day 1 pre-dose to 12 months
Part A and Part B: Overall survival (OS)
Overall survival is defined as the time from the start of treatment until death due to any cause regardless of whether the participant withdraws from study therapy or receives another anti-cancer therapy.
Measured: Approximately 46 months
Part A and Part B: Overall survival at 12 months (OS12)
Overall survival is defined as the time from the start of treatment until death due to any cause regardless of whether the participant withdraws from study therapy or receives another anti-cancer therapy.
Measured: From Day 1 pre-dose to 12 months
Part A and Part B: Serum concentration
To assess the serum concentration of the novel anti-cancer agents in combination.
Measured: Approximately 46 months
Part A and Part B: Maximum plasma drug concentration (Cmax)
To assess the Cmax of the novel anti-cancer agents in combination.
Measured: Approximately 46 months
Part A and Part B: Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast)
To assess the AUClast of the novel anti-cancer agents in combination.
Measured: Approximately 46 months
Part A and Part B: Area under plasma concentration-time curve from time 0 to infinity (AUC∞)
To assess the AUC∞ of the novel anti-cancer agents in combination.
Measured: Approximately 46 months
Part A and Part B: Time to reach maximum concentration following drug administration (tmax)
To assess the tmax of the novel anti-cancer agents in combination.
Measured: Approximately 46 months
Part A and Part B: Terminal elimination half-life (t1/2λz)
To assess the t1/2λz of the novel anti-cancer agents in combination.
Measured: Approximately 46 months
Part A and Part B: Clearance (CL)
To assess the CL of the novel anti-cancer agents in combination.
Measured: Approximately 46 months
Part A and Part B: Volume of distribution at terminal phase (Vz)
To assess the Vz of the novel anti-cancer agents in combination.
Measured: Approximately 46 months
Part A and Part B: Number of participants with anti-drug antibodies (ADAs)
To assess the immunogenicity of the novel anti-cancer agents in combination.
Measured: Approximately 46 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Nov 202523 Feb 2029

First posted30 May 2025
Study start24 Nov 2025
Primary completion23 Feb 2029 (estimated)
Study completion23 Feb 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced or Metastatic Non-small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 152 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06996782
Sponsor's protocol ID: D702KC00001
Other IDs: 2024-519786-22
Acronym: ALTAIR
Status last verified: Oct 2026
First submitted: 5 May 2025
Last updated: 28 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib/II Open-Label, Multicentre Platform Study Evaluating Novel Combinations in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06996782
Acronym / sponsor ID: ALTAIR / D702KC00001
Conditions: Advanced or Metastatic Non-small Cell Lung Cancer
Keywords: Checkpoint inhibitor (CPI), Platinum-based chemotherapy, T-cell immunoreceptor with lg and Immunoreceptor Tyrosine-based Inhibition Motif (ITIM) domains (TIGIT), Programmed death-ligand 1 (PD-L1)
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 152 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 24 Nov 2025 (actual)
Primary completion: 23 Feb 2029 (estimated)
Study completion: 23 Feb 2029 (estimated)
First posted: 30 May 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is a multicentre, open-label study to evaluate the safety and efficacy of various combinations of study interventions in participants with advanced or metastatic NSCLC (mNSCLC).

The study will include a sub-study (sub-study 2) focused on a specific treatment that may include 2 parts -

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
Part B consisting of one or more expansion cohorts.

The originally planned Sub-study 1 was withdrawn (cancelled) and will not be conducted.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sub study 2 Part A: Safety run-in	Experimental	Drug: Rilvegostomig, Drug: Cisplatin, Drug: Carboplatin, Drug: Pemetrexed, Drug: Paclitaxel, Drug: Nab-paclitaxel, Drug: RamucirumabParticipants 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	Experimental	Drug: Rilvegostomig, Drug: Cisplatin, Drug: Carboplatin, Drug: Pemetrexed, Drug: Paclitaxel, Drug: Nab-paclitaxel, Drug: RamucirumabParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (28 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RilvegostomigAlso: AZD2936Rilvegostomig will be administered as an intravenous (IV) infusion.	Drug	Sub study 2 Part A: Safety run-in, Sub study 2 Part B: Dose expansion
CisplatinCisplatin will be administered as SoC as an IV infusion.	Drug	Sub study 2 Part A: Safety run-in, Sub study 2 Part B: Dose expansion
CarboplatinCarboplatin will be administered as SoC as an IV infusion.	Drug	Sub study 2 Part A: Safety run-in, Sub study 2 Part B: Dose expansion
PemetrexedPemetrexed will be administered as SoC as an IV infusion.	Drug	Sub study 2 Part A: Safety run-in, Sub study 2 Part B: Dose expansion
PaclitaxelPaclitaxel will be administered as SoC as an IV infusion.	Drug	Sub study 2 Part A: Safety run-in, Sub study 2 Part B: Dose expansion
Nab-paclitaxelNab-paclitaxel will be administered as SoC as an IV infusion.	Drug	Sub study 2 Part A: Safety run-in, Sub study 2 Part B: Dose expansion
RamucirumabRamucirumab will be administered as an IV infusion.	Drug	Sub study 2 Part A: Safety run-in, Sub study 2 Part B: Dose expansion

Primary outcome

Part A and Part B: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Approximately 46 months
To assess the safety and tolerability and determine RP2D of the combination of novel anti-cancer agents.
Part A: Number of partcipants with dose limiting toxicity (DLT)
Time frame: Approximately 46 months
To assess the safety and tolerability and determine RP2D of the combination of novel anti-cancer agents.
Part B: Objective response (OR)
Time frame: Approximately 46 months
The OR is defined as a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR).

18 secondary outcomes

Part A: Objective response (OR)
Time frame: Approximately 46 months
Part A and Part B: Duration of response (DOR)
Time frame: Approximately 46 months
Part A and Part B: Time to response (TTR)
Time frame: Approximately 46 months
Part A and Part B: Disease control (DC)
Time frame: Approximately 46 months
Part A and Part B: Progression free survival (PFS)
Time frame: Approximately 46 months
Part A and Part B: Progression free survival at 6 months (PFS6)
Time frame: From Day 1 pre-dose to 6 months
Part A and Part B: Progression free survival at 12 months (PFS12)
Time frame: From Day 1 pre-dose to 12 months
Part A and Part B: Overall survival (OS)
Time frame: Approximately 46 months
Part A and Part B: Overall survival at 12 months (OS12)
Time frame: From Day 1 pre-dose to 12 months
Part A and Part B: Serum concentration
Time frame: Approximately 46 months
Part A and Part B: Maximum plasma drug concentration (Cmax)
Time frame: Approximately 46 months
Part A and Part B: Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast)
Time frame: Approximately 46 months
Part A and Part B: Area under plasma concentration-time curve from time 0 to infinity (AUC∞)
Time frame: Approximately 46 months
Part A and Part B: Time to reach maximum concentration following drug administration (tmax)
Time frame: Approximately 46 months
Part A and Part B: Terminal elimination half-life (t1/2λz)
Time frame: Approximately 46 months
Part A and Part B: Clearance (CL)
Time frame: Approximately 46 months
Part A and Part B: Volume of distribution at terminal phase (Vz)
Time frame: Approximately 46 months
Part A and Part B: Number of participants with anti-drug antibodies (ADAs)
Time frame: Approximately 46 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

103 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Rilvegostomig, Cisplatin and Carboplatin in people with Advanced or Metastatic Non-small Cell Lung Cancer, run by AstraZeneca at 103 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in China, United States, Spain, Japan, Brazil and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A and Part B: Number of participants with adverse events (AEs) and serious adverse events (SAEs) (time frame: Approximately 46 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06996782.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.