Non-Small Cell Lung CancerPhase 2LIBRANCT07098338

A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 study testing Rilvegostomig, Ramucirumab and Dato-DXd in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 83 sites in 12 countries.

Recruiting

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

Sites and contacts

Official record

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Trial summary

This is a Phase II, multi-center, open-label platform study evaluating novel combination treatment options in participants with locally advanced or metastatic NSCLC. The study will consist of several sub-studies, each evaluating the safety, tolerability, and preliminary antitumour activity of various treatment… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: Rilvegostomig, Ramucirumab and Dato-DXd
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 278 participants
Where: 83 sitesin 12 countries
Study dates: 7 Aug 2025to 6 Apr 2029
Phase: Phase 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

Participant must be ≥ 18 years of age at the time of signing the ICF
WHO/ECOG performance status of 0 or 1
At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.
Adequate bone marrow and organ function
Life expectancy ≥ 12 weeks
Provision of acceptable tumour tissue

Show all 13Show fewer

Specific Inclusion Criteria for Sub-Study 1 and Sub-Study 2:
Histologically or cytologically documented advanced or metastatic NSCLC
PD-L1 TC ≥ 1% (TC≥ 50% for sub-study 1, 1-49% for sub-study 2)
Absence of sensitizing EGFR mutations or ALK rearrangements. No known other Actionable Genomic Alterations(AGAs)
Specific Inclusion Criteria for Sub-Study 3:
Histologically or cytologically documented advanced or metastatic non-squamous NSCLC
Documented positive AGA and had progressed on prior targeted therapy

Who cannot join

As judged by the investigator, any severe or uncontrolled systemic diseases, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol
Active or prior documented autoimmune or inflammatory disorders
Persistent toxicities (CTCAE Grade ≥ 2) (NCI CTCAE v5.0) caused by previous anti cancer therapy, excluding alopecia.
Spinal cord compression or leptomeningeal carcinomatosis for sub-study 1 and sub-study 2. Unstable spinal cord compression for sub-study 3
Unstable brain metastases
History of another primary malignancy.

Show all 13Show fewer

Active infection, including TB and infections with HIV, HBV (verified by known positive HBsAg result), HCV.
Uncontrolled or significant cardiac disease
Receipt of prior systemic chemotherapy/chemoradiation/immunotherapy for advanced NSCLC for sub-study 1 and sub-study 2.
Prior exposure to immune-mediated therapy
History of uncontrolled hypertension, and active bleeding diseases, and high risks of bleeding and disorders of coagulation
Any concurrent anti-cancer treatment.
Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention.

Trial locations and contacts

83 sites in 12 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

83 sites in 12 countries

China19 sites, 18 recruiting

Research Site
Changsha, 410013
Recruiting
Research Site
Chengdu, 610041
Recruiting
Research Site
Deyang, 618000
Recruiting
Research Site
Dongguan, 523059
Recruiting
Research Site
Fuzhou, 350014
Withdrawn
Research Site
Guangzhou, 510080
Recruiting
Research Site
Guangzhou, 510100
Recruiting
Research Site
Hangzhou, 310014
Recruiting
Research Site
Hefei, 230022
Recruiting
Research Site
Linyi, 276001
Recruiting
Research Site
Mianyang, 621000
Recruiting
Research Site
Nanchang, 330000
Recruiting
Research Site
Nanchang, 330006
Recruiting
Research Site
Shantou
Recruiting
Research Site
Shenyang, 110042
Recruiting
Research Site
Wuhan, 430022
Recruiting
Research Site
Zhengzhou, 450000
Recruiting
Research Site
Zhengzhou, 450008
Recruiting
Research Site
Zhuhai, 519000
Recruiting

Other trials in China

Japan11 sites, 11 recruiting

Research Site
Bunkyō City, 113-8677
Recruiting
Research Site
Fukuyama-shi, 722-0001
Recruiting
Research Site
Kobe, 650-0047
Recruiting
Research Site
Kurume-shi, 830-0011
Recruiting
Research Site
Kyoto, 602-8566
Recruiting
Research Site
Kyoto, 606-8507
Recruiting
Research Site
Osaka, 541-8567
Recruiting
Research Site
Sakaishi, 591-8555
Recruiting
Research Site
Shinjuku-ku, 162-8655
Recruiting
Research Site
Wakayama, 641-8510
Recruiting
Research Site
Yokohama, 236-0051
Recruiting

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South Korea9 sites, 9 recruiting

Research Site
Cheongju-si, 28644
Recruiting
Research Site
Namdong-gu, 21565
Recruiting
Research Site
Seongnam-si, 13496
Recruiting
Research Site
Seoul, 03080
Recruiting
Research Site
Seoul, 06351
Recruiting
Research Site
Seoul, 3722
Recruiting
Research Site
Seoul, 5505
Recruiting
Research Site
Suwon, 16247
Recruiting
Research Site
Suwon, 16499
Recruiting

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Taiwan9 sites, 9 recruiting

Research Site
Liuying, 736
Recruiting
Research Site
Taichung, 402
Recruiting
Research Site
Taichung, 40447
Recruiting
Research Site
Tainan, 70403
Recruiting
Research Site
Tainan, 710
Recruiting
Research Site
Taipei, 100
Recruiting
Research Site
Taipei, 110
Recruiting
Research Site
Taipei, 11217
Recruiting
Research Site
Taoyuan, 00333
Recruiting

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Italy8 sites, 8 recruiting

Research Site
Aviano, 33081
Not yet recruiting
Research Site
Catania, 95123
Not yet recruiting
Research Site
Meldola, 47014
Not yet recruiting
Research Site
Milan, 20141
Not yet recruiting
Research Site
Milan, 35128
Not yet recruiting
Research Site
Orbassano, 10043
Not yet recruiting
Research Site
Roma, 00144
Not yet recruiting
Research Site
Rozzano, 20089
Not yet recruiting

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United States6 sites, 6 recruiting

Research Site
Atlanta, Georgia, 30318
Recruiting
Research Site
Baltimore, Maryland, 21231
Not yet recruiting
Research Site
Fairfax, Virginia, 22031
Recruiting
Research Site
Houston, Texas, 77090
Not yet recruiting
Research Site
Santa Monica, California, 90404
Recruiting
Research Site
Santa Rosa, California, 95403
Not yet recruiting

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Spain6 sites, 6 recruiting

Research Site
A Coruña, 15006
Not yet recruiting
Research Site
Madrid, 28041
Not yet recruiting
Research Site
Málaga, 29009
Recruiting
Research Site
Manresa, 08243
Recruiting
Research Site
Santander, 39008
Recruiting
Research Site
Valencia, 46010
Not yet recruiting

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France5 sites, 5 recruiting

Research Site
Avignon, 84902
Not yet recruiting
Research Site
Paris, 75005
Not yet recruiting
Research Site
Rennes, 35000
Not yet recruiting
Research Site
Saint-Herblain, 44805
Not yet recruiting
Research Site
Suresnes, 92150
Recruiting

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Thailand4 sites, 4 recruiting

Research Site
Bangkok, 10330
Recruiting
Research Site
Bangkok, 10400
Not yet recruiting
Research Site
Bangkok, 10700
Not yet recruiting
Research Site
Banphaeo, 74120
Recruiting

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Australia3 sites, 3 recruiting

Research Site
Heidelberg, 3084
Not yet recruiting
Research Site
Nedlands, 6009
Not yet recruiting
Research Site
Woodville, 5011
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Singapore2 sites, 2 recruiting

Research Site
Singapore, 119082
Recruiting
Research Site
Singapore, 168583
Recruiting

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Canada1 site, 1 recruiting

Research Site
Toronto, Ontario, M5G 2M9
Not yet recruiting

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About this study

Official title: An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)

Read the detailed description

The master protocol will include 3 sub-studies, each focused on a specific disease population.

Sub-study 1 will investigate rilvegostomig± ramucirumab in 1L non-actionable genomic alterations (AGA) NSCLC with PD-L1 ≥50%.
Sub-study 2 will investigate rilvegostomig + ramucirumab in 1L non-actionable genomic alterations (AGA) NSCLC with PD-L1 1-49%.
Sub-study 3 will investigate Dato-DXd + ramucirumab ± rilvegostomig in 2/3L AGA+

Each sub-study may include 2 parts (unless stated in the individual sub study protocols): Part A: one or more Safety Run-in cohort(s), and Part B: one or more Dose Expansion cohort(s).

Conditions: Non-Small Cell Lung Cancer
Being tested: Rilvegostomig, Ramucirumab, Dato-DXd
Keywords: Non-Small Cell Lung Cancer(NSCLC), Antibody-Drug Conjugates (ADCs), T-cell immunoreceptor with Ig 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 IV infusion.
RamucirumabDrug
Also called Cyramza
Ramucirumab will be administered as IV infusion.
Dato-DXdDrug
Also called DS-1062
Dato-DXd will be administered as IV infusion.

Study groups in NCT07098338
Study group	Role	What they receive
Sub-study 1, investigate rilvegostomig± ramucirumab in 1L non-AGA NSCLC with PD-L1 ≥50%	Experimental	Participants will receive rilvegostomig ± ramucirumab until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion Receives: Drug: Rilvegostomig; Drug: Ramucirumab
Sub-study 2, investigate rilvegostomig + ramucirumab in 1L non-AGA NSCLC with PD-L1 1-49%	Experimental	Participants will receive rilvegostomig + ramucirumab until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion Receives: Drug: Rilvegostomig; Drug: Ramucirumab
Sub-study 3, investigate Dato-DXd + ramucirumab ± rilvegostomig in 2/3L AGA+ NSCLC	Experimental	Participants will receive Dato-DXd + ramucirumab ± rilvegostomig until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion Receives: Drug: Rilvegostomig; Drug: Ramucirumab; Drug: Dato-DXd

What is being measured

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

Number of participants with adverse events (AE) and serious adverse events (SAE)
To assess the safety and tolerability
Measured: Through study completion, an average of 3 years
Objective response rate (ORR)
ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response) per RECIST 1.1
Measured: Through study completion, an average of 3 years

Secondary outcomes (9)

Best Overall Response(BOR)
BOR is the best response a participant has had following randomisation/start of dosing, but prior to starting any subsequent cancer therapy and up to and including RECIST progression or the last evaluable assessment in the absence of RECIST progression
Measured: Through study completion, an average of 3 years
Change in Target Lesion Tumor Size
The best percentage change from baseline in Target Lesion tumour size is the largest decrease (or smallest increase) from baseline for a participant, using RECIST 1.1 assessments
Measured: Through study completion, an average of 3 years
Progression free survival (PFS)
PFS 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) per RECIST 1.1.
Measured: Through study completion, an average of 3 years
Disease Control Rate(DCR) at 12 Weeks
DCR at 12 weeks is defined as the percentage of participants who have a best objective response of confirmed CR or PR or who have SD for at least 11 weeks after start of treatment (to allow for an early assessment within the assessment window).
Measured: From Day 1 pre-dose to 12 weeks
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: Through study completion, an average of 3 years
Overall Survival(OS)
OS is defined as the time from the start of treatment until death due to any cause.
Measured: Through study completion, an average of 3 years
Serum concentration
To assess the serum concentration of the novel anti-cancer agents in combination.
Measured: Through study completion, an average of 3 years
Maximum plasma drug concentration (Cmax)
To assess the Cmax of the novel anti-cancer agents in combination.
Measured: Through study completion, an average of 3 years
Immunogenicity of study interventions in participants receiving treatment
Presence of Anti Drug Antibodies（ADAs) for study interventions in serum/plasma
Measured: Through study completion, an average of 3 years

Timeline

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

7 Aug 20256 Apr 2029

First posted1 Aug 2025
Study start7 Aug 2025
Primary completion6 Apr 2029 (estimated)
Study completion6 Apr 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 278 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07098338
Sponsor's protocol ID: D6187C00001
Acronym: LIBRA
Status last verified: Oct 2026
First submitted: 4 Jul 2025
Last updated: 15 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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Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
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All Non-Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)
ClinicalTrials.gov ID: NCT07098338
Acronym / sponsor ID: LIBRA / D6187C00001
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer(NSCLC), Antibody-Drug Conjugates (ADCs), T-cell immunoreceptor with Ig and Immunoreceptor Tyrosine-based Inhibition Motif (ITIM) domains (TIGIT), Programmed death-ligand 1 (PD-L1)
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 278 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Daiichi Sankyo
Study start: 7 Aug 2025 (actual)
Primary completion: 6 Apr 2029 (estimated)
Study completion: 6 Apr 2029 (estimated)
First posted: 1 Aug 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

The master protocol will include 3 sub-studies, each focused on a specific disease population.

Sub-study 1 will investigate rilvegostomig± ramucirumab in 1L non-actionable genomic alterations (AGA) NSCLC with PD-L1 ≥50%.
Sub-study 2 will investigate rilvegostomig + ramucirumab in 1L non-actionable genomic alterations (AGA) NSCLC with PD-L1 1-49%.
Sub-study 3 will investigate Dato-DXd + ramucirumab ± rilvegostomig in 2/3L AGA+

Each sub-study may include 2 parts (unless stated in the individual sub study protocols): Part A: one or more Safety Run-in cohort(s), and Part B: one or more Dose Expansion cohort(s).

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Sub-study 1, investigate rilvegostomig± ramucirumab in 1L non-AGA NSCLC with PD-L1 ≥50%	Experimental	Drug: Rilvegostomig, Drug: RamucirumabParticipants will receive rilvegostomig ± ramucirumab until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion
Sub-study 2, investigate rilvegostomig + ramucirumab in 1L non-AGA NSCLC with PD-L1 1-49%	Experimental	Drug: Rilvegostomig, Drug: RamucirumabParticipants will receive rilvegostomig + ramucirumab until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion
Sub-study 3, investigate Dato-DXd + ramucirumab ± rilvegostomig in 2/3L AGA+ NSCLC	Experimental	Drug: Rilvegostomig, Drug: Ramucirumab, Drug: Dato-DXdParticipants will receive Dato-DXd + ramucirumab ± rilvegostomig until RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criterion

Who may qualify

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

Key inclusion criteria (13 listed)

Participant must be ≥ 18 years of age at the time of signing the ICF
WHO/ECOG performance status of 0 or 1
At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.
Adequate bone marrow and organ function
Life expectancy ≥ 12 weeks

Key exclusion criteria (13 listed)

As judged by the investigator, any severe or uncontrolled systemic diseases, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol
Active or prior documented autoimmune or inflammatory disorders
Persistent toxicities (CTCAE Grade ≥ 2) (NCI CTCAE v5.0) caused by previous anti cancer therapy, excluding alopecia.
Spinal cord compression or leptomeningeal carcinomatosis for sub-study 1 and sub-study 2. Unstable spinal cord compression for sub-study 3
Unstable brain metastases

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 IV infusion.	Drug	Sub-study 1, investigate rilvegostomig± ramucirumab in 1L non-AGA NSCLC with PD-L1 ≥50%, Sub-study 2, investigate rilvegostomig + ramucirumab in 1L non-AGA NSCLC with PD-L1 1-49%, Sub-study 3, investigate Dato-DXd + ramucirumab ± rilvegostomig in 2/3L AGA+ NSCLC
RamucirumabAlso: CyramzaRamucirumab will be administered as IV infusion.	Drug	Sub-study 1, investigate rilvegostomig± ramucirumab in 1L non-AGA NSCLC with PD-L1 ≥50%, Sub-study 2, investigate rilvegostomig + ramucirumab in 1L non-AGA NSCLC with PD-L1 1-49%, Sub-study 3, investigate Dato-DXd + ramucirumab ± rilvegostomig in 2/3L AGA+ NSCLC
Dato-DXdAlso: DS-1062Dato-DXd will be administered as IV infusion.	Drug	Sub-study 3, investigate Dato-DXd + ramucirumab ± rilvegostomig in 2/3L AGA+ NSCLC

Primary outcome

Number of participants with adverse events (AE) and serious adverse events (SAE)
Time frame: Through study completion, an average of 3 years
To assess the safety and tolerability
Objective response rate (ORR)
Time frame: Through study completion, an average of 3 years
ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response) per RECIST 1.1

9 secondary outcomes

Best Overall Response(BOR)
Time frame: Through study completion, an average of 3 years
Change in Target Lesion Tumor Size
Time frame: Through study completion, an average of 3 years
Progression free survival (PFS)
Time frame: Through study completion, an average of 3 years
Disease Control Rate(DCR) at 12 Weeks
Time frame: From Day 1 pre-dose to 12 weeks
Duration Of Response (DoR)
Time frame: Through study completion, an average of 3 years
Overall Survival(OS)
Time frame: Through study completion, an average of 3 years
Serum concentration
Time frame: Through study completion, an average of 3 years
Maximum plasma drug concentration (Cmax)
Time frame: Through study completion, an average of 3 years
Immunogenicity of study interventions in participants receiving treatment
Time frame: Through study completion, an average of 3 years

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 15 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

83 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rilvegostomig, Ramucirumab and Dato-DXd in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 83 sites in 12 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 13 inclusion and 13 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 15 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 83 sites in China, Japan, South Korea, Taiwan, Italy and 7 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 phase mean?

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?

Number of participants with adverse events (AE) and serious adverse events (SAE) (time frame: Through study completion, an average of 3 years). The study lists 2 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 NCT07098338.

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 15 Oct 2026.