Large B-cell LymphomaPhase 3Soundtrack D3NCT07911553
A Study to Evaluate Surovatamig Combined With R-CHOP in Participants of 18 to < 80 Years of Age With Previously Untreated Large B-cell Lymphoma With IPI Score 2 to 5
A Phase 3 study testing Surovatamig, Rituximab and Cyclophosphamide in people with Large B-cell Lymphoma, run by AstraZeneca.
Trial summary
This is a study to evaluate the efficacy of surovatamig combined with rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) in participants aged 18 to < 80 years of age with previously untreated large B-cell lymphoma (LBCL) with International Prognostic Index (IPI) score 2 to 5. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Large B-cell Lymphoma
- What is being tested?
- Surovatamig, Rituximab and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 22 Dec 2026to 1 Sep 2032
- Phase
- Phase 3
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed previously untreated large B-cell lymphoma.
- IPI score of 2 to 5.
- Measurable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Adequate organ function.
- Availability of tumour tissue.
- Meets protocol-defined contraception and pregnancy requirements.
Who cannot join
- Prior systemic treatment for large B-cell lymphoma.
- Primary or secondary central nervous system lymphoma.
- Active uncontrolled infection.
- Significant uncontrolled medical condition that may interfere with study participation.
- Active autoimmune disease requiring systemic treatment.
- History of clinically significant interstitial lung disease or pneumonitis.
- Pregnancy or breastfeeding.
- Known hypersensitivity to study treatment components.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
About this study
Official title: A Phase III Study to Evaluate the Efficacy of Surovatamig Combined With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Previously Untreated Large B-cell Lymphoma (Soundtrack D3)
This is a study to evaluate the efficacy of surovatamig combined with rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) in participants aged 18 to < 80 years of age with previously untreated large B-cell lymphoma (LBCL) with International Prognostic Index (IPI) score 2 to 5.
Read the detailed description
This is an open-label, multicentre, randomised controlled study.
The study will have the following sequential periods:
- Screening period
- Treatment period
- Follow-up period
The study has 2 arms:
- the experimental arm comprises of surovatamig plus R-CHOP
- the control arm comprises of either R-CHOP or rituximab, cyclophosphamide, doxorubicin, prednisone (or equivalent) and polatuzumab vedotin (Pola-R-CHP)
- Conditions
- Large B-cell Lymphoma
- Being tested
- Surovatamig, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
- Keywords
- IgG4 fully human CD19xCD3 bispecific T-cell engager, B-cell lymphoma, Polatuzumab vedotin, Prednisone, Rituximab, Cyclophosphamide, Vincristine, Doxorubicin, Surovatamig
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurovatamigDrug
Also called AZD0486
Fully human bispecific monoclonal immunoglobulins (Ig) G4 antibody
RituximabDrug
Rituximab will be administered to participants as per SoC.
CyclophosphamideDrug
Cyclophosphamide will be administered to participants as per SoC.
DoxorubicinDrug
Doxorubicin will be administered to participants as per SoC.
VincristineDrug
Vincristine will be administered to participants as per SoC.
PrednisoneDrug
Prednisone (or equivalent) will be administered to participants as per SoC.
Polatuzumab vedotinDrug
Polatuzumab vedotin will be administered to participants as per SoC.
| Study group | Role | What they receive |
|---|---|---|
| Surovatamig and R-CHOP | Experimental | Participants will receive surovatamig in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy according to standard of care (SoC). Receives: Drug: Surovatamig; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone |
| R-CHOP or Pola-R-CHP | Active comparator | Participants will receive either R-CHOP or Pola-R-CHP (rituximab, cyclophosphamide, doxorubicin, prednisone [or equivalent]) and polatuzumab vedotin) according to SoC. Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Polatuzumab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) as assessed by Blinded Independent Central Review (BICR)
The PFS is defined as the time from randomisation to the first occurrence of disease progression as determined by an Independent Review Committee (IRC), or death from any cause, whichever occurs first.
Measured: Up to 10 years
Secondary outcomes (8)
Overall survival (OS)
The OS is defined as the time from randomisation to death due to any cause.
Measured: Up to 10 years
PFS as assessed by the investigator
The PFS is defined as the time from randomisation to the first occurrence of disease progression as determined by the investigator, or death from any cause.
Measured: Up to 10 years
Event-free survival efficacy (EFSeff)
The EFSeff is defined as the time from randomisation to the first occurrence of disease progression, relapse, death from any cause, initiation of new antilymphoma treatment for an efficacy-related reason.
Measured: Up to 10 years
Overall response (OR) rate
The OR is defined as the percentage of participants who achieve a partial response (PR) or complete response (CR), as assessed by the investigator and IRC separately.
Measured: Up to 10 years
CR rate
The CR is defined as the percentage of participants who achieve a CR, as assessed by the investigator and IRC separately.
Measured: Up to 10 years
Duration of response (DoR)
The DoR is defined as the time from the first documented OR to disease progression or death from any cause, whichever occurs first, as assessed by IRC.
Measured: Up to 10 years
Duration of Complete Response (DOCR)
The DOCR is defined as the time from the first occurrence of a documented CR to disease progression, or death, whichever occurs first, as assessed by IRC.
Measured: Up to 10 years
Disease-free survival (DFS)
The DFS is defined as the time from a documented CR at the end of treatment to disease progression or death from any cause, whichever occurs first, as assessed by the investigator and IRC separately.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start22 Dec 2026 (estimated)
- Primary completion2 Sep 2030 (estimated)
- Study completion1 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large B-cell LymphomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911553
- Sponsor's protocol ID
- D7403C00001
- Other IDs
- 2026-526169-71-00
- Acronym
- Soundtrack D3
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study to Evaluate the Efficacy of Surovatamig Combined With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Previously Untreated Large B-cell Lymphoma (Soundtrack D3)
- ClinicalTrials.gov ID
- NCT07911553
- Acronym / sponsor ID
- Soundtrack D3 / D7403C00001
- Conditions
- Large B-cell Lymphoma
- Keywords
- IgG4 fully human CD19xCD3 bispecific T-cell engager, B-cell lymphoma, Polatuzumab vedotin, Prednisone, Rituximab, Cyclophosphamide, Vincristine, Doxorubicin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 22 Dec 2026 (estimated)
- Primary completion
- 2 Sep 2030 (estimated)
- Study completion
- 1 Sep 2032 (estimated)
- First posted
- 2 Nov 2026 (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.
This is a study to evaluate the efficacy of surovatamig combined with rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) in participants aged 18 to < 80 years of age with previously untreated large B-cell lymphoma (LBCL) with International Prognostic Index (IPI) score 2 to 5.
Detailed description
This is an open-label, multicentre, randomised controlled study.
The study will have the following sequential periods:
- Screening period
- Treatment period
- Follow-up period
The study has 2 arms:
- the experimental arm comprises of surovatamig plus R-CHOP
- the control arm comprises of either R-CHOP or rituximab, cyclophosphamide, doxorubicin, prednisone (or equivalent) and polatuzumab vedotin (Pola-R-CHP)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surovatamig and R-CHOP | Experimental | Drug: Surovatamig, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: PrednisoneParticipants will receive surovatamig in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy according to standard of care (SoC). |
| R-CHOP or Pola-R-CHP | Active comparator | Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone, Drug: Polatuzumab vedotinParticipants will receive either R-CHOP or Pola-R-CHP (rituximab, cyclophosphamide, doxorubicin, prednisone [or equivalent]) and polatuzumab vedotin) according to SoC. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed previously untreated large B-cell lymphoma.
- IPI score of 2 to 5.
- Measurable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Adequate organ function.
Key exclusion criteria (8 listed)
- Prior systemic treatment for large B-cell lymphoma.
- Primary or secondary central nervous system lymphoma.
- Active uncontrolled infection.
- Significant uncontrolled medical condition that may interfere with study participation.
- Active autoimmune disease requiring systemic treatment.
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 |
|---|---|---|
| SurovatamigAlso: AZD0486Fully human bispecific monoclonal immunoglobulins (Ig) G4 antibody | Drug | Surovatamig and R-CHOP |
| RituximabRituximab will be administered to participants as per SoC. | Drug | R-CHOP or Pola-R-CHP, Surovatamig and R-CHOP |
| CyclophosphamideCyclophosphamide will be administered to participants as per SoC. | Drug | R-CHOP or Pola-R-CHP, Surovatamig and R-CHOP |
| DoxorubicinDoxorubicin will be administered to participants as per SoC. | Drug | R-CHOP or Pola-R-CHP, Surovatamig and R-CHOP |
| VincristineVincristine will be administered to participants as per SoC. | Drug | R-CHOP or Pola-R-CHP, Surovatamig and R-CHOP |
| PrednisonePrednisone (or equivalent) will be administered to participants as per SoC. | Drug | R-CHOP or Pola-R-CHP, Surovatamig and R-CHOP |
| Polatuzumab vedotinPolatuzumab vedotin will be administered to participants as per SoC. | Drug | R-CHOP or Pola-R-CHP |
Primary outcome
Progression free survival (PFS) as assessed by Blinded Independent Central Review (BICR)
Time frame: Up to 10 years
The PFS is defined as the time from randomisation to the first occurrence of disease progression as determined by an Independent Review Committee (IRC), or death from any cause, whichever occurs first.
8 secondary outcomes
Overall survival (OS)
Time frame: Up to 10 years
PFS as assessed by the investigator
Time frame: Up to 10 years
Event-free survival efficacy (EFSeff)
Time frame: Up to 10 years
Overall response (OR) rate
Time frame: Up to 10 years
CR rate
Time frame: Up to 10 years
Duration of response (DoR)
Time frame: Up to 10 years
Duration of Complete Response (DOCR)
Time frame: Up to 10 years
Disease-free survival (DFS)
Time frame: Up to 10 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 2 Nov 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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surovatamig, Rituximab and Cyclophosphamide in people with Large B-cell Lymphoma, run by AstraZeneca.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Progression free survival (PFS) as assessed by Blinded Independent Central Review (BICR) (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.