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Not yet recruitingNCT07911553Soundtrack D3Updated Nov 2, 2026

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 interventional study of Surovatamig and Rituximab in Large B-cell Lymphoma, sponsored by AstraZeneca. Not yet recruiting. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Updated Nov 2, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study 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 the detailed description

This is an open-label, multicentre, randomised controlled study.

The study will have the following sequential periods:

  1. Screening period
  2. Treatment period
  3. 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)
02

Conditions studied

  • Large B-cell Lymphoma

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Keywords

  • IgG4 fully human CD19xCD3 bispecific T-cell engager
  • B-cell lymphoma
  • Polatuzumab vedotin
  • Prednisone
  • Rituximab
  • Cyclophosphamide
  • Vincristine
  • Doxorubicin
  • Surovatamig
03

In context

Lymphoma, B-Cell

885 studies on the registry are indexed under Lymphoma, B-Cell; 286 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 34 across 773 interventional studies indexed under Lymphoma, B-Cell.

Browse Lymphoma, B-Cell studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. confirmed previously untreated large B-cell lymphoma.
  2. IPI score of 2 to 5.
  3. .
  4. (ECOG) performance status 0 to 2.
  5. Adequate organ function.
  6. Availability of tumour tissue.
  7. Meets protocol-defined and pregnancy requirements.

Exclusion criteria

Exclusion Criteria

  1. Prior systemic treatment for large B-cell lymphoma.
  2. Primary or secondary central nervous system lymphoma.
  3. Active uncontrolled infection.
  4. Significant uncontrolled medical condition that may interfere with study participation.
  5. Active disease requiring systemic treatment.
  6. History of interstitial lung disease or pneumonitis.
  7. Pregnancy or breastfeeding.
  8. Known to study treatment components.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,200 participants (estimated)

Study arms

  • Experimental
    Surovatamig and R-CHOP

    Participants will receive surovatamig in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy according to standard of care (SoC).

    Drug: Surovatamig · Drug: Rituximab · Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Vincristine · Drug: Prednisone

  • Active comparator
    R-CHOP or Pola-R-CHP

    Participants will receive either R-CHOP or Pola-R-CHP (rituximab, cyclophosphamide, doxorubicin, prednisone \[or equivalent\]) and polatuzumab vedotin) according to SoC.

    Drug: Rituximab · Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Vincristine · Drug: Prednisone · Drug: Polatuzumab vedotin

Interventions

  • Fully human bispecific monoclonal immunoglobulins (Ig) G4 antibody

    Also known as: AZD0486

  • Rituximab will be administered to participants as per SoC.

  • Cyclophosphamide will be administered to participants as per SoC.

  • Doxorubicin will be administered to participants as per SoC.

  • Vincristine will be administered to participants as per SoC.

  • Prednisone (or equivalent) will be administered to participants as per SoC.

  • Polatuzumab vedotin will be administered to participants as per SoC.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 10 years

Secondary outcomes

  1. Overall survival (OS)

    The OS is defined as the time from randomisation to death due to any cause.

    Time frame: Up to 10 years

  2. 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.

    Time frame: Up to 10 years

  3. 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.

    Time frame: Up to 10 years

  4. 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.

    Time frame: Up to 10 years

  5. CR rate

    The CR is defined as the percentage of participants who achieve a CR, as assessed by the investigator and IRC separately.

    Time frame: Up to 10 years

  6. 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.

    Time frame: Up to 10 years

  7. 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.

    Time frame: Up to 10 years

  8. 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.

    Time frame: Up to 10 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan

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.

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07911553
Lead sponsor
AstraZeneca
Collaborators
Parexel
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Dec 22, 2026 (estimated)
Primary completion
Sep 2, 2030 (estimated)
Completion
Sep 1, 2032 (estimated)
Last update
Nov 2, 2026

Study contacts

AstraZeneca Clinical Study Information Center
Contact
information.center@astrazeneca.com
1-877-240-9479

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Surovatamig

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