A Phase 3 interventional study of Surovatamig and R-CHOP in Untreated Follicular Lymphoma, sponsored by AstraZeneca. Recruiting at 244 sites in 25 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the Surovatamig (AZD0486) plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL.
The study consists of 2 sequential parts.
Phase III - The Phase III part will assess the superiority of Surovatamig (AZD0486) at RP3D in combination with rituximab, compared to Investigator's choice between 3 standard chemoimmunotherapy regimens. Phase 3 consists of 3 arms
1,891 studies on the registry are indexed under Lymphoma, Follicular; 290 are open to participants now.
This study's planned enrollment of 1,018 is above the median of 48 across 1,503 interventional studies indexed under Lymphoma, Follicular.
Browse Lymphoma, Follicular studies →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.
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.
The above is a summary, other inclusion criteria details may apply
Exclusion Criteria:
The above is a summary, other exclusion criteria details may apply
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.
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.
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.
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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Surovatamig regimen A plus rituximab
Drug: Surovatamig
Surovatamig regimen B plus rituximab
Drug: Surovatamig
Investigator's choice between 3 standard immunochemotherapy regimen (R-CHOP, R-CVP, or B-R followed by rituximab maintenance)
Drug: R-CHOP · Drug: R-CVP · Drug: BR
a fully human bispecific monoclonal IgG4 antibody
Also known as: AZD0486
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
Rituximab, Cyclophosphamide, Vincristine and Prednisone
Bendamustine, Rituximab
SRI Primary: Incidence, nature and severity of AEs and SAEs. Incidence and nature of study drug discontinuations, dose reductions, and dose delays due to AEs
Frequency, severity, and relationship to study drug of AEs and SAEs; dose modifications; changes in physical examination and safety procedures.
Time frame: Up to 10 years
SRI Primary: Determination of the recommended Phase III dose (RP3D)
The RP3D will be the dose of Surovatamig selected for the Phase 3 part based on safety data compiled during the safety run-in part
Time frame: Up to 1 year
Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy
PFS, based on Lugano 2014 Response Criteria, as assessed by BICR.
Time frame: Up to 10 years
Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy
ORR at EoI, based on Lugano 2014 Response Criteria, as assessed by BICR.
Time frame: Up to 10 years
Safety Run in and Phase 3: ORR at EoI (Investigator assessed)
ORR defined as the proportion of participants achieving either a PR or CR at End of Induction based on Lugano 2014 Response Criteria
Time frame: Up to 10 years
Safety Run In and Phase 3: CR Rate
CR rate is defined as the proportion of participants achieving a CR at any time as based on Lugano 2014 Response Criteria
Time frame: Up to 10 years
Safety Run In and Phase 3: CR at EoI
Proportion of participants achieving CR at End of Induction based on Lugano 2014 Response Criteria
Time frame: Up to 10 years
Safety Run In and Phase 3: DoR
DoR will be defined from the time of first response until progression based on Lugano 2014 criteria, or death due to any cause
Time frame: up to 10 years
Safety Run In and Phase 3: PFS (Investigator assessed)
PFS (Investigator assessed) is defined as time from randomization until disease progression based on Lugano 2014 Response Criteria or death due to any cause
Time frame: Up to 10 years
Safety Run In and Phase 3: OS
OS is defined as time until the date of death
Time frame: Up to 10 years
Phase 3: CR rate at 30 months (CR30)
Proportion of participants in CR rate at 30 months (CR30) based on Lugano 2014 Response Criteria
Time frame: Up to 30 months
Phase 3: Time to First Subsequent Therapy or Death (TFST)
TFST will be defined as the time from randomization until the start date of first subsequent anti-lymphoma therapy or death due to any cause
Time frame: Up to 10 Years
Phase 3: Time from randomisation to second progression or death (PFS2)
PFS2 will be defined as the time from randomization until the earliest of the progression event, after first subsequent therapy, or death due to any cause
Time frame: Up to 10 Years
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Showing the first 100 of 244 sites across 25 countries. Choose a country and city above to see the rest.
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. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma 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. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
No publications or documents are linked to this record.
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 ↗
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Studies of the drug tested here: Surovatamig