Non-small Cell Lung CancerPhase 2MDT-BRIDGENCT05925530
Study to Assess Neoadjuvant Durvalumab (D) and Platinum-Based Chemotherapy (CT), Followed by Either Surgery and Adjuvant D or CRT and Consolidation D, in Resectable or Borderline Resectable Stage IIB-IIIB NSCLC (MDT-BRIDGE)
A Phase 2 study testing Durvalumab in people with Non-small Cell Lung Cancer, run by AstraZeneca at 49 sites in 11 countries.
Trial summary
The purpose of this study is to assess efficacy and safety of neoadjuvant durvalumab in combination with platinum-based chemotherapy (CT) given as initial therapy after cancer diagnosis followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT) and consolidation durvalumab given alone as further… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Durvalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 49 sitesin 11 countries
- Study dates
- 22 Feb 2024to 27 Aug 2027
- 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Deemed resectable or borderline resectable at baseline, confirmed by MDT evaluation at diagnosis.
- Previously untreated and pathologically confirmed Stage IIB to select [i.e.N2] Stage IIIB by AJCC v8.
- Nodal status confirmed with whole body FDG-PET and biopsy via endobronchial ultrasound, mediastinoscopy, or thoracoscopy.
- Mandatory brain MRI.
- EGFR and ALK wild-type.
- Medically operable: adequate cardiac and lung function to undergo resection.
Show all 12Show fewer
- Participant must be ≥ 18 years, at the time of screening.
- Histologically or cytologically documented NSCLC.
- Minimum life expectancy of 12 weeks.
- Minimum body weight of 30 kg.
- Male and female participants must be willing to use acceptable methods of contraception.
- Female participants of childbearing potential must have negative pregnancy test.
Who cannot join
- Unresectable NSCLC confirmed by MDT evaluation at baseline
- Stage IIIC patients
- Participants whose planned surgery at enrollment is a wedge resection
- Known EGFR mutation or ALK translocation
- Participants contraindicated for surgical intervention due to comorbid conditions
- Participants who are allergic to study intervention.
Show all 11Show fewer
- Participants with more than one primary tumour.
- Known active hepatitis infection, positive HCV antibody, HBsAg or HBV core antibody (anti-HBc), at screening.
- Female participants who are pregnant or breastfeeding.
- Judgement by the investigator that the participant should not participate in the study.
- Previously infected or tested positive for human immunodeficiency virus.
Trial locations and contacts
49 sites in 11 countries.
49 sites in 11 countries
Italy9 sites
Research Site
Bari, 70124
Research Site
Bologna, 40138
Research Site
Milan, 20132
Research Site
Milan, 20133
Research Site
Milan, 20141
Research Site
Naples, 80131
Research Site
Palermo, 90127
Research Site
Pavia, 27100
Research Site
Peschiera del Garda, 37019
Spain9 sites
Research Site
Barakaldo, 48903
Research Site
Barcelona, 08025
Research Site
L'Hospitalet de Llobregat, 08908
Research Site
Madrid, 28007
Research Site
Madrid, 28027
Research Site
Madrid, 28046
Research Site
Pamplona, 31008
Research Site
Valencia, 46009
Research Site
Zaragoza, 50009
France8 sites
Research Site
La Tronche, 38700
Research Site
Marseille, 13008
Research Site
Montpellier, 34295
Research Site
Mulhouse, 68070
Research Site
Paris, 75005
Research Site
Pessac, 33604
Research Site
Poitiers, 86000
Research Site
Toulouse, 31059
Germany5 sites
Research Site
Berlin, 13125
Research Site
Cologne, 51109
Research Site
Großhansdorf, 22927
Research Site
Moers, 47441
Research Site
Würzburg, 97074
Czechia4 sites
Research Site
Brno, 625 00
Research Site
Olomouc, 77900
Research Site
Prague, 12808
Research Site
Prague, 150 06
United States3 sites
Research Site
Charlottesville, Virginia, 22908
Research Site
Houston, Texas, 77030
Research Site
The Bronx, New York, 10467
Canada3 sites
Research Site
Chicoutimi, Quebec, G7H 5H6
Research Site
Kingston, Ontario, K7L 2V7
Research Site
Montreal, Quebec, H4A 3J1
About this study
Official title: A Multicentre, Phase II, Single-Arm, Interventional Study of Neoadjuvant Durvalumab and Platinum-based Chemotherapy (CT), Followed by Either Surgery and Adjuvant Durvalumab or Chemoradiotherapy (CRT) and Consolidation Durvalumab, in Participants With Resectable or Borderline Resectable Stage IIB-IIIB Non-small Cell Lung Cancer (NSCLC)
The purpose of this study is to assess efficacy and safety of neoadjuvant durvalumab in combination with platinum-based chemotherapy (CT) given as initial therapy after cancer diagnosis followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT) and consolidation durvalumab given alone as further therapy in participants with resectable and borderline resectable stage IIB-IIIB NSCLC.
Read the detailed description
This will be a multicentre, Phase II, single-arm, global study assessing the efficacy and safety of neoadjuvant durvalumab and platinum-based CT, given intravenously, followed by either surgery and adjuvant durvalumab or definitive CRT and consolidation durvalumab in participants with resectable and borderline resectable stage IIB-IIIB NSCLC.
Neoadjuvant Period A:
All participants will initially receive 2 cycles of neoadjuvant durvalumab + CT (investigator's choice platinum-based) every three weeks. Participants will be assessed for resectability by a multidisciplinary team.
Neoadjuvant Period B:
Cohort 1: Participants who are deemed eligible for surgery will receive study intervention every three weeks for an additional one and up to two cycles, followed by surgery.
CRT:
Cohort 2: Participants with unresectable tumours (according to MDT re-assessment) will receive definitive CRT (6 one-week cycles) for approximately six weeks.
Both cohorts will then go on to receive durvalumab every four weeks until disease progression or recurrence or up to one year.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Durvalumab
- Keywords
- Neoadjuvant, Durvalumab, Chemoradiotherapy, Surgery, Adjuvant, Consolidation, Multidisciplinary team (MDT)
- 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.
DurvalumabDrug
Also called MEDI4736
Participants that go on to receive surgery, will receive durvalumab for up to four cycles prior to surgery. Participants that go on to receive CRT will receive durvalumab for up to two cycles prior to CRT. All participants will receive durvalumab every four weeks until disease progression or recurrence or up to 12 months following surgery/CRT, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab | Experimental | Durvalumab will be administered to the participants via intravenous infusion (IV) Receives: Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resection rate
Resection rate is defined as the proportion of all participants who underwent definitive surgery. Participants who undergo (ie, start) surgery with the goal of complete tumour resection will be counted as meeting this endpoint.
Measured: At day of surgery (Within 40 days of the last dose of neoadjuvant treatment)
Secondary outcomes (23)
Resection rate
Resection rate will be further assessed separately in participants deemed resectable at baseline and participants deemed borderline resectable at baseline.
Measured: At the day of surgery (within 40 days after the last dose of neoadjuvant treatment)
R0, R1, R2 resection rates
The R0, R1, and R2 resection rates (assessed separately) are defined as the proportion of resected participants with resection margins assessed as R0, R1, and R2 respectively. R0 corresponds to resection for cure or complete remission, R1 to microscopic residual tumour, R2 to macroscopic residual tumour.
Measured: At the day of surgery (within 40 days after the last dose of neoadjuvant treatment)
Pathological complete response (pCR)
pCR will be defined as the proportion of participants who undergo surgery and have 0% residual viable tumour cells in resected lung and lymph nodes.
Measured: At the day of surgery (within 40 days after the last dose of neoadjuvant treatment)
Overall Survival (OS)
OS will be defined as the time from first dose of study intervention until the date of death due to any cause.
Measured: From first dose of study intervention until death, withdrawal of consent, or the end of the study (approximately 3.5 years)
Overall Survival (OS) rate
The proportion of participants alive at 12 and 24 months.
Measured: At 12 months and 24 months
Event-free survival (EFS)
EFS is defined as the time from the first dose of study intervention to any of the following events: PD that precludes surgery, progression or recurrence of disease after surgery, PD in the absence of surgery, disease progression, recurrence, or death due to any cause.
Measured: From first dose of study intervention until progression of disease (PD), recurrence or death, withdrawal of consent, or the end of the study (approximately 3.5 years)
Event-free survival (EFS) rate
The proportion of participants alive and event-free at 12 and 24 months.
Measured: At 12 months and 24 months
Progression Free Survival (PFS)
PFS is defined as the time from the first dose of study intervention to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.-defined PD, as assessed by the investigator, or death due to any cause.
Measured: From first dose of study intervention until disease progression, death, withdrawal of consent, or the end of the study (approximately 3.5 years)
Progression Free Survival (PFS) rate
The proportion of participants alive without disease progression at 12 and 24 months.
Measured: At 12 months and 24 months
Objective response rate (ORR) pre-surgery/pre-chemoradiotherapy (CRT)
ORR is defined as the proportion of participants who have unconfirmed complete response or partial response as assessed by the investigator per RECIST 1.1.
Measured: From first dose of study intervention until death, surgery/start of CRT
ORR during study intervention and definitive CRT
ORR is defined as the proportion of participants who have unconfirmed complete response or partial response as assessed by the investigator per RECIST 1.1.
Measured: From MDT re-assessment timepoint (baseline for this endpoint) until the first tumour assessment after definitive CRT
Percentage of all participants with circulating tumor DNA (ctDNA) clearance
Circulating tumour DNA clearance (ie, cMR) will be defined as a change from detectable ctDNA to undetectable ctDNA (ctDNA concentration less than limit of detection) at specified timepoints. The percentage of all biomarker-evaluable participants with ctDNA clearance will be assessed.
Measured: From Cycle 1 Day 1 up to pre-surgery/CRT (within 7 to 14 days pre-surgery/CRT) [Each cycle is of 3 weeks]
Number of participants with adverse events
Safety and tolerability will be evaluated in terms of adverse events and serious adverse events.
Measured: From enrollment up to at least 90 days after last dose of study intervention
Surgical safety: Duration of surgical procedure
The safety of study intervention will be evaluated from start to end of surgery
Measured: Time from start of surgery to end of surgery
Surgical safety: Length of post operative hospital stay
The safety of study intervention will be evaluated during post operative hospital stay
Measured: Time from the beginning of the surgery/procedure to the discharge of hospital
Surgical safety: Intended surgical approach
Intended surgical approach at baseline (minimally invasive vs open thoracotomy).
Measured: At baseline
Surgical safety: Actual surgical approach
Actual surgical approach (minimally invasive vs open thoracotomy).
Measured: At surgery
Surgical safety: Intended surgical procedure
Intended surgical procedure (lobectomy vs bilobectomy vs sleeve resection vs pneumonectomy).
Measured: At baseline
Surgical safety: Actual surgical procedure
Actual surgical procedure (lobectomy vs bilobectomy vs sleeve resection vs pneumonectomy)
Measured: At surgery
Number of participants with delayed surgery
The safety of study intervention will be evaluated for participants with delayed surgery
Measured: 40 days after last dose of study intervention to surgery
Surgical safety: Length of surgical delays
The safety of study intervention will be evaluated during the length of the surgical delay
Measured: 40 days after last dose of study intervention to surgery
Number of participants with reason of surgical delay
The safety of study intervention will be evaluated for participants with reason of surgical delay
Measured: 40 days after last dose of study intervention to surgery
Time from last neoadjuvant dose to surgery
The safety of the study intervention will be evaluated from last neoadjuvant dose to surgery
Measured: Time from last neoadjuvant dose of study intervention to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start22 Feb 2024
- Primary completion12 Jan 2026
- Study completion27 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925530
- Sponsor's protocol ID
- D9106C00002
- Other IDs
- 2023-503357-35-00, 2023
- Acronym
- MDT-BRIDGE
- Status last verified
- Sep 2026
- First submitted
- 22 Jun 2023
- Last updated
- 9 Sep 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 approved.
Publications
Reck M, Nadal E, Gay CM, Girard N, Filippi AR, Martin LW, Petersen C, Cairns DA, Majem M, Ardizzoni A, Alvarez RA, Robinson A, Roch B, Boyer A, Attili I, Diehn M, Kurtz D, Emeribe UA, Perez ID, Levra MG, Gale D, Zhu Z, Georgoulia N, Spicer J. Neoadjuvant durvalumab plus chemotherapy in resectable or borderline resectable non-small-cell lung cancer: the phase 2 MDT-BRIDGE trial. Nat Med. 2026 Oct 26. doi: 10.1038/s41591-026-04742-7. Online ahead of print.
PubMed 42934326
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Phase II, Single-Arm, Interventional Study of Neoadjuvant Durvalumab and Platinum-based Chemotherapy (CT), Followed by Either Surgery and Adjuvant Durvalumab or Chemoradiotherapy (CRT) and Consolidation Durvalumab, in Participants With Resectable or Borderline Resectable Stage IIB-IIIB Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT05925530
- Acronym / sponsor ID
- MDT-BRIDGE / D9106C00002
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Neoadjuvant, Durvalumab, Chemoradiotherapy, Surgery, Adjuvant, Consolidation, Multidisciplinary team (MDT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 142 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 27 Aug 2027 (estimated)
- First posted
- 29 Jun 2023 (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.
The purpose of this study is to assess efficacy and safety of neoadjuvant durvalumab in combination with platinum-based chemotherapy (CT) given as initial therapy after cancer diagnosis followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT) and consolidation durvalumab given alone as further therapy in participants with resectable and borderline resectable stage IIB-IIIB NSCLC.
Detailed description
This will be a multicentre, Phase II, single-arm, global study assessing the efficacy and safety of neoadjuvant durvalumab and platinum-based CT, given intravenously, followed by either surgery and adjuvant durvalumab or definitive CRT and consolidation durvalumab in participants with resectable and borderline resectable stage IIB-IIIB NSCLC.
Neoadjuvant Period A:
All participants will initially receive 2 cycles of neoadjuvant durvalumab + CT (investigator's choice platinum-based) every three weeks. Participants will be assessed for resectability by a multidisciplinary team.
Neoadjuvant Period B:
Cohort 1: Participants who are deemed eligible for surgery will receive study intervention every three weeks for an additional one and up to two cycles, followed by surgery.
CRT:
Cohort 2: Participants with unresectable tumours (according to MDT re-assessment) will receive definitive CRT (6 one-week cycles) for approximately six weeks.
Both cohorts will then go on to receive durvalumab every four weeks until disease progression or recurrence or up to one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalumab | Experimental | Drug: DurvalumabDurvalumab will be administered to the participants via intravenous infusion (IV) |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Deemed resectable or borderline resectable at baseline, confirmed by MDT evaluation at diagnosis.
- Previously untreated and pathologically confirmed Stage IIB to select [i.e.N2] Stage IIIB by AJCC v8.
- Nodal status confirmed with whole body FDG-PET and biopsy via endobronchial ultrasound, mediastinoscopy, or thoracoscopy.
- Mandatory brain MRI.
- EGFR and ALK wild-type.
Key exclusion criteria (11 listed)
- Unresectable NSCLC confirmed by MDT evaluation at baseline
- Stage IIIC patients
- Participants whose planned surgery at enrollment is a wedge resection
- Known EGFR mutation or ALK translocation
- Participants contraindicated for surgical intervention due to comorbid conditions
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 |
|---|---|---|
| DurvalumabAlso: MEDI4736Participants that go on to receive surgery, will receive durvalumab for up to four cycles prior to surgery. Participants that go on to receive CRT will receive durvalumab for up to two cycles prior to CRT. All participants will receive durvalumab every four weeks until disease progression or recurrence or up to 12 months following surgery/CRT, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. | Drug | Durvalumab |
Primary outcome
Resection rate
Time frame: At day of surgery (Within 40 days of the last dose of neoadjuvant treatment)
Resection rate is defined as the proportion of all participants who underwent definitive surgery. Participants who undergo (ie, start) surgery with the goal of complete tumour resection will be counted as meeting this endpoint.
23 secondary outcomes
Resection rate
Time frame: At the day of surgery (within 40 days after the last dose of neoadjuvant treatment)
R0, R1, R2 resection rates
Time frame: At the day of surgery (within 40 days after the last dose of neoadjuvant treatment)
Pathological complete response (pCR)
Time frame: At the day of surgery (within 40 days after the last dose of neoadjuvant treatment)
Overall Survival (OS)
Time frame: From first dose of study intervention until death, withdrawal of consent, or the end of the study (approximately 3.5 years)
Overall Survival (OS) rate
Time frame: At 12 months and 24 months
Event-free survival (EFS)
Time frame: From first dose of study intervention until progression of disease (PD), recurrence or death, withdrawal of consent, or the end of the study (approximately 3.5 years)
Event-free survival (EFS) rate
Time frame: At 12 months and 24 months
Progression Free Survival (PFS)
Time frame: From first dose of study intervention until disease progression, death, withdrawal of consent, or the end of the study (approximately 3.5 years)
Progression Free Survival (PFS) rate
Time frame: At 12 months and 24 months
Objective response rate (ORR) pre-surgery/pre-chemoradiotherapy (CRT)
Time frame: From first dose of study intervention until death, surgery/start of CRT
ORR during study intervention and definitive CRT
Time frame: From MDT re-assessment timepoint (baseline for this endpoint) until the first tumour assessment after definitive CRT
Percentage of all participants with circulating tumor DNA (ctDNA) clearance
Time frame: From Cycle 1 Day 1 up to pre-surgery/CRT (within 7 to 14 days pre-surgery/CRT) [Each cycle is of 3 weeks]
Number of participants with adverse events
Time frame: From enrollment up to at least 90 days after last dose of study intervention
Surgical safety: Duration of surgical procedure
Time frame: Time from start of surgery to end of surgery
Surgical safety: Length of post operative hospital stay
Time frame: Time from the beginning of the surgery/procedure to the discharge of hospital
Surgical safety: Intended surgical approach
Time frame: At baseline
Surgical safety: Actual surgical approach
Time frame: At surgery
Surgical safety: Intended surgical procedure
Time frame: At baseline
Surgical safety: Actual surgical procedure
Time frame: At surgery
Number of participants with delayed surgery
Time frame: 40 days after last dose of study intervention to surgery
Surgical safety: Length of surgical delays
Time frame: 40 days after last dose of study intervention to surgery
Number of participants with reason of surgical delay
Time frame: 40 days after last dose of study intervention to surgery
Time from last neoadjuvant dose to surgery
Time frame: Time from last neoadjuvant dose of study intervention to surgery
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 9 Sep 2026.
- Derived from this study: PubMed 42934326Reck M, Nadal E, Gay CM, Girard N, Filippi AR, Martin LW, Petersen C, Cairns DA, Majem M, Ardizzoni A, Alvarez RA, Robinson A, Roch B, Boyer A, Attili I, Diehn M, Kurtz D, Emeribe UA, Perez ID, Levra MG, Gale D, Zhu Z, Georgoulia N, Spicer J. Neoadjuvant durvalumab plus chemotherapy in resectable or borderline resectable non-small-cell lung cancer: the phase 2 MDT-BRIDGE trial. Nat Med. 2026 Oct 26. doi: 10.1038/s41591-026-04742-7. Online ahead of print.
- 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 approved.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
49 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab in people with Non-small Cell Lung Cancer, run by AstraZeneca at 49 sites in 11 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 12 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Italy, Spain, France, Germany, Czechia and 6 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resection rate (time frame: At day of surgery (Within 40 days of the last dose of neoadjuvant treatment)). 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 NCT05925530, which also lists 1 linked publication.
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 9 Sep 2026.