Advanced or Metastatic Non-Small Cell Lung CancerPhase 3LATIFYNCT05450692
A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy
A Phase 3 study testing Ceralasertib, Durvalumab and Docetaxel in people with Advanced or Metastatic Non-Small Cell Lung Cancer, run by AstraZeneca at 191 sites in 23 countries.
Trial summary
This study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Advanced or Metastatic Non-Small Cell Lung Cancer
- What is being tested?
- Ceralasertib, Durvalumab and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 594 participants
- Where
- 191 sitesin 23 countries
- Study dates
- 15 Sep 2022to 31 Dec 2027
- 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 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.
- Documented epidermal growth receptor factor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type status as determined at a local laboratory.
- Documented radiological PD whilst on or after receiving the most recent treatment regimen.
- Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC either separately or in combination.
- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0 or 1.
- Adequate organ function and marrow reserve
Show all 9Show fewer
- Minimum life expectancy of 12 weeks.
- Body weight > 30 kg and no cancer-associated cachexia.
- Negative pregnancy test (serum test) for women of childbearing potential (WOCBP).
Who cannot join
- Participant with mixed SCLC and NSCLC histology.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention.
- Persistent toxicities (CTCAE Grade > 2) caused by previous anticancer therapy.
- Active or prior documented autoimmune or inflammatory disorders.
- Participants who have received more than one line of prior anti-PD-(L)1, either alone or in any combination.
- Participants:
Show all 12Show fewer
- Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy.
- All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved.
- Must not have experienced a Grade ≥ 3 immune-mediated adverse event (imAE) or an immune-related neurologic or ocular AE of any grade while receiving prior anti-PD(L)1 therapy.
- Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day.
- Participants who have received more than one prior line of platinum-based chemotherapy in metastatic setting.
- Participants who have received a prior ataxia telangiectasia and Rad3-related protein (ATR) inhibitor.
Trial locations and contacts
191 sites in 23 countries.
191 sites in 23 countries
United States27 sites
Research Site
Allentown, Pennsylvania, 18103
Research Site
Appleton, Wisconsin, 54911
Research Site
Athens, Georgia, 30607
Research Site
Atlanta, Georgia, 30318
Research Site
Baltimore, Maryland, 21231
Research Site
Bethesda, Maryland, 20817
Research Site
Canton, Ohio, 44718
Research Site
Chandler, Arizona, 85224
Research Site
Charlotte, North Carolina, 28204
Research Site
Cleveland, Ohio, 44106
Research Site
Fort Wayne, Indiana, 46804
Research Site
Hattiesburg, Mississippi, 39401
Research Site
Houston, Texas, 77090
Research Site
Huntsville, Texas, 77340
Research Site
Jacksonville, Florida, 32256
Research Site
Kingwood, Texas, 77339
Research Site
Los Alamitos, California, 90720
Research Site
Los Angeles, California, 90017
Research Site
Mobile, Alabama, 36607
Research Site
Omaha, Nebraska, 68114
Research Site
Orlando, Florida, 32804
Research Site
Reno, Nevada, 89511
Research Site
Rockville, Maryland, 20852
Research Site
St Louis, Missouri, 63110
Research Site
Whittier, California, 90603
Research Site
Winston-Salem, North Carolina, 27103
Research Site
York, Pennsylvania, 17403
China24 sites
Research Site
Baoding, 071000
Research Site
Beijing, 100021
Research Site
Beijing, 100044
Research Site
Changsha, 410008
Research Site
Chengdu, 610041
Research Site
Deyang, 618000
Research Site
Guangzhou, 510080
Research Site
Hangzhou, 310009
Research Site
Hefei, 230001
Research Site
Jinan, 250013
Research Site
Linyi, 276000
Research Site
Nanchang, 330000
Research Site
Nanjing, 210029
Research Site
Nanning, 530021
Research Site
Nashik, 422011
Research Site
Qingdao, 266071
Research Site
Taiyuan, 030000
Research Site
Tianjin, 300052
Research Site
Tianjin, 300060
Research Site
Wuhan, 430000
Research Site
Wuhan, 430022
Research Site
Wuhan, 430079
Research Site
Zhanjiang, 524001
Research Site
Zhengzhou, 450008
Spain18 sites
Research Site
A Coruña, 15006
Research Site
A Coruña, 15009
Research Site
Barcelona, 08041
Research Site
Barcelona, 8003
Research Site
Barcelona, 8035
Research Site
Castellon, 12002
Research Site
Córdoba, 14004
Research Site
Hospitalet deLlobregat, 08907
Research Site
Madrid, 28040
Research Site
Madrid, 28046
Research Site
Málaga, 29009
Research Site
Ourense, 32005
Research Site
Palma de Mallorca, 07198
Research Site
Pamplona, 31008
Research Site
Pozuelo de Alarcón, 28223
Research Site
Sabadell, 08208
Research Site
Servilla, 41014
Research Site
Zaragoza, 50009
Japan16 sites
Research Site
Bunkyō City, 113-8431
Research Site
Bunkyō City, 113-8677
Research Site
Chūōku, 104-0045
Research Site
Kōtoku, 135-8550
Research Site
Kurashiki-shi, 710-8602
Research Site
Kurume-shi, 830-0011
Research Site
Matsuyama, 791-0280
Research Site
Nagoya, 460-0001
Research Site
Niigata, 951-8566
Research Site
Osaka, 541-8567
Research Site
Sakaishi, 591-8555
Research Site
Sapporo, 003-0804
Research Site
Sendai, 980-0873
Research Site
Sunto-gun, 411-8777
Research Site
Toyoake-shi, 470-1192
Research Site
Yokohama, 241-8515
France14 sites
Research Site
Angers, 49933
Research Site
Clamart, 92140
Research Site
Clermont-Ferrand, 63011
Research Site
Créteil, 94010
Research Site
Lyon, 69373
Research Site
Montpellier, 34070
Research Site
Nantes, 44093
Research Site
Paris, 75014
Research Site
Pessac, 33604
Research Site
Saint-Herblain, 44805
Research Site
Saint-Quentin, 02321
Research Site
Vantoux, 57070
Research Site
Villefranche-sur-Saône, 69655
Research Site
Villejuif, 94805
Italy11 sites
Research Site
Aviano, 33081
Research Site
Livorno, 57124
Research Site
Meldola, 47014
Research Site
Milan, 20133
Research Site
Monza, 20900
Research Site
Naples, 80131
Research Site
Padova, 35128
Research Site
Parma, 43126
Research Site
Roma, 00128
Research Site
Rozzano, 20089
Research Site
Verona, 37126
Romania10 sites
Research Site
Bucharest, 022328
Research Site
Bucharest, 031422
Research Site
Cluj-Napoca, 400015
Research Site
Cluj-Napoca, 400641
Research Site
Craiova, 200347
Research Site
Craiova, 200385
Research Site
Floreşti, 407280
Research Site
Oradea, 410469
Research Site
Timișoara, 300166
Research Site
Timișoara, 300239
Canada7 sites
Research Site
Chicoutimi, Quebec, G7H 7P2
Research Site
Montreal, Quebec, H2L 4M1
Research Site
Montreal, Quebec, H3G 1A4
Research Site
Newmarket, Ontario, L3Y 2P9
Research Site
Québec, Quebec, G1V 4G5
Research Site
Rimouski, Quebec, G5L 5T1
Research Site
Vancouver, British Columbia, VSZ 4E6
Germany7 sites
Research Site
Berlin, 12351
Research Site
Freiburg im Breisgau, 79106
Research Site
Gauting, 82131
Research Site
Karlsruhe, 76137
Research Site
Kempten, 87439
Research Site
Löwenstein, 74245
Research Site
Moers, 47441
South Korea7 sites
Research Site
Cheongju-si, 28644
Research Site
Seoul, 03080
Research Site
Seoul, 03181
Research Site
Seoul, 03722
Research Site
Seoul, 07061
Research Site
Seoul, 138-736
Research Site
Suwon, 16247
Brazil6 sites
Research Site
Fortaleza, 60810-180
Research Site
Porto Alegre, 90110-270
Research Site
Porto Alegre, 90610-000
Research Site
Salvador, 40170-110
Research Site
São Paulo, 01246-000
Research Site
São Paulo, 09323-900
Taiwan6 sites
Research Site
Taichung, 40201
Research Site
Taichung, 40705
Research Site
Tainan, 704
Research Site
Taipei, 11217
Research Site
Taoyuan, 333423
Research Site
Yunlin, 640
Argentina5 sites
Research Site
Buenos Aires, 1058
Research Site
Pergamino, B2700CPM
Research Site
Rosario, S2000DSV
Research Site
Rosario, S2000KZE
Research Site
San Juan, 5400
Australia5 sites
Research Site
Elizabeth Vale, 5112
Research Site
Lismore, 2480
Research Site
Murdoch, 6150
Research Site
South Brisbane, 4101
Research Site
Wollongong, 2500
Poland5 sites
Research Site
Gdansk, 80-952
Research Site
Krakow, 30-727
Research Site
Krakow, 31-826
Research Site
Poznan, 60-693
Research Site
Skórzewo, 60-185
Belgium4 sites
Research Site
Charleroi, 6000
Research Site
Ghent, 9000
Research Site
Libramont-Chevigny, 6800
Research Site
Roeselare, 8800
Ireland4 sites
Research Site
Cork, T12 DV56
Research Site
Dublin, D09 V2N0
Research Site
Dublin
Research Site
Limerick, V94 F858
United Kingdom4 sites
Research Site
Guildford
Research Site
Metropolitan Borough of Wirral, CH63 4JY
Research Site
Stevenage, SG1 4AB
Research Site
Sutton, SM2 5PT
Hong Kong3 sites
Research Site
Hong Kong, 999077
Research Site
King's Park, 150001
Research Site
Tun Mun
India3 sites
Research Site
Jaipur, 302017
Research Site
Pune, 411001
Research Site
Surat, 395002
Netherlands2 sites
Research Site
Heerlen, 6419 PC
Research Site
Tilburg, 5022 GC
About this study
Official title: A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy: LATIFY
This study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy.
Read the detailed description
This study will consist of two treatment arms (Groups A and B).
Participants will be randomised in a 1:1 ratio to one of the two treatment groups:
- Group A: Ceralasertib plus durvalumab combination therapy Each 28-day cycle will begin with ceralasertib administered orally followed by durvalumab administered intravenously.
- Group B: Docetaxel monotherapy Each 21-day cycle will begin with the administration of docetaxel.
- Being tested
- Ceralasertib, Durvalumab, Docetaxel
- Keywords
- Durvalumab, Ceralasertib, Docetaxel, Lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeralasertibDrug
Participants will receive ceralasertib oral tablets.
DurvalumabDrug
Participants will receive durvalumab as an intravenous infusion.
DocetaxelDrug
Participants will received docetaxel as an intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Ceralasertib plus durvalumab combination therapy | Experimental | Participants will be administered ceralasertib orally followed by durvalumab administered intravenously. Receives: Drug: Ceralasertib; Drug: Durvalumab |
| Group B: Docetaxel monotherapy | Active comparator | Participants will be administered docetaxel (standard of care) administered intravenously. Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
The superiority of ceralasertib plus durvalumab combination therapy relative to docetaxel will be demonstrated by assessment of OS (HR with 95% CI and p-value) in participants with advanced NSCLC after second- or third-line therapy and without actionable genomic alterations. OS is defined as time from randomisation until the date of death due to any cause.
Measured: Every 3 months (± 1 week) following objective progression of disease (PD) or treatment discontinuation (up to three years)
Secondary outcomes (11)
Progression-Free Survival (PFS)
PFS will be defined as the time from the date of randomisation until the date of objective PD.
Measured: Up to 3 years
Objective Response Rate (ORR)
ORR is defined as the proportion of participant who have a Complete Response (CR) or Partial Response (PR) per RECIST 1.1.
Measured: Up to 3 years
Duration of Response (DoR)
DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1.
Measured: Up to 3 years
Time To Response (TTR)
TTR is defined as the time from randomisation until the date of first documented objective response.
Measured: Up to 3 years
Disease Control Rate (DCR)
DCR at 18 weeks is defined as the percentage of participants who have a CR or PR or who have stable disease (SD) for at least 17 weeks.
Measured: At Week 18
Time to second progression or death (PFS2)
Time from randomisation to PFS2 will be defined as the time from the randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death.
Measured: Up to 3 years
Overall Survival (OS) at 12 months
OS is defined as time from randomisation until the data of death due to any cause.
Measured: At 12 months
Time To Deterioration (TTD) of health-related quality of life (QoL)
TTD is defined as the time from randomisation until the date of first confirmed deterioration.
Measured: Up to 3 years
TTD of physical function
TTD in physical functioning is measured by the EORTC QLQ-C30 Physical Function subscale of the EORTC QLQ-C30.
Measured: Up to 3 years
Plasma concentrations for ceralasertib plus durvalumab combination therapy
The PK plasma concentration of ceralasertib when administered in combination with durvalumab will be assessed.
Measured: Up to 3 years
Number of participants with Adverse Evens (AEs)
The safety and tolerability of ceralasertib plus durvalumab combination therapy as compared with docetaxel will be assessed.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start15 Sep 2022
- Primary completion6 Oct 2025
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 594 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450692
- Sponsor's protocol ID
- D533BC00001
- Other IDs
- 2022-000493-26
- Acronym
- LATIFY
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2022
- Last updated
- 13 Jul 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. All request 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy: LATIFY
- ClinicalTrials.gov ID
- NCT05450692
- Acronym / sponsor ID
- LATIFY / D533BC00001
- Keywords
- Durvalumab, Ceralasertib, Docetaxel, Lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 594 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Jul 2022 (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 study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy.
Detailed description
This study will consist of two treatment arms (Groups A and B).
Participants will be randomised in a 1:1 ratio to one of the two treatment groups:
- Group A: Ceralasertib plus durvalumab combination therapy Each 28-day cycle will begin with ceralasertib administered orally followed by durvalumab administered intravenously.
- Group B: Docetaxel monotherapy Each 21-day cycle will begin with the administration of docetaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Ceralasertib plus durvalumab combination therapy | Experimental | Drug: Ceralasertib, Drug: DurvalumabParticipants will be administered ceralasertib orally followed by durvalumab administered intravenously. |
| Group B: Docetaxel monotherapy | Active comparator | Drug: DocetaxelParticipants will be administered docetaxel (standard of care) administered intravenously. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.
- Documented epidermal growth receptor factor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type status as determined at a local laboratory.
- Documented radiological PD whilst on or after receiving the most recent treatment regimen.
- Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC either separately or in combination.
- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0 or 1.
Key exclusion criteria (12 listed)
- Participant with mixed SCLC and NSCLC histology.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention.
- Persistent toxicities (CTCAE Grade > 2) caused by previous anticancer therapy.
- Active or prior documented autoimmune or inflammatory disorders.
- Participants who have received more than one line of prior anti-PD-(L)1, either alone or in any combination.
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 |
|---|---|---|
| CeralasertibParticipants will receive ceralasertib oral tablets. | Drug | Group A: Ceralasertib plus durvalumab combination therapy |
| DurvalumabParticipants will receive durvalumab as an intravenous infusion. | Drug | Group A: Ceralasertib plus durvalumab combination therapy |
| DocetaxelParticipants will received docetaxel as an intravenous infusion. | Drug | Group B: Docetaxel monotherapy |
Primary outcome
Overall Survival (OS)
Time frame: Every 3 months (± 1 week) following objective progression of disease (PD) or treatment discontinuation (up to three years)
The superiority of ceralasertib plus durvalumab combination therapy relative to docetaxel will be demonstrated by assessment of OS (HR with 95% CI and p-value) in participants with advanced NSCLC after second- or third-line therapy and without actionable genomic alterations. OS is defined as time from randomisation until the date of death due to any cause.
11 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 3 years
Objective Response Rate (ORR)
Time frame: Up to 3 years
Duration of Response (DoR)
Time frame: Up to 3 years
Time To Response (TTR)
Time frame: Up to 3 years
Disease Control Rate (DCR)
Time frame: At Week 18
Time to second progression or death (PFS2)
Time frame: Up to 3 years
Overall Survival (OS) at 12 months
Time frame: At 12 months
Time To Deterioration (TTD) of health-related quality of life (QoL)
Time frame: Up to 3 years
TTD of physical function
Time frame: Up to 3 years
Plasma concentrations for ceralasertib plus durvalumab combination therapy
Time frame: Up to 3 years
Number of participants with Adverse Evens (AEs)
Time frame: Up to 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 13 Jul 2026.
- Lung Cancer Study Locator details (for US)Link provided by the sponsor.
- 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. All request 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
191 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ceralasertib, Durvalumab and Docetaxel in people with Advanced or Metastatic Non-Small Cell Lung Cancer, run by AstraZeneca at 191 sites in 23 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 9 inclusion and 12 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 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 191 sites in United States, China, Spain, Japan, France and 18 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 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?
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?
Overall Survival (OS) (time frame: Every 3 months (± 1 week) following objective progression of disease (PD) or treatment discontinuation (up to three 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 13 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.