Non Small Cell Lung Cancer MetastaticPhase 1ARC-4NCT03846310
A Study to Evaluate Immunotherapy Combinations in Participants With Lung Cancer
A Phase 1 study testing Etrumadenant, Zimberelimab and Carboplatin in people with Non Small Cell Lung Cancer Metastatic and Non Small Cell Lung Cancer, run by Arcus Biosciences, Inc. at 22 sites in 4 countries.
Trial summary
This is a Phase 1/1b, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and clinical activity of etrumadenant (AB928) in combination with carboplatin and pemetrexed, with or without an anti-PD-1 antibody (pembrolizumab or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer, Nonsquamous Nonsmall Cell Neoplasm of Lung
- What is being tested?
- Etrumadenant, Zimberelimab and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 1 Apr 2019to 18 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants; age ≥ 18 years
- Pathologically confirmed nonsquamous NSCLC that is metastatic, locally advanced, or recurrent with progression
- Arm A participants must fulfill one of the following:
- Participant has a genetic alteration (mutation or rearrangement) and has received all available targeted therapy. Previous treatment with chemotherapy or PD-1/-L1 therapy is not allowed.
- Participant has not received any therapy for the disease under study and standard therapy is refused.
- Participant has progressed on PD-1/-L1 therapy (monotherapy or combination regimen). Previous treatment with chemotherapy is not allowed.
Show all 19Show fewer
- Participant has progressed on PD-1/-L1 therapy (monotherapy or combination regimen) and has received less than 4 cycles of carboplatin/pemetrexed and further chemotherapy is appropriate.
- Participant has received any number of prior treatments and is without alternative or curative therapy.
- Arm B participants must fulfill one of the following:
- Participant has a genetic alteration (mutation or rearrangement) and has received all available targeted therapy. Previous treatment with chemotherapy or PD-1/-L1 therapy is not allowed.
- Participant has not received any therapy for the disease under study and standard therapy is refused.
- Participant has received any number of prior treatments and is without alternative or curative therapy.
- Arm 1 and Arm 2 participants must have a sensitizing epidermal growth factor receptor (EGFR) mutation with disease progression or treatment intolerance after one or more approved TKIs. Previous treatment with chemotherapy or PD-1/L-1 therapy is not allowed.
- No TKI therapy within 5 days of Cycle 1 Day 1
- The last dose of previous investigational therapy is at least 4 weeks or 5 half-lives prior to Cycle 1 Day 1.
- Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Confirm that an archival tissue sample is available and ≤ 24 months old; if not, a new biopsy of a tumor lesion should be obtained at screening
- Adequate organ and marrow function
Who cannot join
- Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational product
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 30 days after the last dose of etrumadenant, 90 days after the last dose of zimberelimab or pembrolizumab, or 6 months after the last dose of pemetrexed, whichever is longer
- Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy
- Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer
- Prior use of an adenosine pathway targeting agent
- Due to potential for drug-drug interactions with etrumadenant, participants must not have had:
- Treatment with breast cancer resistance protein substrates or P-glycoprotein with a narrow therapeutic window, administered orally within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment.
- Treatment with known strong cytochrome P450 3A4 (CYP3A4) inducers and strong CYP3A4 inhibitors within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
United States8 sites
USO Texas Oncology - Dallas (Baylor Charles A. Sammons Cancer Center)
Dallas, Texas, 75246
USO Virginia Cancer Specialist
Fairfax, Virginia, 22031
SCRI Florida Cancer Specialists - South
Fort Myers, Florida, 33901
SCRI Tennessee Oncology - Nashville
Nashville, Tennessee, 37203
USO Virginia Oncology Associates
Norfolk, Virginia, 23502
Medical Oncology Associates/Summit Cancer Center
Spokane, Washington, 99208
SCRI Florida Cancer Specialists - North
Tavares, Florida, 33705
Arizona Cancer Research Center (ACRC)
Tucson, Arizona, 85715
South Korea7 sites
Chungbuk National University Hospital
Cheongju-si, 28644
Bundang CHA Medical Center
Seongnam-si, 13496
Severance Hospital, Yonsei University Health System
Seoul, 3722
Asan Medical Centre
Seoul, 5505
Seoul St. Mary's Hospital
Seoul, 6591
The Catholic University of Korea St. Vincent Hospital
Suwon, Gyeonggi-do, 16247
Seoul National University Hospital
Suwon, 3080
Taiwan5 sites
Changhua Christian Hospital
Changhua, 500
Taipei Medical University - Shuang Ho Hospital
New Taipei City, 23561
Chi Mei Hospital, Liouying
Tainan, 73657
National Taiwan University Hospital
Taipei, 10002
Tri Service General Hospital
Taipei, 11490
Singapore2 sites
National University Hospital
Singapore, 119228
National Cancer Centre Singapore
Singapore, 169610
About this study
Official title: A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Lung Cancer
This is a Phase 1/1b, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and clinical activity of etrumadenant (AB928) in combination with carboplatin and pemetrexed, with or without an anti-PD-1 antibody (pembrolizumab or zimberelimab), in participants with non-squamous Non-Small Cell Lung Cancer (NSCLC).
Read the detailed description
In the dose-escalation phase, escalating doses of etrumadenant in combination with carboplatin and pemetrexed at standard doses (Arm A), and etrumadenant in combination with carboplatin, pemetrexed and pembrolizumab (Arm B), may be assessed in participants with advanced NSCLC. Eligible participants will receive oral administration of etrumadenant as well as IV infused carboplatin, pemetrexed, with or without pembrolizumab in this phase. The recommended dose for expansion (RDE) of etrumadenant will be determined upon completion of the dose-escalation phase.
In the dose-expansion phase, zimberelimab in combination with carboplatin and pemetrexed (Arm 1), and etrumadenant at RDE in combination with carboplatin, pemetrexed, and zimberelimab (Arm 2) may be assessed in eligible NSCLC participants who harbor an EGFR mutation and have progressed on EGFR Tyrosine Kinase Inhibitor (TKI) treatment(s).
Overall duration of treatment will depend on how well the treatment is tolerated.
Treatment may continue until unacceptable toxicity or progressive disease or other reasons specified in the protocol.
- Conditions
- Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer, Nonsquamous Nonsmall Cell Neoplasm of Lung, Sensitizing EGFR Gene Mutation
- Being tested
- Etrumadenant, Zimberelimab, Carboplatin, Pemetrexed, Pembrolizumab
- 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.
EtrumadenantDrug
Also called AB928
Etrumadenant is an A2aR and A2bR antagonist
ZimberelimabDrug
Also called AB122
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
CarboplatinDrug
Carboplatin administered as part of standard chemotherapy regimen
PemetrexedDrug
Pemetrexed administered as part of standard chemotherapy regimen
PembrolizumabDrug
Pembrolizumab is a humanized anti-PD-1 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Arm A | Experimental | Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The RDE of etrumadenant will be determined in this part with escalating doses of etrumadenant in combination with standard doses of carboplatin/pemetrexed chemotherapy regimen in participants with Non-Small Cell Lung Cancer. Receives: Drug: Etrumadenant; Drug: Carboplatin; Drug: Pemetrexed |
| Dose Escalation Arm B | Experimental | Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The RDE of etrumadenant will be determined in this part with escalating doses of etrumadenant in combination with standard doses of carboplatin/pemetrexed chemotherapy regimen and pembrolizumab in participants with Non-Small Cell Lung Cancer. Receives: Drug: Etrumadenant; Drug: Carboplatin; Drug: Pemetrexed; Drug: Pembrolizumab |
| Dose Expansion Arm 1 | Experimental | Zimberelimab will be administered in combination with standard carboplatin and pemetrexed chemotherapy regimen in participants with Non-Small Cell Lung Cancer harboring a sensitizing EGFR mutation. Receives: Drug: Zimberelimab; Drug: Carboplatin; Drug: Pemetrexed |
| Dose Expansion Arm 2 | Experimental | The etrumadenant at RDE determined from the dose escalation phase will be administered in combination with standard carboplatin and pemetrexed chemotherapy regimen and zimberelimab in participants with Non-Small Cell Lung Cancer harboring a sensitizing EGFR mutation. Receives: Drug: Etrumadenant; Drug: Zimberelimab; Drug: Carboplatin; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with Adverse Events
Measured: From first study treatment administration until up to 90 days after the last dose (Approximately 1 year)
Percentage of participants who experience a Dose Limiting Toxicity
Measured: From first study treatment administration through Day 21
Secondary outcomes (7)
Percentage of participants with anti-drug antibodies to zimberelimab
Measured: Recorded at baseline (screening), during the first 4 cycles of treatment (4 months) and 30 days post last dose (i.e. in total approximately 5 months).
Plasma concentration of etrumadenant
Measured: Recorded at baseline (screening), during the first 4 cycles of treatment (4 months) and 30 days post last dose (i.e. in total approximately 5 months).
Serum concentration of zimberelimab
Measured: Recorded at baseline (screening), during the first 4 cycles of treatment (4 months) and 30 days post last dose (i.e. in total approximately 5 months).
Progression Free Survival (PFS)
Measured: From start of treatment up to the first occurrence of progressive disease or death from any cause, whichever occurs first (up to approximately 3-5 years)
Duration of Response
Measured: From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
Percentage of Participants with Disease Control (complete response, partial response, or stable disease) for >6 months
Measured: From study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years)
Percentage of participants with Objective Response
Measured: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 3-5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start1 Apr 2019
- Primary completion18 Nov 2024
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer MetastaticStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3+3 dose escalation
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcus Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Arcus Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846310
- Sponsor's protocol ID
- ARC-4 (AB928CSP0004)
- Acronym
- ARC-4
- Status last verified
- May 2024
- First submitted
- 14 Feb 2019
- Last updated
- 9 Dec 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Lung Cancer
- ClinicalTrials.gov ID
- NCT03846310
- Acronym / sponsor ID
- ARC-4 / ARC-4 (AB928CSP0004)
- Conditions
- Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer, Nonsquamous Nonsmall Cell Neoplasm of Lung, Sensitizing EGFR Gene Mutation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Arcus Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 19 Feb 2019 (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 Phase 1/1b, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and clinical activity of etrumadenant (AB928) in combination with carboplatin and pemetrexed, with or without an anti-PD-1 antibody (pembrolizumab or zimberelimab), in participants with non-squamous Non-Small Cell Lung Cancer (NSCLC).
Detailed description
In the dose-escalation phase, escalating doses of etrumadenant in combination with carboplatin and pemetrexed at standard doses (Arm A), and etrumadenant in combination with carboplatin, pemetrexed and pembrolizumab (Arm B), may be assessed in participants with advanced NSCLC. Eligible participants will receive oral administration of etrumadenant as well as IV infused carboplatin, pemetrexed, with or without pembrolizumab in this phase. The recommended dose for expansion (RDE) of etrumadenant will be determined upon completion of the dose-escalation phase.
In the dose-expansion phase, zimberelimab in combination with carboplatin and pemetrexed (Arm 1), and etrumadenant at RDE in combination with carboplatin, pemetrexed, and zimberelimab (Arm 2) may be assessed in eligible NSCLC participants who harbor an EGFR mutation and have progressed on EGFR Tyrosine Kinase Inhibitor (TKI) treatment(s).
Overall duration of treatment will depend on how well the treatment is tolerated.
Treatment may continue until unacceptable toxicity or progressive disease or other reasons specified in the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 3+3 dose escalation
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Arm A | Experimental | Drug: Etrumadenant, Drug: Carboplatin, Drug: PemetrexedDose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The RDE of etrumadenant will be determined in this part with escalating doses of etrumadenant in combination with standard doses of carboplatin/pemetrexed chemotherapy regimen in participants with Non-Small Cell Lung Cancer. |
| Dose Escalation Arm B | Experimental | Drug: Etrumadenant, Drug: Carboplatin, Drug: Pemetrexed, Drug: PembrolizumabDose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The RDE of etrumadenant will be determined in this part with escalating doses of etrumadenant in combination with standard doses of carboplatin/pemetrexed chemotherapy regimen and pembrolizumab in participants with Non-Small Cell Lung Cancer. |
| Dose Expansion Arm 1 | Experimental | Drug: Zimberelimab, Drug: Carboplatin, Drug: PemetrexedZimberelimab will be administered in combination with standard carboplatin and pemetrexed chemotherapy regimen in participants with Non-Small Cell Lung Cancer harboring a sensitizing EGFR mutation. |
| Dose Expansion Arm 2 | Experimental | Drug: Etrumadenant, Drug: Zimberelimab, Drug: Carboplatin, Drug: PemetrexedThe etrumadenant at RDE determined from the dose escalation phase will be administered in combination with standard carboplatin and pemetrexed chemotherapy regimen and zimberelimab in participants with Non-Small Cell Lung Cancer harboring a sensitizing EGFR mutation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female participants; age ≥ 18 years
- Pathologically confirmed nonsquamous NSCLC that is metastatic, locally advanced, or recurrent with progression
- Arm A participants must fulfill one of the following:
- Arm B participants must fulfill one of the following:
- Arm 1 and Arm 2 participants must have a sensitizing epidermal growth factor receptor (EGFR) mutation with disease progression or treatment intolerance after one or more approved TKIs. Previous treatment with chemotherapy or PD-1/L-1 therapy is not allowed.
Key exclusion criteria (8 listed)
- Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational product
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 30 days after the last dose of etrumadenant, 90 days after the last dose of zimberelimab or pembrolizumab, or 6 months after the last dose of pemetrexed, whichever is longer
- Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy
- Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer
- Prior use of an adenosine pathway targeting agent
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 |
|---|---|---|
| EtrumadenantAlso: AB928Etrumadenant is an A2aR and A2bR antagonist | Drug | Dose Escalation Arm A, Dose Escalation Arm B, Dose Expansion Arm 2 |
| ZimberelimabAlso: AB122Zimberelimab is a fully human anti-PD-1 monoclonal antibody | Drug | Dose Expansion Arm 1, Dose Expansion Arm 2 |
| CarboplatinCarboplatin administered as part of standard chemotherapy regimen | Drug | Dose Escalation Arm A, Dose Escalation Arm B, Dose Expansion Arm 1, Dose Expansion Arm 2 |
| PemetrexedPemetrexed administered as part of standard chemotherapy regimen | Drug | Dose Escalation Arm A, Dose Escalation Arm B, Dose Expansion Arm 1, Dose Expansion Arm 2 |
| PembrolizumabPembrolizumab is a humanized anti-PD-1 monoclonal antibody | Drug | Dose Escalation Arm B |
Primary outcome
Percentage of participants with Adverse Events
Time frame: From first study treatment administration until up to 90 days after the last dose (Approximately 1 year)
Percentage of participants who experience a Dose Limiting Toxicity
Time frame: From first study treatment administration through Day 21
7 secondary outcomes
Percentage of participants with anti-drug antibodies to zimberelimab
Time frame: Recorded at baseline (screening), during the first 4 cycles of treatment (4 months) and 30 days post last dose (i.e. in total approximately 5 months).
Plasma concentration of etrumadenant
Time frame: Recorded at baseline (screening), during the first 4 cycles of treatment (4 months) and 30 days post last dose (i.e. in total approximately 5 months).
Serum concentration of zimberelimab
Time frame: Recorded at baseline (screening), during the first 4 cycles of treatment (4 months) and 30 days post last dose (i.e. in total approximately 5 months).
Progression Free Survival (PFS)
Time frame: From start of treatment up to the first occurrence of progressive disease or death from any cause, whichever occurs first (up to approximately 3-5 years)
Duration of Response
Time frame: From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
Percentage of Participants with Disease Control (complete response, partial response, or stable disease) for >6 months
Time frame: From study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years)
Percentage of participants with Objective Response
Time frame: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 3-5 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- ARC-4 - Public websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.
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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.
Medical Director study director
Arcus Biosciences, Inc.
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Etrumadenant, Zimberelimab and Carboplatin in people with Non Small Cell Lung Cancer Metastatic and Non Small Cell Lung Cancer, run by Arcus Biosciences, Inc. at 22 sites in 4 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 19 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: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, South Korea, Taiwan, Singapore. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of participants with Adverse Events (time frame: From first study treatment administration until up to 90 days after the last dose (Approximately 1 year)). The study lists 2 primary outcomes in all. 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 9 Dec 2024.