Non-small Cell Lung Cancer MetastaticPhase 1/2SPRINGNCT03386929

Survival Prolongation by Rationale Innovative Genomics

A Phase 1/2 study testing Avelumab, Axitinib and Palbociclib in people with Non-small Cell Lung Cancer Metastatic and Non-small Cell Lung Cancer Stage IIIB, run by Worldwide Innovative Network Association at 5 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Patients with advanced/metastatic non-small cell lung cancer (NSCLC) with no documented targetable alterations (Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) translocation, ROS1 mutation if available or MET exon 14 skipping mutation if available) will receive a tri-therapy… 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 Stage IIIB
What is being tested?: Avelumab, Axitinib and Palbociclib
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 5 sitesin 4 countries
Study dates: 29 Nov 2017to 29 Dec 2022
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

None listed.

Who cannot join

Patients with documented oncogenic aberrations at enrollment: EGFR, ALK, ROS1 when available, MET exon 14 skipping when available. For squamous undifferentiated cell carcinoma, documentation of these aberrations is not mandatory. Note: For Phase 1 portion, all patients with adenocarcinoma histology must have documentation of results for druggable oncogenic aberrations (EGFR mutations, ALK rearrangements, and ROS1 when available) prior to enrollment on the study.
For Phase 1 portion, >2 lines of prior therapy in the metastatic setting.
For the dose escalation phase of the study or until the MTD for the combination regimen has been determined, patients with moderate hepatic impairment defined as AST, ALT, alkaline phosphatase (ALP) >5 times ULN, which would be grade 3 or higher. However, patients with liver metastases with AST/ALT ≤ 5 x ULN can be included in the study.
For Phase 2 portion, any prior therapy in the metastatic setting.
Clinical criteria for phase 1 and phase 2 studies:
Patients with treated brain metastases are eligible as are patients with new, active untreated brain metastasis.

Show all 38Show fewer

Participants with a history of myocardial infarction within the last 2 years or with significant cardiac arrhythmias uncontrolled by medication or pacemaker,
Participants with any history of interstitial lung disease,
Prior clinically significant toxicities from anticancer agents or radiotherapy which have not regressed to Grade ≤ 1 severity (NCI-CTCAE version 4.03) apart from peripheral neuropathy and alopecia,
History of any second malignancy in the last two years; patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease-free for at least two years,
Autoimmune condition requiring medical intervention,
Uncontrolled concomitant illness, active infection requiring i.v. antibiotics,
Patients who have had a thromboembolic event within six months are excluded, as are patients on anticoagulants, except for low dose aspirin (<100 mg/day) and low doses of anticoagulants meant to keep line access open;
Patients with Grade 3 or 4 (serious) gastrointestinal bleeding within the last six months are excluded.
Prior > G3 hemoptysis, major blood vessel involvement (specifically including aorta, superior and inferior vena cave, main pulmonary arteries and veins, subclavian arteries and veins and other large blood vessels that in the investigator's opinion places the patients at high risk for major bleeding), and/or central cavitations,
Known or suspected drug hypersensitivity to any drug used in the combination,
Difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the oral drugs,
Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc.) that, in the judgment of the investigator may affect the patient's ability to sign the informed consent and undergo study procedures,
Taking another experimental drug within 28 days prior to day 1 of the protocol medications in this study,
Pregnant or breast-feeding women,
Both male and female patients of reproductive potential must agree to use highly effective contraception, during the study and for 3 months following the last dose of study drug,
Patients currently taking strong CYP3A4 inducers and inhibitors,
Patients currently taking proton pump inhibitors due to their impact on the disposition of palbociclib during the phase 1.
Patients taking other anticancer agents with the exception of denosumab or equivalent medication for bone metastases.
A time period of at least three weeks (including radiotherapy) or five drug half-lives, whichever is shorter must have elapsed from last non-investigational therapy before first day of treatment on this study,
A time period of at least 10 days must have elapsed from last palliative radiotherapy before the first day of treatment on this study,
Specific exclusion criteria for administration of avelumab, in combination:
IMMUNOSUPRESSANTS: Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
AUTOIMMUNE DISEASE: Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
ORGAN TRANSPLANTATION: Prior organ transplantation including allogenic stem-cell transplantation.
INFECTIONS: Active infection requiring IV (Intra venous) therapy.
HIV/AIDS: Known history of testing positive for HIV or known acquired immunodeficiency syndrome.
HEPATITIS: Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive).
VACCINATION: Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines.
HYPERSENSITIVITY TO STUDY DRUG: Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3).
CARDIOVASCULAR DISEASE: Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia inadequately controlled by medication.
OTHER PERSISTING TOXICITIES: Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Trial locations and contacts

5 sites in 4 countries.

Country

City, postcode or hospital

5 sites in 4 countries

United States2 sites

UCSD Moores Cancer Center
La Jolla, California, 92093
Avera Cancer Center
Sioux Falls, South Dakota, 57105

Other trials in United States

Israel1 site

Chaim Sheba Medical Center
Ramat Gan, 5265601

Other trials in Israel

Luxembourg1 site

Centre Hospitalier Luxembourg
Luxembourg, 1210

Other trials in Luxembourg

Spain1 site

Vall Hebron Institute of Oncology
Barcelona, 08035

Other trials in Spain

About this study

Official title: A Proof of Concept Study to Explore Safety and Efficacy of Tri-therapy Approach in Advanced/Metastatic NSCLC and Retrospectively Assess the Ability of Integrated Genomics and Transcriptomics to Match Patients to the Combination

Read the detailed description

During the Phase 1 (approximately 30 patients), the tri-therapy will be tested at different doses following a specific dose-escalation scheme (3 + 3 model) in order to establish the safety and identify the Maximum Tolerated Dose (MTD) and recommended dose for the Phase 2 (RP2D). The phase 2 will confirm the safety and will assess the clinical utility of the tri-therapy approach in the treatment of advanced/metastatic NSCLC (100 patients). The study will also explore the clinical utility of the Simplified Interventional Mapping System (SIMS), a new tool/algorithm enabling matching of NSCLC patients with combination therapy. For this purpose tumor/metastasis and matched normal tissue biopsies will be requested in order to obtain sequencing and expression profiles.

Conditions: Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage IIIB
Being tested: Avelumab, Axitinib, Palbociclib
Keywords: NSCLC, tri-therapy, avelumab, axitinib, palbociclib, dual matched normal and tumor biopsies, SIMS algorithm, Sequencing, Gene expression
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.

AvelumabDrug
A human antibody of the immunoglobulin gamma-1 isotype that specifically targets and blocks the Programmed Death ligand (PD-L1) for PD-1.
AxitinibDrug
Also called Inlyta
A selective oral (tablet) inhibitor of tyrosine kinases Vascular Endothelial Growth Factor (VEGF) receptors 1, 2, and 3. These receptors are implicated in pathologic angiogenesis, tumor growth and cancer progression.
PalbociclibDrug
Also called Ibrance
A selective, reversible oral (capsule) inhibitor of cyclin-dependent kinases (CDK) 4 and 6. The inhibition of CDK 4/6 blocks DNA synthesis by prohibiting progression of the cell cycle from G1 to S phase.

Study groups in NCT03386929
Study group	Role	What they receive
Avelumab, Axitinib, Palbociclib	Experimental	For the Phase 1: Avelumab is administered intravenously (IV) on Day 1 and Day 15 of a 28 day cycle in combination with axitinib po bid (every day of a 28 day cycle) and palbociclib po (on days 8-28 of a 28 day cycle). For the Phase 2: Avelumab, axitinib and palbociclib are administered at the recommended phase 2 dose (RP2D) as determined during the phase 1 part of the study. Receives: Drug: Avelumab; Drug: Axitinib; Drug: Palbociclib

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of the Tested 3-Drug Combination Therapy-Emergent Adverse Events and Serious Adverse Events
The occurrence of adverse events and serious adverse events reported from the signing of an informed consent through 90 days after the last administration of the treatment will be summarized for all subjects who received at least one dose of the study treatment (safety population) and will be evaluated based on NCI CTCAE v4.03: June 14, 2010.
Measured: From informed consent signature through 90 days after administration of the treatment (last dose)
Response Rate (RR)
Response rate is defined as the proportion of participants with reduction in tumor burden of a predefined amount based on RECIST 1.1 evaluation
Measured: Baseline up to approximately 24 months
Duration of the Response
Duration of Response (DR) is defined for patients with confirmed objective response (Complete Response [CR] or Partial Response [PR]) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Measured: Baseline up to approximately 24 months
Progression-Free Survival (PFS)
Progression Free Survival (PFS) is defined as the time from the first dose of study treatment to the date of disease progression by RECIST 1.1 or death due to any cause, whichever occurs first.
Measured: Baseline up to approximately 24 months
Overall Survival (OS)
OS is defined as the time from the first dose of study treatment to the date of death due to any cause.
Measured: Baseline up to approximately 24 months
SIMS Algorithm to Predict Clinical Outcome
The proportion of participants whose SIMS analysis matches the treatment combination, will be correlated retrospectively to clinical outcome.
Measured: 4 years

Secondary outcomes (2)

Incidence of Treatment-related and or Biopsy-related Serious Adverse Events
The occurrence of treatment-related and or biopsy-related serious adverse events as assessed by NCI CTCAE v4.03 will be summarized for all study subjects.
Measured: 4 years
Genomic and Transcriptomic Profile
Genomic (DNA) and transcriptomic (RNA) aberrations (mutations, translocations, rearrangements and changes in expression level) identified in the study population (Non-Small Cell Lung) will be described.
Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Nov 201729 Dec 2022

First posted29 Dec 2017
Study start29 Nov 2017
Primary completion29 Dec 2022
Study completion29 Dec 2022

Why it stopped: The SPRING trial had to be early terminated at the end of the Phase 1 portion of the study due to the absence of funding necessary for the performance of the Phase 2.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03386929
Sponsor's protocol ID: WIN001
Other IDs: 2017-001455-32, 2017
Acronym: SPRING
Status last verified: Nov 2023
First submitted: 14 Dec 2017
Last updated: 18 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Solomon B, Callejo A, Bar J, Berchem G, Bazhenova L, Saintigny P, Wunder F, Raynaud J, Girard N, Lee JJ, Sulaiman R, Prouse B, Bresson C, Ventura H, Magidi S, Rubin E, Young B, Onn A, Leyland-Jones B, Schilsky RL, Lazar V, Felip E, Kurzrock R. A WIN Consortium phase I study exploring avelumab, palbociclib, and axitinib in advanced non-small cell lung cancer. Cancer Med. 2022 Jul;11(14):2790-2800. doi: 10.1002/cam4.4635. Epub 2022 Mar 20.
PubMed 35307972

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Proof of Concept Study to Explore Safety and Efficacy of Tri-therapy Approach in Advanced/Metastatic NSCLC and Retrospectively Assess the Ability of Integrated Genomics and Transcriptomics to Match Patients to the Combination
ClinicalTrials.gov ID: NCT03386929
Acronym / sponsor ID: SPRING / WIN001
Conditions: Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage IIIB
Keywords: NSCLC, tri-therapy, avelumab, axitinib, palbociclib, dual matched normal and tumor biopsies, SIMS algorithm, Sequencing
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The SPRING trial had to be early terminated at the end of the Phase 1 portion of the study due to the absence of funding necessary for the performance of the Phase 2.
Enrolment: 15 participants (actual)
Lead sponsor: Worldwide Innovative Network AssociationUniversity, hospital or other
Collaborators: ARC Foundation for Cancer Research, Pfizer
Study start: 29 Nov 2017 (actual)
Primary completion: 29 Dec 2022 (actual)
Study completion: 29 Dec 2022 (actual)
First posted: 29 Dec 2017 (actual)
Results: Posted 18 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Avelumab, Axitinib, Palbociclib	Experimental	Drug: Avelumab, Drug: Axitinib, Drug: PalbociclibFor the Phase 1: Avelumab is administered intravenously (IV) on Day 1 and Day 15 of a 28 day cycle in combination with axitinib po bid (every day of a 28 day cycle) and palbociclib po (on days 8-28 of a 28 day cycle). For the Phase 2: Avelumab, axitinib and palbociclib are administered at the recommended phase 2 dose (RP2D) as determined during the phase 1 part of the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (38 listed)

Patients with documented oncogenic aberrations at enrollment: EGFR, ALK, ROS1 when available, MET exon 14 skipping when available. For squamous undifferentiated cell carcinoma, documentation of these aberrations is not mandatory. Note: For Phase 1 portion, all patients with adenocarcinoma histology must have documentation of results for druggable oncogenic aberrations (EGFR mutations, ALK rearrangements, and ROS1 when available) prior to enrollment on the study.
For Phase 1 portion, >2 lines of prior therapy in the metastatic setting.
For the dose escalation phase of the study or until the MTD for the combination regimen has been determined, patients with moderate hepatic impairment defined as AST, ALT, alkaline phosphatase (ALP) >5 times ULN, which would be grade 3 or higher. However, patients with liver metastases with AST/ALT ≤ 5 x ULN can be included in the study.
For Phase 2 portion, any prior therapy in the metastatic setting.
Patients with treated brain metastases are eligible as are patients with new, active untreated brain metastasis.

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
AvelumabA human antibody of the immunoglobulin gamma-1 isotype that specifically targets and blocks the Programmed Death ligand (PD-L1) for PD-1.	Drug	Avelumab, Axitinib, Palbociclib
AxitinibAlso: InlytaA selective oral (tablet) inhibitor of tyrosine kinases Vascular Endothelial Growth Factor (VEGF) receptors 1, 2, and 3. These receptors are implicated in pathologic angiogenesis, tumor growth and cancer progression.	Drug	Avelumab, Axitinib, Palbociclib
PalbociclibAlso: IbranceA selective, reversible oral (capsule) inhibitor of cyclin-dependent kinases (CDK) 4 and 6. The inhibition of CDK 4/6 blocks DNA synthesis by prohibiting progression of the cell cycle from G1 to S phase.	Drug	Avelumab, Axitinib, Palbociclib

Primary outcome

Incidence of the Tested 3-Drug Combination Therapy-Emergent Adverse Events and Serious Adverse Events
Time frame: From informed consent signature through 90 days after administration of the treatment (last dose)
The occurrence of adverse events and serious adverse events reported from the signing of an informed consent through 90 days after the last administration of the treatment will be summarized for all subjects who received at least one dose of the study treatment (safety population) and will be evaluated based on NCI CTCAE v4.03: June 14, 2010.
Response Rate (RR)
Time frame: Baseline up to approximately 24 months
Response rate is defined as the proportion of participants with reduction in tumor burden of a predefined amount based on RECIST 1.1 evaluation
Duration of the Response
Time frame: Baseline up to approximately 24 months
Duration of Response (DR) is defined for patients with confirmed objective response (Complete Response [CR] or Partial Response [PR]) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Progression-Free Survival (PFS)
Time frame: Baseline up to approximately 24 months
Progression Free Survival (PFS) is defined as the time from the first dose of study treatment to the date of disease progression by RECIST 1.1 or death due to any cause, whichever occurs first.
Overall Survival (OS)
Time frame: Baseline up to approximately 24 months
OS is defined as the time from the first dose of study treatment to the date of death due to any cause.
SIMS Algorithm to Predict Clinical Outcome
Time frame: 4 years
The proportion of participants whose SIMS analysis matches the treatment combination, will be correlated retrospectively to clinical outcome.

2 secondary outcomes

Incidence of Treatment-related and or Biopsy-related Serious Adverse Events
Time frame: 4 years
Genomic and Transcriptomic Profile
Time frame: 4 years

Results and safety

Results posted to the registry on 18 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Level 1	6	0
Dose Level 2	6	0
Dose Level 3	3	0

Primary outcome: Incidence of the Tested 3-Drug Combination Therapy-Emergent Adverse Events and Serious Adverse Events

Time frame: From informed consent signature through 90 days after administration of the treatment (last dose)

Population analysed: This outcome could not be measured because the data were not collected. Indeed, the trial was early terminated after the end of the phase 1. The phase 2 was not started, no data can be reported.

Primary outcome: Response Rate (RR)

Time frame: Baseline up to approximately 24 months

Primary outcome: Duration of the Response

Time frame: Baseline up to approximately 24 months

Primary outcome: Progression-Free Survival (PFS)

Time frame: Baseline up to approximately 24 months

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose Level 1	3 of 6 (50%)	6 of 6 (100%)	2 of 6
Dose Level 2	4 of 6 (66.7%)	6 of 6 (100%)	1 of 6
Dose Level 3	2 of 3 (66.7%)	3 of 3 (100%)	1 of 3

Limitations and caveats (from the sponsor): The trial was early terminated after the end of its Phase 1 due to lack of funding. As a result it was not possible to analyse the objectives of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35307972Solomon B, Callejo A, Bar J, Berchem G, Bazhenova L, Saintigny P, Wunder F, Raynaud J, Girard N, Lee JJ, Sulaiman R, Prouse B, Bresson C, Ventura H, Magidi S, Rubin E, Young B, Onn A, Leyland-Jones B, Schilsky RL, Lazar V, Felip E, Kurzrock R. A WIN Consortium phase I study exploring avelumab, palbociclib, and axitinib in advanced non-small cell lung cancer. Cancer Med. 2022 Jul;11(14):2790-2800. doi: 10.1002/cam4.4635. Epub 2022 Mar 20.
sponsor websiteLink provided by the sponsor.
Link to the publication of the results of the Phase 1 part of the studyLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

RAZELLE KURZROCK, MD principal investigator

Medical College of Wisconsin, Milwaukee, WI, USA

5 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 0 inclusion and 38 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: stopped early, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Israel, Luxembourg, Spain. 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 combined 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.

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?

Yes. Results are posted in the registry (first posted 18 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Incidence of the Tested 3-Drug Combination Therapy-Emergent Adverse Events and Serious Adverse Events (time frame: From informed consent signature through 90 days after administration of the treatment (last dose)). The study lists 6 primary outcomes in all. 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 NCT03386929, 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 18 Dec 2023.