ResectablePhase 2NCT03794544
Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer
A Phase 2 study testing Durvalumab, Oleclumab and Monalizumab in people with Resectable and Early-stage, run by MedImmune LLC at 18 sites in 7 countries.
Trial summary
Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of neoadjuvant durvalumab alone or in combination with novel agents in participants with resectable, early-stage (Stage I [>2cm] to IIIA) non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 102 years
- Conditions the study is for
- Resectable, Early-stage, NSCLC
- What is being tested?
- Durvalumab, Oleclumab and Monalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 18 sitesin 7 countries
- Study dates
- 8 Mar 2019to 13 Jan 2021
- Phase
- Phase 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 to 102 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cytologically and/or histologically-documented NSCLC
- Stage I (> 2 cm) to IIIA (for participants with N2 disease, only those with 1 single nodal station ≤ 3 cm are eligible) NSCLC according to the 8th edition of American Joint Committee on Cancer staging classification
- Amenable to complete surgical resection
- Have not received any other therapy for this condition
- Predicted forced expiratory volume in one second (FEV1) ≥ 50%
- Predicted diffusing capacity of the lungs for carbon monoxide (DLCO) ≥ 50%
- ECOG 0 or 1
- Adequate organ function
Who cannot join
- Participants with small-cell lung cancer or mixed small-cell lung cancer
- Participants who require or may require pneumonectomy
- Prior treatment with programmed cell death ligand-1 (PD-L1), PD-L1, or cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitors
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug.
- Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion:
- Participants with vitiligo or alopecia
Show all 20Show fewer
- Participants with hypothyroidism on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Participants without active disease in the last 5 years may be included but only after consultation with the study physician
- Participants with celiac disease controlled by diet alone
- Pregnant or breast-feeding female
- Major surgical procedure within prior 30 days
- History of active primary immunodeficiency
- Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV
- QTc interval (QTc) ≥ 470 ms
- Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent
- Receipt of live attenuated vaccination within 30 days prior to study entry
- History of another primary malignancy except for:
- Curative-treated malignancy with no known active disease > 2 years before enrollment on the study
- Curative-treated non-melanoma skin cancer and/or carcinoma in-situ
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
United States10 sites
Research Site
Baltimore, Maryland, 21231
Research Site
Buffalo, New York, 14263
Research Site
Chattanooga, Tennessee, 37404
Research Site
Fairfax, Virginia, 22031
Research Site
Fort Myers, Florida, 33901
Research Site
Houston, Texas, 77030
Research Site
La Jolla, California, 92093
Research Site
Leesburg, Florida, 34748
Research Site
Nashville, Tennessee, 37203
Research Site
New York, New York, 10016
About this study
Official title: A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Subjects With Resectable, Early-stage (I [> 2 cm] to IIIA) Non-small Cell Lung Cancer (NeoCOAST)
Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of neoadjuvant durvalumab alone or in combination with novel agents in participants with resectable, early-stage (Stage I [>2cm] to IIIA) non-small cell lung cancer (NSCLC).
- Conditions
- Resectable, Early-stage, NSCLC
- Being tested
- Durvalumab, Oleclumab, Monalizumab, Danvatirsen
- Keywords
- Neoadjuvant, Non-small Cell Lung Cancer, Cancer, Lung, Resectable, Early-stage, Stage I, Stage II, Stage IIIA, Durvalumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called MEDI4736
Durvalumab 1500 mg IV will be administered Q4W (on Week 1 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.
OleclumabCombination product
Also called MEDI9447
Oleclumab 3000 mg IV will be administered Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.
MonalizumabCombination product
Also called IPH2201
Monalizumab 750 mg IV will be administered Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.
DanvatirsenCombination product
Also called AZD9150
Danvatirsen 200 mg IV will be administered on Days 1, 3, and 5 of Week 0 (7-day danvatirsen lead-in period) and later every week (on Week 1 Day 1, Week 2 Day 1, Week 3 Day 1, and Week 4 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab 1500 mg | Experimental | Participants will receive durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W; on Week 1 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection will be planned between Day 29 and Day 42. After surgical resection, participants will be followed up to Day 105 (starting from Week 1 Day 1). Receives: Drug: Durvalumab |
| Durvalumab 1500 mg + Oleclumab 3000 mg | Experimental | Participants will receive durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and oleclumab 3000 mg IV every 2 weeks (Q2W; on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection will be planned between Day 29 and Day 42. After surgical resection, participants will be followed up to Day 105 (starting from Week 1 Day 1). Receives: Drug: Durvalumab; Combination Product: Oleclumab |
| Durvalumab 1500 mg + Monalizumab 750 mg | Experimental | Participants will receive durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and monalizumab 750 mg IV Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection will be planned between Day 29 and Day 42. After surgical resection, participants will be followed up to Day 105 (starting from Week 1 Day 1). Receives: Drug: Durvalumab; Combination Product: Monalizumab |
| Durvalumab 1500 mg + Danvatirsen 200 mg | Experimental | Participants will receive danvatirsen 200 mg IV on Days 1, 3, and 5 of Week 0 (7-day danvatirsen lead-in period), followed by durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and danvatirsen 200 mg IV every week (on Week 1 Day 1, Week 2 Day 1, Week 3 Day 1, and Week 4 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection will be planned between Day 29 and Day 42. After surgical resection, participants will be followed up to Day 105 (starting from Week 1 Day 1). Receives: Drug: Durvalumab; Combination Product: Danvatirsen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response Rate
Major pathological response rate is defined as percentage of participants with <=10% residual viable tumor cells in the resected specimen.
Measured: Day 1 through Day 42
Secondary outcomes (5)
Pathological Complete Response (pCR) Rate
The pCR rate is defined as percentage of participants with no residual viable tumor cells in the resected specimen.
Measured: Day 1 through Day 42
Feasibility to Surgery
Feasibility to surgery is defined as the percentage of participants who underwent the planned surgery within Days 29 to 42 after Week 1 Day 1.
Measured: Day 29 to Day 42 after Week 1 Day 1
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Measured: From Day 1 through Day 105
Number of Participants With Grade 3 or Grade 4 Clinical Laboratory Toxicities
Participants with Grade 3 or Grade 4 clinical laboratory toxicities are reported. Laboratory tests included hematology, coagulation, chemistry, and urinalysis.
Measured: From Day 1 through Day 105
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Participants with abnormal vital sign reported as TEAEs are reported.
Measured: From Day 1 through Day 105
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start8 Mar 2019
- Primary completion13 Jan 2021
- Study completion13 Jan 2021
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 ResectableStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be enrolled and randomized into a durvalumab monotherapy arm or into a durvalumab plus other novel therapy arms. Up to approximately 25 sites globally will participate in this study. New treatment arms may be added in the future. Participants will be treated with a single durvalumab dose alone or in combination with other agents. After the single cycle treatment period participants will have the standard surgical resection planned. All participants will have a post-resection monitoring visit. Study treatment will be discontinued upon disease progression, unacceptable toxicity, or other investigators' reasons.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794544
- Sponsor's protocol ID
- D9108C00002
- Status last verified
- Feb 2022
- First submitted
- 10 Dec 2018
- Last updated
- 24 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Publications
Cascone T, Kar G, Spicer JD, Garcia-Campelo R, Weder W, Daniel DB, Spigel DR, Hussein M, Mazieres J, Oliveira J, Yau EH, Spira AI, Anagnostou V, Mager R, Hamid O, Cheng LY, Zheng Y, Blando J, Tan TH, Surace M, Rodriguez-Canales J, Gopalakrishnan V, Sellman BR, Grenga I, Soo-Hoo Y, Kumar R, McGrath L, Forde PM. Neoadjuvant Durvalumab Alone or Combined with Novel Immuno-Oncology Agents in Resectable Lung Cancer: The Phase II NeoCOAST Platform Trial. Cancer Discov. 2023 Nov 1;13(11):2394-2411. doi: 10.1158/2159-8290.CD-23-0436.
PubMed 37707791
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Subjects With Resectable, Early-stage (I [> 2 cm] to IIIA) Non-small Cell Lung Cancer (NeoCOAST)
- ClinicalTrials.gov ID
- NCT03794544
- Acronym / sponsor ID
- D9108C00002
- Conditions
- Resectable, Early-stage, NSCLC
- Keywords
- Neoadjuvant, Non-small Cell Lung Cancer, Cancer, Lung, Resectable, Early-stage, Stage I, Stage II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 7 Jan 2019 (actual)
- Results
- Posted 24 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of neoadjuvant durvalumab alone or in combination with novel agents in participants with resectable, early-stage (Stage I [>2cm] to IIIA) non-small cell lung cancer (NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be enrolled and randomized into a durvalumab monotherapy arm or into a durvalumab plus other novel therapy arms. Up to approximately 25 sites globally will participate in this study. New treatment arms may be added in the future. Participants will be treated with a single durvalumab dose alone or in combination with other agents. After the single cycle treatment period participants will have the standard surgical resection planned. All participants will have a post-resection monitoring visit. Study treatment will be discontinued upon disease progression, unacceptable toxicity, or other investigators' reasons.
| Arm | Type | Receives |
|---|---|---|
| Durvalumab 1500 mg | Experimental | Drug: DurvalumabParticipants will receive durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W; on Week 1 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection will be planned between Day 29 and Day 42. After surgical resection, participants will be followed up to Day 105 (starting from Week 1 Day 1). |
| Durvalumab 1500 mg + Oleclumab 3000 mg | Experimental | Drug: Durvalumab, Combination Product: OleclumabParticipants will receive durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and oleclumab 3000 mg IV every 2 weeks (Q2W; on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection will be planned between Day 29 and Day 42. After surgical resection, participants will be followed up to Day 105 (starting from Week 1 Day 1). |
| Durvalumab 1500 mg + Monalizumab 750 mg | Experimental | Drug: Durvalumab, Combination Product: MonalizumabParticipants will receive durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and monalizumab 750 mg IV Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection will be planned between Day 29 and Day 42. After surgical resection, participants will be followed up to Day 105 (starting from Week 1 Day 1). |
| Durvalumab 1500 mg + Danvatirsen 200 mg | Experimental | Drug: Durvalumab, Combination Product: DanvatirsenParticipants will receive danvatirsen 200 mg IV on Days 1, 3, and 5 of Week 0 (7-day danvatirsen lead-in period), followed by durvalumab 1500 mg IV Q4W (on Week 1 Day 1) and danvatirsen 200 mg IV every week (on Week 1 Day 1, Week 2 Day 1, Week 3 Day 1, and Week 4 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. Surgical resection will be planned between Day 29 and Day 42. After surgical resection, participants will be followed up to Day 105 (starting from Week 1 Day 1). |
Who may qualify
- Ages
- 18 to 102 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cytologically and/or histologically-documented NSCLC
- Predicted forced expiratory volume in one second (FEV1) ≥ 50%
- Predicted diffusing capacity of the lungs for carbon monoxide (DLCO) ≥ 50%
- ECOG 0 or 1
- Adequate organ function
Key exclusion criteria (20 listed)
- Participants with small-cell lung cancer or mixed small-cell lung cancer
- Participants who require or may require pneumonectomy
- Prior treatment with programmed cell death ligand-1 (PD-L1), PD-L1, or cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitors
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug.
- Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion:
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: MEDI4736Durvalumab 1500 mg IV will be administered Q4W (on Week 1 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. | Drug | Durvalumab 1500 mg, Durvalumab 1500 mg + Danvatirsen 200 mg, Durvalumab 1500 mg + Monalizumab 750 mg, Durvalumab 1500 mg + Oleclumab 3000 mg |
| OleclumabAlso: MEDI9447Oleclumab 3000 mg IV will be administered Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. | Combination product | Durvalumab 1500 mg + Oleclumab 3000 mg |
| MonalizumabAlso: IPH2201Monalizumab 750 mg IV will be administered Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. | Combination product | Durvalumab 1500 mg + Monalizumab 750 mg |
| DanvatirsenAlso: AZD9150Danvatirsen 200 mg IV will be administered on Days 1, 3, and 5 of Week 0 (7-day danvatirsen lead-in period) and later every week (on Week 1 Day 1, Week 2 Day 1, Week 3 Day 1, and Week 4 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period. | Combination product | Durvalumab 1500 mg + Danvatirsen 200 mg |
Primary outcome
Major Pathological Response Rate
Time frame: Day 1 through Day 42
Major pathological response rate is defined as percentage of participants with <=10% residual viable tumor cells in the resected specimen.
5 secondary outcomes
Pathological Complete Response (pCR) Rate
Time frame: Day 1 through Day 42
Feasibility to Surgery
Time frame: Day 29 to Day 42 after Week 1 Day 1
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: From Day 1 through Day 105
Number of Participants With Grade 3 or Grade 4 Clinical Laboratory Toxicities
Time frame: From Day 1 through Day 105
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Time frame: From Day 1 through Day 105
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37707791Cascone T, Kar G, Spicer JD, Garcia-Campelo R, Weder W, Daniel DB, Spigel DR, Hussein M, Mazieres J, Oliveira J, Yau EH, Spira AI, Anagnostou V, Mager R, Hamid O, Cheng LY, Zheng Y, Blando J, Tan TH, Surace M, Rodriguez-Canales J, Gopalakrishnan V, Sellman BR, Grenga I, Soo-Hoo Y, Kumar R, McGrath L, Forde PM. Neoadjuvant Durvalumab Alone or Combined with Novel Immuno-Oncology Agents in Resectable Lung Cancer: The Phase II NeoCOAST Platform Trial. Cancer Discov. 2023 Nov 1;13(11):2394-2411. doi: 10.1158/2159-8290.CD-23-0436.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink 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.
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab, Oleclumab and Monalizumab in people with Resectable and Early-stage, run by MedImmune LLC at 18 sites in 7 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 8 inclusion and 20 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 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, France, Spain, Canada, Italy and 2 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?
Yes. Results are posted in the registry (first posted 24 Feb 2022). 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?
Major Pathological Response Rate (time frame: Day 1 through Day 42). 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 NCT03794544, 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 24 Feb 2022.