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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04035486




Registration number
NCT04035486
Ethics application status
Date submitted
27/06/2019
Date registered
29/07/2019
Date last updated
14/02/2024

Titles & IDs
Public title
A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)
Scientific title
A Phase III, Open-label, Randomized Study of Osimertinib With or Without Platinum Plus Pemetrexed Chemo, as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA2).
Secondary ID [1] 0 0
2019-000650-61
Secondary ID [2] 0 0
D5169C00001
Universal Trial Number (UTN)
Trial acronym
FLAURA2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Osimertinib
Treatment: Drugs - Pemetrexed/Carboplatin
Treatment: Drugs - Pemetrexed/Cisplatin

Active Comparator: Osimertinib 80mg QD - Osimertinib (AZD9291) 80mg QD.
All patients randomized into this will only receive Osimertinib 80mg.
Dose may be reduced to allow for the management of IP related toxicity.

Experimental: Osimertinib 80 mg QD and platinum-based chemotherapy - Osimertinib 80 mg in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.
Dose may be reduced to allow for the management of IP related toxicity.


Treatment: Drugs: Osimertinib
Drug: Osimertinib (Oral)
Other Names:
AZD9291

Treatment: Drugs: Pemetrexed/Carboplatin
Drug: Pemetrexed (500 mg/m2) plus carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.

Treatment: Drugs: Pemetrexed/Cisplatin
Drug: Pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
The primary analysis of Progression-free survival (PFS) based on investigator assessment will occur when PFS maturity is observed at approximately 33 months after the first patient is randomized.
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Overall Survival will be analyzed at 2 time points: when PFS maturity is observed at approximately 33 months after the first patient is randomized, and when OS maturity is observed at approximately 70 months after the first patient is randomized
Secondary outcome [2] 0 0
Landmark Overall Survival (LOS)
Timepoint [2] 0 0
The analysis of Landmark Overall Survival will be conducted at 2 time points: when PFS maturity is observed at approximately 33 months, and when Overall Survival maturity is observed at approximately 70 months after the first patient is randomized.
Secondary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
Objective Response Rate analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 33 months from the first patient being randomized.
Secondary outcome [4] 0 0
Duration of Response (DoR)
Timepoint [4] 0 0
Duration of Response analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 33 months from the first patient being randomized.
Secondary outcome [5] 0 0
Depth of Response
Timepoint [5] 0 0
Depth of Response analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 33 months from the first patient being randomized.
Secondary outcome [6] 0 0
Disease Control Rate (DCR) by Investigator
Timepoint [6] 0 0
Disease Control Rate analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 33 months from the first patient being randomized.
Secondary outcome [7] 0 0
Progression Free Survival 2 (PFS2)
Timepoint [7] 0 0
Progression Free Survival 2 analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 33 months from the first patient being randomized.
Secondary outcome [8] 0 0
Change from baseline and time to deterioration in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30)
Timepoint [8] 0 0
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -Core 30 items analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 33 months from the first patient being randomized.
Secondary outcome [9] 0 0
Change from baseline and time to deterioration in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items (EORTC QLQ-LC13)
Timepoint [9] 0 0
European Organization for Research & Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 33 months from the first patient being randomized
Secondary outcome [10] 0 0
Concordance of epidermal growth factor receptor mutation status between the local epidermal growth factor receptor mutation test and the central cobas® epidermal growth factor receptor Mutation Test v2 results from tumor samples with evaluable results
Timepoint [10] 0 0
Analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 33 months from the first patient being randomized.
Secondary outcome [11] 0 0
Progression-free survival (PFS) by Investigator by plasma epidermal growth factor receptor mutation status.
Timepoint [11] 0 0
Analysis will occur when Progression-free survival (PFS)maturity is observed at approximately 33 months from the first patient being randomized.
Secondary outcome [12] 0 0
Plasma concentration of osimertinib when given with or without chemotherapy
Timepoint [12] 0 0
Plasma concentration analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 33 months from the first patient being randomized.
Secondary outcome [13] 0 0
Plasma concentration of metabolite AZ5104 when osimertinib is given with or without chemotherapy
Timepoint [13] 0 0
Plasma concentration analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 33 months from the first patient being randomized.

Eligibility
Key inclusion criteria
1. Male or female, at least 18 years of age; patients from Japan at least 20 years of
age.

2. Pathologically confirmed non-squamous Non-Small Cell Lung Cancer (NSCLC). NSCLC of
mixed histology is allowed.

3. Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic Non-Small
Cell Lung Cancer (NSCLC) (clinical stage IVA or IVB) or recurrent Non-Small Cell Lung
Cancer (NSCLC) not amenable to curative surgery or radiotherapy.

4. The tumor harbors 1 of the 2 common epidermal growth factor receptor (EGFR) mutations
known to be associated with Epidermal growth factor receptor tyrosine kinase
inhibitors (EGFR-TKI) sensitivity (Ex19del or L858R), either alone or in combination
with other epidermal growth factor receptor (EGFR) mutations, which may include T790M.

5. Patients must have untreated advanced Non-Small Cell Lung Cancer (NSCLC) not amenable
to curative surgery or radiotherapy.

6. WHO PS of 0 to 1 at screening with no clinically significant deterioration in the
previous 2 weeks.

7. Life expectancy >12 weeks at Day 1.

8. Willing to use contraception as appropriate during the study and for a period of time
after discontinuing study treatment.
Minimum age
18 Years
Maximum age
110 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Spinal cord compression; and unstable brain metastases, with stable brain metastases
who have completed definitive therapy, are not on steroids, and have a stable
neurological status for at least 2 weeks after completion of the definitive therapy
and steroids can be enrolled. Patients with asymptomatic brain metastases can be
eligible for inclusion if in the opinion of the Investigator immediate definitive
treatment is not indicated

2. Past medical history of Interstitial Lung Disease (ILD), drug-induced Interstitial
Lung Disease, radiation pneumonitis that required steroid treatment, or any evidence
of clinically active Interstitial Lung Disease.

3. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled
hypertension and active bleeding diatheses, which in the Investigator's opinion makes
it undesirable for the patient to participate in the trial or which would jeopardize
compliance with the protocol, or active infection including Hep. B, Hep. C and HIV.
Screening for chronic conditions is not required. Active infection will include any
patients receiving treatment for infection.

4. QT prolongation or any clinically important abnormalities in rhythm.

5. Inadequate bone marrow reserve or organ function as demonstrated by any of the
following laboratory values:

- Absolute neutrophil count below the lower limit of normal (<LLN)

- Platelet count below the LLN

- Hemoglobin <90 g/L. The use of granulocyte colony stimulating factor support,
platelet transfusion and blood transfusions to meet these criteria is not
permitted.

- ALT >2.5 x the upper limit of normal (ULN) if no demonstrable liver metastases or
>5 x ULN in the presence of liver metastases

- AST >2.5 x ULN if no demonstrable liver metastases or >5 x ULN in the presence of
liver metastases

- Total bilirubin >1.5 x ULN if no liver metastases or >3 x ULN in the presence of
documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver
metastases

- Creatinine clearance <60 mL/min calculated by Cockcroft and Gault equation or 24
hour urine collection (refer to Appendix I for appropriate calculation)

6. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to
swallow the formulated product, or previous significant bowel resection that would
preclude adequate absorption of osimertinib.

7. Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell Lung
Cancer (NSCLC) not amenable to curative surgery or radiation including chemotherapy,
biologic therapy, immunotherapy, or any investigational drug. Prior adjuvant and
neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy,
investigational agents), or definitive radiation/chemoradiation with or without
regimens including immunotherapy, biologic therapies, investigational agents are
permitted as long as treatment was completed at least 12 months prior to the
development of recurrent disease.

8. Prior treatment with an Epidermal growth factor receptor tyrosine kinase inhibitors
(EGFR-TKI).

9. Major surgery within 4 weeks of the first dose of investigational product (IP).
Procedures such as placement of vascular access, biopsy via mediastinoscopy or biopsy
via video assisted thoracoscopic surgery are permitted.

10. Radiotherapy treatment to more than 30% of the bone marrow or( with a wide field of
radiation within 4 weeks of the first dose of investigational product (IP).

11. History of hypersensitivity to active or inactive excipients of investigational
product (IP) or drugs with a similar chemical structure or class to investigational
product (IP).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/06/2026
Actual
Sample size
Target
Accrual to date
Final
587
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Chermside
Recruitment hospital [3] 0 0
Research Site - Elizabeth Vale
Recruitment hospital [4] 0 0
Research Site - Heidelberg
Recruitment hospital [5] 0 0
Research Site - Kogarah
Recruitment hospital [6] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
2217 - Kogarah
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
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United States of America
State/province [4] 0 0
Kentucky
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United States of America
State/province [5] 0 0
Massachusetts
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United States of America
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Nevada
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
State/province [14] 0 0
Caba
Country [15] 0 0
Argentina
State/province [15] 0 0
Ciudad de Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Cordoba
Country [17] 0 0
Argentina
State/province [17] 0 0
Santa Fe
Country [18] 0 0
Brazil
State/province [18] 0 0
Barretos
Country [19] 0 0
Brazil
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Florianópolis
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Brazil
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Londrina
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Brazil
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Porto Alegre
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Brazil
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Ribeirão Preto
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Brazil
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Sao Paulo
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Brazil
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São José do Rio Preto
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Brazil
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São Paulo
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Brazil
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Vitoria
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Canada
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Alberta
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Canada
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Ontario
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Chile
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Santiago
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Chile
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Temuco
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Chile
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Viña del Mar
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China
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Beijing
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China
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Changchun
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China
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Changsha
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China
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Chengdu
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China
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Chongqing
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China
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Guangzhou
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China
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Haikou
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China
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Hangzhou
Country [40] 0 0
China
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Harbin
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China
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Hefei
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China
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Jinan
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China
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Nanjing
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China
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Shanghai
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China
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Shenyang
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China
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Urumqi
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China
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Wuhan
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China
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Xi'an
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China
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Zhengzhou
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Czechia
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Olomouc
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Czechia
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Ostrava - Vitkovice
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Czechia
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Praha 5
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Czechia
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Praha
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France
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Bordeaux Cedex
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France
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Lyon
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France
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Montpellier
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France
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Villejuif Cedex
Country [58] 0 0
India
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Belagavi
Country [59] 0 0
India
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Bengaluru
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India
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Gurgaon
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India
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Kolkata
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India
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New Delhi
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India
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Pune
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Japan
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Bunkyo-ku
Country [65] 0 0
Japan
State/province [65] 0 0
Fukuoka
Country [66] 0 0
Japan
State/province [66] 0 0
Hidaka-shi
Country [67] 0 0
Japan
State/province [67] 0 0
Himeji-shi
Country [68] 0 0
Japan
State/province [68] 0 0
Iwakuni-shi
Country [69] 0 0
Japan
State/province [69] 0 0
Kanazawa
Country [70] 0 0
Japan
State/province [70] 0 0
Kashiwa
Country [71] 0 0
Japan
State/province [71] 0 0
Koto-ku
Country [72] 0 0
Japan
State/province [72] 0 0
Osaka-shi
Country [73] 0 0
Japan
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Sakai-shi
Country [74] 0 0
Japan
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Sapporo-shi
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Japan
State/province [75] 0 0
Sendai-shi
Country [76] 0 0
Japan
State/province [76] 0 0
Sunto-gun
Country [77] 0 0
Japan
State/province [77] 0 0
Yokohama-shi
Country [78] 0 0
Korea, Republic of
State/province [78] 0 0
Cheongju-si
Country [79] 0 0
Korea, Republic of
State/province [79] 0 0
Goyang-si
Country [80] 0 0
Korea, Republic of
State/province [80] 0 0
Seoul
Country [81] 0 0
Peru
State/province [81] 0 0
Arequipa
Country [82] 0 0
Peru
State/province [82] 0 0
Lima
Country [83] 0 0
Peru
State/province [83] 0 0
San Isidro
Country [84] 0 0
Philippines
State/province [84] 0 0
Cebu City
Country [85] 0 0
Philippines
State/province [85] 0 0
Davao City
Country [86] 0 0
Philippines
State/province [86] 0 0
Iloilo City
Country [87] 0 0
Philippines
State/province [87] 0 0
Las Pinas
Country [88] 0 0
Philippines
State/province [88] 0 0
Legazpi City
Country [89] 0 0
Philippines
State/province [89] 0 0
Quezon City
Country [90] 0 0
Russian Federation
State/province [90] 0 0
Moscow
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Murmansk
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Saint Petersburg
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Saint-Petersburg
Country [94] 0 0
Russian Federation
State/province [94] 0 0
Syktyvkar
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Slovakia
State/province [95] 0 0
Bratislava
Country [96] 0 0
Slovakia
State/province [96] 0 0
Kosice
Country [97] 0 0
Slovakia
State/province [97] 0 0
Poprad
Country [98] 0 0
South Africa
State/province [98] 0 0
Johannesburg
Country [99] 0 0
South Africa
State/province [99] 0 0
Port Elizabeth
Country [100] 0 0
South Africa
State/province [100] 0 0
Rondebosch
Country [101] 0 0
Taiwan
State/province [101] 0 0
Changhua
Country [102] 0 0
Taiwan
State/province [102] 0 0
Hualien City
Country [103] 0 0
Taiwan
State/province [103] 0 0
Kaohsiung City
Country [104] 0 0
Taiwan
State/province [104] 0 0
Taichung
Country [105] 0 0
Taiwan
State/province [105] 0 0
Taipei
Country [106] 0 0
Thailand
State/province [106] 0 0
Bangkok
Country [107] 0 0
Thailand
State/province [107] 0 0
Hat Yai
Country [108] 0 0
Thailand
State/province [108] 0 0
Khon Kaen
Country [109] 0 0
Thailand
State/province [109] 0 0
Muang
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Cambridge
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Leicester
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Liverpool
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Maidstone
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Manchester
Country [115] 0 0
Vietnam
State/province [115] 0 0
Hanoi
Country [116] 0 0
Vietnam
State/province [116] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The reason for the study is to find out if an experimental combination of an oral medication
called osimertinib (TAGRISSO®) when used in combination with chemotherapy is more effective
than giving osimertinib alone for the treatment of locally advanced or metastatic non-small
cell lung cancer. Some lung cancers are due to mutations in the Deoxyribonucleic acid (DNA)
which, if known, can help physicians decide the best treatment for their patients. One type
of mutation can occur in the gene that produces a protein on the surface of cells called the
Epidermal Growth Factor Receptor (EGFR).

Osimertinib is an Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI)
that targets Epidermal Growth Factor Receptor (EGFR) mutations. Unfortunately, despite the
benefit observed for patients treated with osimertinib, the vast majority of cancers are
expected to develop resistance to the drug over time. The exact reasons why resistance
develops are not fully understood but based upon clinical research it is hoped that combining
osimertinib with another type of anti-cancer therapy known as chemotherapy will delay the
onset of resistance and the worsening of a patient's cancer.

In total the study aims to enroll approximately 586 patients, consisting of approximately 30
patients who will participate in a safety run-in component of the trial, and approximately
556 who will receive osimertinib alone or osimertinib in combination with chemotherapy in the
main trial. In the main part of the trial there is a one in two chance of receiving
osimertinib alone, and the treatment is decided at random by a computer.

The study involves a Screening Period, Treatment Period, and Follow up Period. Whilst
receiving study medication, it is expected patients will attend, on average, approximately 15
visits over the first 12 months and then approximately 4 visits per year afterwards. Each
visit will last about 2 to 6 hours depending on the arrangement of medical assessments by the
study centre.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04035486
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pasi A. Jänne, MD
Address 0 0
Dana Farber Cancer Institute, 450 Brookline Avenue, LC4114, Boston, MA 02215, USA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04035486