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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/NCT03974022
Registration number
NCT03974022
Ethics application status
Date submitted
21/05/2019
Date registered
4/06/2019
Date last updated
16/05/2024
Titles & IDs
Public title
Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)
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Scientific title
A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With EGFR or HER2 Mutation
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Secondary ID [1]
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DZ2019E0001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Sunvozertinib
Experimental: Part A Dose escalation -
Experimental: Part A Dose expansion cohort 1 -
Experimental: Part A Dose expansion cohort 2 -
Experimental: Part A Dose expansion cohort 3 - Patients with EGFR Exon20ins, previously treated with at least one line of systemic therapy
Experimental: Part A Dose expansion cohort 4 - Patients with EGFR Exon20ins, previously treated with at least one line of systemic therapy
Experimental: Part A Dose expansion cohort 5 - Patients with EGFR Exon20ins, treatment naïve
Experimental: Part A Dose expansion cohort 6 -
Experimental: Part B Dose extension cohort 1 - Patients with EGFR Exon20ins
Experimental: Part B Dose extension cohort 2 - Patients with EGFR Exon20ins
Treatment: Drugs: Sunvozertinib
Daily dose of Sunvozertinib
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part A: Safety and tolerability of Sunvozertinib.
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Assessment method [1]
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To investigate the safety and tolerability of Sunvozertinib when given orally to patients with advanced NSCLC with EGFR or HER2 mutations; To establish Maximum Tolerated Dose (MTD) (if possible) and Recommended Phase 2 Dose (PR2D) of Sunvozertinib when given orally in patients with advanced NSCLC with EGFR or HER2 mutations.
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Timepoint [1]
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28 days after the first multiple dose
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Primary outcome [2]
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Part B: Objective Response Rate (ORR) according to RECIST 1.1 by an Independent Review Committee (IRC).
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Assessment method [2]
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To evaluate anti-tumor activity of Sunvozertinib in advanced NSCLC patients with EGFR Exon20 insertion at defined dose(s) by assessment of Objective Response Rate (ORR).
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Timepoint [2]
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through the study completion, an average of around 1 year
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Secondary outcome [1]
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Part A: Plasma and urine Sunvozertinib concentrations, and derived PK parameters.
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Assessment method [1]
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To characterize the pharmacokinetics (PK) of Sunvozertinib following a single oral dosing and at steady state after multiple oral dosing in the fasted state, and renal excretion of Sunvozertinib.
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Timepoint [1]
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Through cycle 3 day 1 (8 days for Cycle 0, 28 days for Cycle 1, then 21 days for each subsequent cycle)
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Secondary outcome [2]
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Part A: Plasma Sunvozertinib concentrations, and derived PK parameters
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Assessment method [2]
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To evaluate the effect of food on the exposure of Sunvozertinib at the defined doses.
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Timepoint [2]
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Through the study completion
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Secondary outcome [3]
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Part A: ORR, BOR, DoR, DCR, %change in size of tumor lesion, PFS by investigator.
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Assessment method [3]
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To assess preliminary anti-tumor activity of Sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator.
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Timepoint [3]
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Through the study completion
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Secondary outcome [4]
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Part A: ORR, DCR, DoR by IRC.
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Assessment method [4]
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To retrospectively assess anti-tumor activity of Sunvozertinib in patients with EGFR Exon20ins according to RECIST 1.1 by an Independent Review Committee (IRC).
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Timepoint [4]
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Through the study completion
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Secondary outcome [5]
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Part B: DoR, PFS, DCR, BOR and % of change in size of tumor lesion according to RECIST 1.1 using assessments performed by an IRC; DoR, PFS, DCR, BOR and % of change in size of tumor lesion using investigators assessments accord.
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Assessment method [5]
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To assess anti-tumor efficacy of Sunvozertinib using additional endpoints.
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Timepoint [5]
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Through the study completion
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Secondary outcome [6]
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Part B: AEs/SAEs; Laboratory data; vital signs; physical examination; ECG; echocardiogram/MUGA; pulmonary function test.
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Assessment method [6]
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To determine the safety and tolerability of Sunvozertinib.
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Timepoint [6]
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Through the study completion
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Secondary outcome [7]
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Part B: Plasma Sunvozertinib and metabolite concentration and derived PK parameters if deemed appropriately.
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Assessment method [7]
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To characterize the PK of Sunvozertinib.
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Timepoint [7]
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Through the study completion
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Eligibility
Key inclusion criteria
1. Aged at least 18 years old, be able to provide a signed and dated, written informed
consent.
2. With documented histological or cytological confirmed locally advanced or metastatic
NSCLC with EGFR or HER2 mutations.
3. (ECOG) performance status 0-1.
4. Predicted life expectancy = 12 weeks
5. Patient must have measurable disease according to RECIST 1.1.
6. Patients with brain metastasis (BM) can be enrolled under the condition that BM is
previously treated and stable, neurologically asymptomatic and does not require
corticosteroid treatment.
7. Adequate organ system function.
8. Part A Dose expansion: Dose expansion cohort 5: NSCLC patients with EGFR Exon20ins,
who have not received prior systemic therapy (treatment naïve).
Part B Dose extension:
9. Patients must have histologically or cytologically confirmed locally advanced or
metastatic NSCLC with documented EGFR Exon20ins mutation in tumor tissue from a local
CLIA-certified laboratory (or equivalent) or Sponsor designated central laboratory
prior to the study entry.
10. Patients should have received at least 1 line, but no more than 3 lines of systemic
therapy for metastatic/locally advanced disease.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. For part B: Patients who have received prior treatment with Poziotinib or TAK788 or
other EGFR/HER2 exon20 insertion inhibitors should be excluded. Prior treatment with
currently approved EGFR TKIs for sensitizing or T790M resistance mutations, such as
gefitinib, erlotinib, osimertinib, afatinib and dacomitinb, are allowed unless the
patient had an objective response and subsequent progression assessed by the
investigator.
2. Treatment with EGFR or HER2 antibodies, major surgery (excluding placement of vascular
access), or onco-immunotherapy (e.g. immune checkpoint inhibitors PD-1, PD-L1, CTLA-4)
within 4 weeks before the first administration of Sunvozertinib.
3. Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a
previous treatment regimen or clinical study within 14 days before the first
administration.
4. Radiotherapy with a limited field of radiation for palliation within 1 week of the
first dose or with a wide field of radiation which must be completed within 4 weeks
before the first administration.
5. Receiving (or unable to stop using) medications or herbal supplements known to be
potent inhibitors or inducers of CYP3A within 1-2 weeks before the first
administration.
6. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of
starting Sunvozertinib with the exception of alopecia and grade 2 prior
platinum-therapy related neuropathy.
7. Spinal cord compression or leptomeningeal metastasis.
8. As judged by the investigator, any evidence of severe or uncontrolled systemic
diseases, which would jeopardize compliance with the protocol, or active infection
including hepatitis B, hepatitis C, human immunodeficiency virus (HIV) and COVID-19
(per local practice).
9. Any of the following cardiac criteria: (1) Mean resting corrected QT interval (QTc) >
470 msec obtained from 3 electrocardiograms (ECGs); (2) Any clinically significant
abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left
bundle branch block, third degree heart block, and second-degree heart block, PR
interval > 250 msec. (3) Any factors that increase the risk of QTF prolongation, such
as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT
syndrome or unexplained sudden death under 40 years of age in first degree relatives
or any concomitant medication known to prolong the QT interval; (4) Prior history of
atrial fibrillation within 6 months of first administration of Sunvozertinib, except
prior drug treatment related and recovered.
10. Past medical history of interstitial lung disease, drug-induced interstitial lung
disease, radiation pneumonitis which required steroid treatment, or any evidence of
clinically active interstitial lung disease.
11. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to
swallow the formulated product or previous significant bowel resection that would
preclude adequate absorption of Sunvozertinib.
12. History of hypersensitivity to active or inactive excipients of Sunvozertinib or drugs
with a similar chemical structure or class to Sunvozertinib.
13. Women who are pregnant or breast feeding.
14. Involvement in the planning and conduct of the study.
15. Judgment by the investigator that the patient should not participate in the study if
the patient is unlikely to comply with study procedures, restrictions and
requirements.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/07/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
315
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Blacktown Hospital - Blacktown
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Chris O'Brien Lifehouse - Camperdown
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Austin Hospital - Heidelberg
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St George Hospital - Kogarah
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Recruitment hospital [5]
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Peter MacCallum Cancer Centre - East Melbourne - North Melbourne
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Recruitment hospital [6]
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Linear Cancer trials - Perth
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Recruitment hospital [7]
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Southern Medical Day Care Centre - Wollongong
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- Blacktown
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- Camperdown
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- Heidelberg
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- Kogarah
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Recruitment postcode(s) [5]
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- North Melbourne
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Recruitment postcode(s) [6]
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- Perth
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Recruitment postcode(s) [7]
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- Wollongong
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Recruitment outside Australia
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Taoyuan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Dizal Pharmaceuticals
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Address
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Ethics approval
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Summary
Brief summary
This study will treat patients with advanced NSCLC with EGFR or HER2 mutation who have
progressed following prior therapy. This is the first time this drug is tested in patients,
and so it will help to understand what type of side effects may occur with the drug
treatment. It will also measure the levels of drug in the body and preliminarily assess its
anti-cancer activity as monotherapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03974022
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pasi Antero Jänne, M.D & Ph. D
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Dana-Farber Cancer Institute
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03974022
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