U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer

A Multicenter, Open-Label Phase 1 Study of U3-1402 in Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer

This study is designed to evaluate safety and antitumor activity of U3-1402 in two parts: Dose Escalation and Dose Expansion.

In Dose Escalation, U3-1402 will be evaluated in participants with metastatic or unresectable NSCLC with epidermal growth factor receptor (EGFR) activating mutation after disease progression during/after EGFR tyrosine kinase inhibitor (TKI) therapy.

In Dose Expansion, U3-1402 will be evaluated in participants with metastatic or unresectable NSCLC with EGFR activating mutation or squamous or non-squamous NSCLC (ie, without EGFR-activating mutations) with disease progression during/after systemic treatment for locally advanced or metastatic disease.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-Small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: U3-1402 (FL-DP); Drug: U3-1402 (CTM-1 Lyo-DP); Drug: U3-1402 (CTM-3 Lyo-DP)

Detailed Description

The primary objectives are:

• For Dose Escalation, to assess the safety and tolerability of U3-1402 in the study population and to determine the recommended dose for expansion (RDE) of U3-1402 in the study population
• For Dose Expansion, to investigate the antitumor activity of U3-1402

The number of treatment cycles is not fixed in this study. Participants will continue study treatment (for approximately 36 months) until they decide not to (withdraw consent), their disease gets worse [progressive disease (PD)], or side effects become unacceptable (unacceptable toxicity) or other stopping reasons have been met.

• Study Type: Interventional
• Enrollment (Actual): 271
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan, 5898511
    • Kindai University Hospital
  • Shizuoka, Japan, 4118777
    • Shizuoka Cancer Center
  • Tokyo, Japan, 1358550
    • The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JFCR)
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Netherlands Cancer Institute
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
• Taiwan
  • Taichung, Taiwan, 40705
    • Chung Shan Medical University Hospital
  • Tainan, Taiwan, 00704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 00100
    • National Taiwan University Hospital
• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope
    • La Jolla, California, United States, 92093
      • University of California San Diego
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute of Emory University
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute/Tennesse Oncology
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for both Dose Escalation and Dose Expansion:

1. Has locally advanced or metastatic NSCLC, not amenable to curative surgery or radiation
2. Has at least one measurable lesion per RECIST version 1.1
3. Has Eastern Cooperative Oncology Group performance status of 0 or 1 at Screening

Inclusion Criteria for Dose Escalation only:

1. Has histologically or cytologically documented adenocarcinoma NSCLC

2. Has acquired resistance to EGFR TKI according to the Jackman criteria (PMID: 19949011)

   1. Historical confirmation that the tumor harbors an epidermal growth factor receptor (EGFR) mutation known to be associated with EGFR tyrosine kinase inhibitor (TKI) sensitivity (including G719X, exon 19 deletion, L858R, L861Q)
   2. Has experienced clinical benefit from an EGFR TKI, followed by systemic progression of disease [Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1] or World Health Organization (WHO)] while on continuous treatment with an EGFR TKI
3. Is currently receiving and able to discontinue erlotinib, gefinitib, afatinib, or osimertinib
4. Has been receiving erlotinib, gefitinib, afatinib, or osimertinib for at least 6 weeks with well-controlled related toxicities less than Grade 3 in severity at the time of Screening
5. Has radiological documentation of disease progression while receiving continuous treatment with erlotinib, gefitinib, afatinib, or osimertinib
6. Is willing to provide archival tumor tissue from a biopsy performed within 6 months of progression during treatment with erlotinib, gefitinib, afatinib, or osimertinib OR has at least one lesion, not previously irradiated, amenable to core biopsy and is willing to undergo screening tumor biopsy
7. Demonstrates absence of EGFR T790M mutation if treated with erlotinib, gefitinib, or afatinib. No EGFR mutation testing is required if treated with osimertinib.

Inclusion Criteria for all cohorts of Dose Expansion only:

1. Has received systemic therapy for locally advanced or metastatic disease including at least 1 platinum-based chemotherapy regimen
2. Has documented radiological disease progression during/after most recent treatment regimen for locally-advanced or metastatic disease

3. For Cohorts 1, 2, 3a, and 3b: Is willing to provide archival tumor tissue from a biopsy performed within 6 months of consent and performed after progression during/after treatment with most recent cancer therapy regimen OR has at least 1 lesion, not previously irradiated, amenable to core biopsy and is willing to undergo tumor biopsy. Tumor tissue must be of sufficient quantity as defined in the laboratory manual and contain adequate tumor tissue content as confirmed by haematoxylin and eosin (H&S) staining at central laboratory.

   • For Cohort 4: Neither archival tumor tissue nor core tumor biopsy will be collected

Inclusion Criteria specific to Cohorts 1, 3a, 3b, and 4 of Dose Expansion:

1. Has histologically or cytologically documented:

   1. Cohort 1: Adenocarcinoma NSCLC
   2. Cohorts 3a, 3b, and 4: NSCLC (including any histology other than small-cell or combined small cell and non-small cell)
2. Has documentation of radiological disease progression following one or more lines of EGFR TKI treatment. Participants with EGFR T790M mutation following treatment with erlotinib, gefitinib afatinib, or dacomitinib must have received and have documentation of radiological disease progression following treatment with osimertinib unless unable or unwilling.
3. Has documentation of EGFR-activating mutation(s) detected from tumor tissue: G719X, exon deletion 19, L858R, or L861Q. Participants with other EGFR-activating mutations may be eligible following discussion with the Sponsor.

Inclusion Criteria specific to Cohort 2 of Dose Expansion:

1. Has histologically or cytologically documented squamous or non-squamous NSCLC (ie, without EGFR-activating mutations).
2. Has received prior treatment with anti-PD-1 or anti-PD-L1 antibody-based regimen in the locally advanced or metastatic setting unless unable or unwilling. Participants with NSCLC known to harbor a genomic alteration(s) other than EGFR mutation(s) (eg, ALK or ROS1 fusion) for which treatment is available must have also received prior treatment with at least 1 genotype-directed therapy.

Exclusion Criteria for Dose Escalation and Dose Expansion:

1. Has any evidence of small cell histology, or combined small cell and non-small cell histology, in original tumor biopsy or in Screening biopsy performed after progression

2. Treatment with any of the following:

   1. Any cytotoxic chemotherapy, investigational agent or other anticancer drug(s) from a previous cancer treatment regimen or clinical study (other than EGFR TKI in Cohorts 1, 3a, 3b, and 4 only), within 14 days of the first dose of study treatment
   2. Immune checkpoint inhibitor therapy within 21 days of the first dose of study treatment
   3. Prior treatment with an anti-HER3 antibody (dose escalation only)
   4. Prior treatment with a topoisomerase I inhibitor (dose escalation only)
   5. Prior treatment with an antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, DS-8201a) (dose escalation only)
   6. Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug treatment
   7. 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 study drug treatment, or palliative radiation therapy within 2 weeks of the first dose of study drug treatment, or stereotactic radiotherapy within 1 week prior to the first dose of U3-1402

3. Has history of other active malignancy within 3 years prior to enrollment, except:

   1. Adequately treated non-melanoma skin cancer OR
   2. Superficial bladder tumors (Ta, Tis, T1) OR
   3. Curatively treated in situ disease
4. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment (1 week for stereotactic radiotherapy)
5. Has history of myocardial infarction within the past 6 months
6. Has symptomatic congestive heart failure[New York Heart Association (NYHA) Classes II-IV], unstable angina within the past 6 months, or cardiac arrhythmia requiring antiarrhythmic treatment
7. Has left ventricular ejection fraction (LVEF) < 50% by either echocardiogram (ECHO) or multigated acquisition scan (MUGA)
8. Has any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG), eg, complete left bundle branch block, third-degree heart block, second-degree heart block, or PR interval > 250 milliseconds (ms)
9. Has a mean corrected QT interval using Fridericia's Correction Formula (QTcF) prolongation to > 470 ms for females and > 450 ms for males in three successive Screening measurements
10. Unable or unwilling to discontinue concomitant drugs that are known to prolong the QT interval
11. Has any factors that increase the risk of corrected QT (QTc) interval prolongation or risk of arrhythmic events, such as congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.
12. Has any history of interstitial lung disease (ILD) (including pulmonary fibrosis or severe radiation pneumonitis), has current ILD/pneumonitis, or is suspected to have such disease by imaging during screening
13. Has clinically significant corneal disease

Additional Exclusion Criteria for Dose Expansion Cohort 2:

1. Has documentation of one or more of the following EGFR-activating mutations: G719X, exon 19 deletion, L858R, or L861Q

Additional Exclusion Criteria for Dose Expansion Cohort 4:

1. Evidence of any leptomeningeal disease

2. Clinically severe respiratory compromise (based on Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to:

   1. Any underlying pulmonary disorder
   2. Any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement OR prior complete pneumonectomy
3. Is receiving chronic systemic corticosteroids dosed at >10 mg/day prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to enrollment
4. Resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg
5. Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that could affect the safety of the subject; alter the absorption, distribution, metabolism or excretion of the study drug; or confound the assessment of study results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation: Cohort 1, 3.2 mg/kg; Participants in the Dose Escalation Cohort 1 will receive U3-1402 intravenously (IV) once every three weeks at 3.2 mg/kg.	Drug: U3-1402 (FL-DP); U3-1402 (frozen liquid drug product) consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a).
Experimental: Dose Escalation: Cohort 2, 4.8 mg/kg; Participants in Dose Escalation Cohort 2 will receive U3-1402 intravenously (IV) once every three weeks at 4.8 mg/kg.	Drug: U3-1402 (FL-DP); U3-1402 (frozen liquid drug product) consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a).
Experimental: Dose Escalation: Cohort 3, 5.6 mg/kg; Participants in Dose Escalation Cohort 3 will receive U3-1402 intravenously (IV) once every three weeks at 5.6 mg/kg.	Drug: U3-1402 (FL-DP); U3-1402 (frozen liquid drug product) consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a).
Experimental: Dose Escalation: Cohort 4, 6.4 mg/kg; Participants in Dose Escalation Cohort 3 will receive U3-1402 intravenously (IV) once every three weeks at 6.4 mg/kg.	Drug: U3-1402 (FL-DP); U3-1402 (frozen liquid drug product) consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a).
Experimental: Dose Expansion: Cohort 1, EGFR mutant; Participants with adenocarcinoma NSCLC with EGFR mutations in the Dose Expansion Cohort 1 will receive U3-1402 IV once every three weeks at the established recommended dose for expansion (RDE).	Drug: U3-1402 (CTM-1 Lyo-DP); U3-1402 (lyophilized drug product) consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a) that was manufactured by the clinical manufacturing sites.
Experimental: Dose Expansion: Cohort 2, EGFR wild-type; Participants with squamous or non-squamous NSCLC without EGFR-activating mutations in the Dose Expansion Cohort 2 will receive U3-1402 IV once every three weeks at the established recommended dose for expansion (RDE).	Drug: U3-1402 (CTM-1 Lyo-DP); U3-1402 (lyophilized drug product) consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a) that was manufactured by the clinical manufacturing sites.
Experimental: Dose Expansion: Cohort 3a, EGFR mutant; Randomized participants with NSCLC and EGFR mutations in the Dose Expansion Cohort 3a will receive U3-1402 IV once every three weeks at the established recommended dose for expansion (RDE) or, if applicable, adjusted RDE (aRDE).	Drug: U3-1402 (CTM-1 Lyo-DP); U3-1402 (lyophilized drug product) consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a) that was manufactured by the clinical manufacturing sites.
Experimental: Dose Expansion: Cohort 3b, EGFR mutant; Randomized participants with NSCLC and EGFR mutations in the Dose Expansion Cohort 3b will receive U3-1402 IV once every three weeks following an up-titration regimen (Cycle 1, Day 1: 57% of RDE or aRDE; Cycle 2, Day 1: 86% of RDE or, if applicable aRDE; Cycle 3 and subsequent cycles, Day 1: 114% of RDE or aRDE).	Drug: U3-1402 (CTM-1 Lyo-DP); U3-1402 (lyophilized drug product) consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a) that was manufactured by the clinical manufacturing sites.
Experimental: Dose Expansion: Cohort 4, EGFR mutant; Participants with NSCLC (including any histology other than small-cell or combined small-cell and non-small cell) with an EGFR-activating mutation will receive U3-1402 IV at 5.6 mg/kg every 3 weeks.	Drug: U3-1402 (CTM-3 Lyo-DP); U3-1402 (lyophilized drug product) consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a) that was manufactured by the commercial manufacturing sites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-limiting toxicities (DLTs) during dose escalation		21 days of Cycle 1
Summary of adverse events during dose escalation		By the global end of trial date, approximately within 36 months
Overall response rate (ORR) assessed by Blinded Independent Central Review (BICR) Committee during dose expansion	ORR will be evaluated using RECIST v1.1.	Approximately within 36 months
Maximum serum concentration (Cmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion (Cohort 4)		Cycle 1: Day 1, pre-dose and end of infusion (EOI), 2 hours, 4 hours, 8 hours; Day 8, Day 15; Cycle 2: Day 1, pre-dose (each cycle is 21 days)
Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) and up to last quantifiable time (AUC[last]) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion (Cohort 4)		Cycle 1: Day 1, pre-dose and end of infusion (EOI), 2 hours, 4 hours, 8 hours; Day 8, Day 15; Cycle 2: Day 1, pre-dose (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum serum concentration (Cmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation		During approximately the first 84 days after dosing
Time of maximum concentration (Tmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation		During approximately the first 84 days after dosing
Area under the serum concentration-time curve from time 0 to 8 hours (AUC[0-8]) and up to last quantifiable time (AUC[last]) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation		During approximately the first 84 days after dosing
Terminal elimination rate constant (Kel) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation		During approximately the first 84 days after dosing
Elimination half-life (t1/2) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation		During approximately the first 84 days after dosing
Total body clearance (CL) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation		During approximately the first 84 days after dosing
Volume of distribution after a single-dose (Vz) and at steady-state after multiple doses (Vss) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation		During approximately the first 84 days after dosing
Overall response rate (ORR) during dose escalation	Evaluated using RECIST 1.1	Approximately within 36 months
Disease control rate (DCR) during dose escalation		Approximately within 36 months
Duration of response (DOR) during dose escalation		Approximately within 36 months
Time to response (TTR) during dose escalation		Approximately within 36 months
Progression free survival (PFS) during dose escalation		Approximately within 36 months
Overall Survival (OS) during dose escalation		Approximately within 36 months
Summary of adverse events during dose expansion		By the global end of trial date, approximately within 36 months
Maximum serum concentration (Cmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion		During approximately the first 84 days after dosing
Time of maximum concentration (Tmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion		During approximately the first 84 days after dosing
Area under the serum concentration-time curve from time 0 to 8 hours (AUC[0-8]), from time 0 to Day 21 (AUC-21d), and up to last quantifiable time (AUC[last]) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion		During approximately the first 84 days after dosing
Terminal elimination rate constant (Kel) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion		During approximately the first 84 days after dosing
Elimination half-life (t1/2) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion		During approximately the first 84 days after dosing
Total body clearance (CL) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion		During approximately the first 84 days after dosing
Volume of distribution after a single-dose (Vz) and at steady-state after multiple doses (Vss) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion		During approximately the first 84 days after dosing
Overall response rate (ORR) during dose expansion	Evaluated using RECIST 1.1	Approximately within 36 months
Disease control rate (DCR) during dose expansion		Approximately within 36 months
Duration of response (DOR) during dose expansion		Approximately within 36 months
Time to response (TTR) during dose expansion		Approximately within 36 months
Progression free survival (PFS) during dose expansion		Approximately within 36 months
Overall survival (OS) during dose expansion		Approximately within 36 months
Percentage of participants who are anti-drug antibody (ADA)-positive (baseline and post-baseline) and Percentage of participants who have treatment-emergent ADA during dose expansion (Cohort 4)		Approximately within 36 months

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.
• Investigators: Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.

Publications and helpful links

General Publications

• Jackman D, Pao W, Riely GJ, Engelman JA, Kris MG, Janne PA, Lynch T, Johnson BE, Miller VA. Clinical definition of acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancer. J Clin Oncol. 2010 Jan 10;28(2):357-60. doi: 10.1200/JCO.2009.24.7049. Epub 2009 Nov 30.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Actual): January 28, 2022
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: August 22, 2017
• First Posted (Actual): August 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: EGFR; Metastatic; Unresectable; Oncology; Epidermal growth factor receptor; Advanced Non-small Cell Lung Cancer; Inoperable Non-small Cell Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Antineoplastic Agents, Immunological; Patritumab deruxtecan
• Other Study ID Numbers: U31402-A-U102; 2017-000543-41 (EudraCT Number); 194868 (Other Identifier: JapicCTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No