Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007248

Trial Description

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Title

A Phase Ib, Open-label, Dose Escalation Trial Investigating Different Doses and Schedules of Sym004 in Combination With Platinum-doublets in Subjects With Stage IV Non-small Cell Lung Cancer

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This is a multi-center, open-label, Phase 1b, dose escalation trial of Sym004 administered
in combination with 1 of 3 platinum-doublets in subjects with Stage IV Non-Small Cell Lung
Cancer (NSCLC).

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007248
  •   2015/04/24
  •   2014/03/07
  •   no
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Secondary IDs

  •   2013-003995-11 
  •   NCT02083679  (ClinicalTrials.gov)
  •   EMR200637-003  (EMD Serono)
  •   2013-003995-11 
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Health Condition or Problem studied

  •   Carcinoma, Non-Small-Cell Lung
  •   C34.9 -  Malignant neoplasm: Bronchus or lung, unspecified
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Interventions/Observational Groups

  •   Drug: Sym004 plus Platinum-Doublet Chemotherapy
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I
  •   [---]*
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Primary Outcome

- Number of Dose Limiting Toxicities (DLTs) as determined in Part-1; time frame: Up to Day 22 of Cycle 1
- Relative Dose Intensity (RDI) as determined in Part-2; time frame: Up to 30 months

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Secondary Outcome

- Best overall response rate; time frame: Week 6 and thereafter every 6 weeks, up to 30 months
- Progression free survival (PFS) time; time frame: Time from first intake of study drug until the date of objectively documented disease progression or death due to any cause, assessed up to 30 months
- Overall survival (OS) time; time frame: Time from first intake of study drug until death due to any cause, assessed up to 30 months
- Changes from Baseline in tumor size at End of Sym004 treatment (up to Month 30); time frame: Baseline, End of Sym004 treatment (up to Month 30)
- Relative Dose Intensity (RDI) of each Sym004 dose level as determined in Part-1; time frame: Up to 30 months
- Change from Baseline in anti-drug antibody (ADA) levels at End of Sym004 treatment (up to Month 30); time frame: Baseline, End of Sym004 treatment (up to Month 30)
- Epidermal growth factor receptor (EGFR) levels in archived tumor tissue; time frame: Day 1
- Biomarkers level in blood and archived tissue related to the EGFR pathway; time frame: Day 1
- Pharmacokinetics parameters: AUC (0-168 hours), Cmax, tmax, C(trough), t1/2, CL, and Vd; time frame: Baseline, End of Sym004 treatment (up to Month 30)
- Number of subjects with treatment-emergent adverse events (TEAEs); time frame: Time from first intake of study drug up to 28 days after the last dose administration

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Countries of Recruitment

  •   United States
  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2014/05/31
  •   89
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Male or female outpatients (except where inpatient stay is required for medical need
at the Investigator's discretion) at least 18 years of age at the time of informed
consent

- Histologically-confirmed NSCLC Stage IV disease (according to the seventh edition of
the lung cancer staging system)

- Eligibility for platinum-based chemotherapy

- Tumor tissue available for EGFR expression analysis

- Measurable disease defined as 1 or more target lesions according to Response
Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)

- Life expectancy of at least 3 months

- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1

- Other protocol defined inclusion criteria could apply

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Exclusion Criteria

- Previous therapy for Stage IV NSCLC, or neo- or adjuvant chemotherapy or
chemoradiotherapy within the previous 6 months

- Previous investigational drug or any anticancer therapy in the 30 days (or 5
half-lives for non-cytotoxics, whichever is shorter) prior to the start of trial
treatment

- In countries where anaplastic lymphoma kinase (ALK) inhibitors are available for the
treatment of NSCLC, subjects need to have been screened for ALK fusion gene
rearrangements and excluded if positive, unless previously treated and progressed on
an appropriate tyrosine kinase inhibitor (TKI) therapy

- In countries where EGFR TKIs are available for the treatment of NSCLC, subjects need
to have been screened for EGFR mutations and excluded if positive, unless previously
treated and progressed on an appropriate TKI therapy

- Concurrent chronic immunosuppressive or hormone anticancer therapy (except other
physiologic hormone replacement)

- Known brain metastases (unless asymptomatic and treated) or leptomeningeal
metastases, including suspected leptomeningeal spread with positive cytology

- History of any other malignancy within 5 years (except basal cell carcinoma of the
skin or carcinoma in situ of the cervix)

- Other protocol defined exclusion criteria could apply

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Addresses

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    • EMD Serono
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    • Merck KGaA
    • Medical Responsible 
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    •   [---]*
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    • US Medical Information 
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    •   888-275-7376
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.