Clinical trial NCT02083679: Sym004 in Subjects With Stage IV Non-small Cell Lung Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Carcinoma, Non-Small-Cell Lung
Sym004
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2014-03-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

The sponsor decided to discontinue the development of Sym004. Also the decision was made to discontinue the development of Sym004 in NSCLC indication. The decision to discontinue Sym004 in NSCLC was not related to any safety or efficacy findings regarding Sym004. As a result of the early discontinuation of the trial during the dose escalation part, the expansion cohort will no longer be performed hence the pre-specified secondary endpoints are not analyzed and were removed from the protocol based on protocol amendment 2 dated 31 March 2015.


Eligibility criteria: 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 epidermal growth factor receptor (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

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

Primary outcomes:
measure: Number of Subjects With Dose Limiting Toxicities (DLTs)
timeFrame: Day 1 to Day 21 of Cycle 1
Secondary outcomes:
measure: Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
timeFrame: Day 1 up to 28 days after last dose of study drug (up to 53 weeks)
Other outcomes:
Locations:
city: Rockland
country: United States
facility: Please Contact U.S. Medical Information Located in
state: Massachusetts
city: Darmstadt
country: Germany
facility: Please contact the Merck KGaA Communication Center located in
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: