Sym004 in Subjects With Stage IV Non-small Cell Lung Cancer
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 25, 2016 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- EMD Serono
- Interventions being studied
- Drug: Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine; Drug: Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed; Drug: Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel; Drug: Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Please Contact U.S. Medical Information Located inRockland, Massachusetts
- Please contact the Merck KGaA Communication Center located inDarmstadt
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 25, 2016. Always confirm current availability with the study team.