Sym004 in Subjects With Stage IV Non-small Cell Lung Cancer

Merck KGaA (EMD Serono)

Status and phase: Terminated; Phase 1

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel; 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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02083679

EMR200637-003

2013-003995-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 4 patient groups

Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine

Experimental group

Treatment:

Drug: Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine

Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed

Experimental group

Treatment:

Drug: Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed

Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel

Experimental group

Treatment:

Drug: Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel

Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel

Experimental group

Treatment:

Drug: Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel