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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083679
• Other study ID #: EMR200637-003
• Secondary ID: 2013-003995-11
• Status: Completed
• Phase: Phase 1
• First received: March 7, 2014
• Last updated: November 9, 2015
• Start date: May 2014
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Institutional Ethical CommitteeItaly: Ethics CommitteeItaly: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Sym004 plus Platinum-Doublet Chemotherapy
Sym004 will be administered as an intravenous infusion at a dose range of 6 to 18 milligram per kilogram (mg/kg) as defined in the protocol until unacceptable toxicity, progressive disease, or withdrawal of consent in combination with 1 of the 3 platinum-doublet chemotherapy regimens as intravenous infusion: cisplatin/gemcitabine (cisplatin on Day 1 plus gemcitabine on Days 1 and 8, every 3 weeks), cisplatin/pemetrexed (cisplatin plus pemetrexed on Day 1, every 3 weeks), or carboplatin/paclitaxel (carboplatin plus paclitaxel on Day 1, every 3 weeks). Platinum-doublet chemotherapy will continue for a maximum of 6 treatment cycles.

Locations

Country	Name	City	State
Germany	Please contact the Merck KGaA Communication Center located in	Darmstadt
United States	Please Contact U.S. Medical Information Located in	Rockland	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
EMD Serono

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with Dose Limiting Toxicities (DLTs)		Up to Day 22 of Cycle 1	Yes
Secondary	Number of subjects with adverse events (AEs), serious AEs (SAEs), treatment-emergent adverse events (TEAEs), AEs leading to discontinuation and AEs leading to death		Time from first intake of study drug up to 28 days after the last dose administration	Yes