Sym004 in Combination With Nivolumab Versus Nivolumab Monotherapy in EGFR-amplified Squamous Non-Small Cell Lung Cancer

• Status: Withdrawn
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1b/2b study investigating the safety and preliminary antitumor effects of Sym004 in combination with nivolumab versus nivolumab monotherapy when administered every second week.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Symphogen A/S
• Treatments: Antibodies, Monoclonal; Nivolumab

Criteria

Main Inclusion Criteria:

• Signed and dated written informed consent

• Male or female ≥18 years of age at the time of informed consent

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Life expectancy >3 months assessed during Screening

• Histologically or cytologically confirmed, locally advanced or metastatic squamous NSCLC

Main Exclusion Criteria:

• Any antineoplastic agent (standard or investigational) within 2 weeks prior to starting trial treatment

• Radiosurgery or radiotherapy for target lesions within 2 weeks prior to starting trial treatment

• Prophylactic use of hematopoietic growth factors within 1 week prior to starting trial treatment

• Active Central Nervous System (CNS) metastases or carcinomatous meningitis

• Women who are pregnant

• Women who are breastfeeding