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

An Open-label, Randomized, Multicenter, Phase 1b/2b Trial Investigating the Safety and Preliminary Antitumor Effects of Sym004 in Combination With Nivolumab Versus Nivolumab Monotherapy in EGFR-amplified Squamous Non-Small Cell Lung Cancer

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.

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