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

Symphogen

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Squamous Non-Small Cell Lung Cancer

Treatments: Drug: Nivolumab; Drug: Sym004

Study type: Interventional

Funder types: Industry

Identifiers

NCT02924233

Sym004-10

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 3 patient groups

Sym004 + nivolumab

Experimental group

Description:

Phase 1b, dose-escalation: Dose Level 1: Sym004 + nivolumab (Q2W) Dose Level 2: Sym004 + nivolumab (Q2W) Dose Level -1: Sym004 + nivolumab, if needed

Treatment:

Drug: Sym004

Drug: Nivolumab

Sym004 (RP2D) + nivolumab

Experimental group

Description:

Phase 2b, dose-expansion: Receiving Sym004 in the RP2D in combination with nivolumab (Q2W)

Treatment:

Drug: Sym004

Drug: Nivolumab

Nivolumab

Active Comparator group

Description:

Phase 2b, dose-expansion: Receiving nivolumab monotherapy (Q2W)

Treatment:

Drug: Nivolumab