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

Phase 1

Withdrawn

• Conditions: Squamous Non-Small Cell Lung Cancer
• Interventions: Drug: Sym004; Drug: Nivolumab

• Registration Number: NCT02924233
• Lead Sponsor: Symphogen A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-05
• Study Start: 2016-11
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-25
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sym004 (RP2D) + nivolumab	Sym004	Phase 2b, dose-expansion: Receiving Sym004 in the RP2D in combination with nivolumab (Q2W)
Sym004 + nivolumab	Sym004	Phase 1b, dose-escalation: Dose Level 1: Sym004 + nivolumab (Q2W) Dose Level 2: Sym004 + nivolumab (Q2W) Dose Level -1: Sym004 + nivolumab, if needed
Sym004 + nivolumab	Nivolumab	Phase 1b, dose-escalation: Dose Level 1: Sym004 + nivolumab (Q2W) Dose Level 2: Sym004 + nivolumab (Q2W) Dose Level -1: Sym004 + nivolumab, if needed
Sym004 (RP2D) + nivolumab	Nivolumab	Phase 2b, dose-expansion: Receiving Sym004 in the RP2D in combination with nivolumab (Q2W)
Nivolumab	Nivolumab	Phase 2b, dose-expansion: Receiving nivolumab monotherapy (Q2W)

Primary Outcome Measures

Name	Time	Method
Phase 1b: Determination of the Dose-Limiting Toxicities (DLT) and the MTD and/or RP2D of escalating doses of Sym004 in combination with a standard dose of nivolumab	1 year
Phase 2b: Evaluation of the antitumor effects of the RP2D of Sym004 when administered in combination with a standard dose of nivolumab as measured by Response Rate	1.5 years