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

Squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02924233
• Other study ID #: Sym004-10
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: September 28, 2016
• Last updated: August 25, 2017
• Start date: November 2016
• Est. completion date: February 2017

Study information

• Verified date: August 2017
• Source: Symphogen A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• Sym004
Sym004 is a 1:1 mixture of two monoclonal antibodies (mAbs) which bind to two non-overlapping epitopes of the Epidermal Growth Factor Receptor (EGFR). Sym004 will be administered at different dose-levels via infusion Q2W
• Nivolumab
Nivolumab is a humanized immunoglobulin G4 (IgG4) anti-PD-1 monoclonal antibody. Nivolumab will be administered via 60-minute infusion Q2W

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Symphogen A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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