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

Status

Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02924233

Enrollment

Registered

2016-10-05

Start date

2016-11-30

Completion date

2017-02-28

Last updated

2017-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Non-Small Cell Lung Cancer

Keywords

Squamous, Non-Small Cell Lung Cancer, NSCLC

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.

Interventions

DRUGSym004

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

DRUGNivolumab

Nivolumab is a humanized immunoglobulin G4 (IgG4) anti-PD-1 monoclonal antibody. Nivolumab will be administered via 60-minute infusion Q2W

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026