West Cancer Center

LUNG: Metastatic; Squamous; FGFR1 amplified; Phase 1; Any line: "117360"

Multi-arm, non-randomized, open-label phase IB study to evaluate GSK3052230 in combination with pacliatxel and carboplatin, or docetaxel or as single agent in subjects with solid malignancies and deregulated FGF pathway signaling

Title

GlaxoSmithKline 117360

Study Title

Site Link

NCT01868022

Malignancy

Lung, squamous NSCLC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st line (Arm A)>_2nd line (Arm B)

Investigational Agent

GSK3052230

Drug Class

FGFR-1 Fc Fusion Protein

Daruka Mahadevan, MD, PhD

Sponsor

GlaxoSmithKline

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

https://www.clinicaltrials.gov/ct2/show/study/NCT01868022

Key Eligibility Criteria Details

Stage IV recurrent metastatic squamous NSCLC with FGFR1 gene amplification by central lab testing
Arm A- 1st line
Arm B- 2nd or later line
Measurable disease
ECOG PS 0-1 (Arm A) or 0-2 (Arm B)
No biologic x6 weeks prior, no anti-cancer tx x4 weeks prior
No bulky abdominal disease
No symptomatic CNS dz. Stable asymptomatic CNS dz x4 weeks allowed
No recent hemoptysis (>1/2 tsp red blood)

Objective

Primary- Adverse events; DLTs; BOR; ORR. Secondary- PFS; PK

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

SquamousFGFR1 gene amplification

Dosing Frequency

Arm A- GSK3052230+ Carboplatin and Paclitaxel Arm B- GSK3052230+docetaxel

Control Agents

Study Protocol

Randomized