Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)

Conditions

• Lung Cancer
• Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

20 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Patritumab — DRUG
  Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks)
• Erlotinib — DRUG
  Oral erlotinib 150 mg/day
• Placebo — DRUG
  Placebo infusion every 3 weeks

Study Details

1. Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2 (Human Epidermal Growth Factor Receptor 2), anti-HER3, or anti-HER4 therapy. Subjects may have high heregulin or low heregulin. 2. Part B: Subjects will receive Patritumab or placebo with erlotinib. Overall survival will be the primary outcome. Subjects will need to have EGFR wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy. Only subjects with high heregulin will be enrolled.

Key Dates

First listed

May 8, 2014

Start date

Mar 31, 2014

Status verified

Dec 2017

Primary completion

Nov 11, 2016

Completion

Nov 11, 2016

Study Design

Enrollment

145 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Placebo + erlotinib
  Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
• Experimental: Patritumab + erlotinib
  Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day

Primary Outcome Measure

Part A: Progression Free Survival (PFS) in Heregulin-high Participants [ Time Frame: by trial termination (at 20 months) ]

Locations (26)

Find similar trials in Glendale, AZ

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