Lung-MAP: Rilotumumab and Erlotinib Hydrochloride or Erlotinib Hydrochloride Alone as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and Positive Biomarker Matches

Conditions

• MET Positive
• Recurrent Squamous Cell Lung Carcinoma
• Stage IV Squamous Cell Lung Carcinoma AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Erlotinib Hydrochloride — DRUG
  Given PO
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Rilotumumab — BIOLOGICAL
  Given IV

Study Details

This randomized phase II/III compares rilotumumab when given together with erlotinib hydrochloride against erlotinib hydrochloride alone in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a sub-study that includes all screened patients positive for the met proto-oncogene (MET)/hepatocyte growth factor (HGF) biomarker. HGF can interact with MET and can cause tumor cells to grow more quickly. Rilotumumab may decrease the activity of HGF and may be able to shrink tumors. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving rilotumumab with erlotinib hydrochloride works better than erlotinib hydrochloride alone (standard treatment) in treating squamous cell lung cancer.

Key Dates

First listed

Oct 6, 2016

Start date

Jun 16, 2014

Status verified

Mar 2020

Primary completion

Jan 12, 2015

Completion

Oct 12, 2016

Study Design

Enrollment

9 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (rilotumumab, erlotinib)
  Patients receive rilotumumab IV over 60-120 minutes on day 1 and erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AND INTERVENTION 11/25/2014)
• Active Comparator: Arm II (erlotinib)
  Patients receive erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AND INTERVENTION 11/25/2014)

Primary Outcome Measure

Investigator-assessed Progression-free Survival Between Arms [ Time Frame: From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 18 months since completion of accrual ]

Locations (627)

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