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

Recruiting in Palo Alto (17 mi)

+626 other locations

Overseen byVassiliki Papadimitrakopoulou

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Southwest Oncology Group

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Vassiliki Papadimitrakopoulou

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

Inclusion Criteria

Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)

Analyte: C-MET

Assay: Immunohistochemistry (IHC)

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Treatment Details

Interventions

Erlotinib Hydrochloride (Tyrosine Kinase Inhibitor)
Rilotumumab (Monoclonal Antibodies)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (rilotumumab, erlotinib)Experimental Treatment3 Interventions

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)

Group II: Arm II (erlotinib)Active Control2 Interventions

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)