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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedErlotinib Hydrochloride and Laboratory Biomarker Analysis

Plus 1 other study approaches.

Who it may be forMET · Metastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 19, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2 / Phase 3

Interventional

Where is it offered?627 U.S. locations

Locations may change over time.

Who runs it?SWOG Cancer Research Network

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2 / Phase 3
Sponsor: SWOG Cancer Research Network
Interventions being studied: Drug: Erlotinib Hydrochloride; Other: Laboratory Biomarker Analysis; Biological: Rilotumumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Metastatic or stage IV→Recurrent or relapsed→

Biomarkers

MET→

Study topics

After prior treatment→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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)
Patients must be assigned to S1400E; S1400E biomarker eligibility defined as C-MET positive is defined as follows:
Analyte: C-MET
Assay: Immunohistochemistry (IHC)
Eligible definition: IHC positive based on Dako MET-IHC pharm DX kit
If randomized to arm I rilotumumab plus erlotinib, patients must be willing to provide blood specimens for anti-rilotumumab anti-body testing
Patients must not have peripheral edema \> grade 1 at the time of sub-study registration
Patients must not have received prior treatment with MET pathway, inhibitors or EGFR inhibitors (e.g., erlotinib)
Patients must have total bilirubin =\< 1.5 x institutional upper limits of normal (IULN) within 28 days prior to sub-study registration
Patients must not have abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjorgren?s syndrome), congenital abnormality (e.g., Fuch?s dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or abnormal corneal sensitivity test (Schirmer test or similar tear production test)
Patients must not be taking, nor plan to take while on protocol treatment and for 14 days post the last dose of study treatment, drugs, herbal supplements or foods that are known to be strong/moderate CYP3A4 substrates

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Fowler Family Center for Cancer CareJonesboro, Arkansas
University of Arkansas for Medical SciencesLittle Rock, Arkansas
Kaiser Permanente-AnaheimAnaheim, California
Kaiser Permanente-Deer Valley Medical CenterAntioch, California
Sutter Auburn Faith HospitalAuburn, California
Kaiser Permanente-Baldwin ParkBaldwin Park, California
Kaiser Permanente-BellflowerBellflower, California
Alta Bates Summit Medical Center-Herrick CampusBerkeley, California
Mills-Peninsula Medical CenterBurlingame, California
Sutter Davis HospitalDavis, California
City of Hope Comprehensive Cancer CenterDuarte, California
Kaiser Permanente HospitalFontana, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 19, 2020. Always confirm current availability with the study team.

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