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
Launched by SWOG CANCER RESEARCH NETWORK · Oct 4, 2016
Trial Information
Current as of April 25, 2025
Terminated
Keywords
ClinConnect Summary
PRIMARY OBJECTIVES:
I. To evaluate if there is sufficient evidence to continue to the phase III component of S1400E by comparing investigator-assessed progression-free survival (IA-PFS) between rilotumumab plus erlotinib versus erlotinib in patients registered to S1400E. (Phase II) II. To determine if there is both a statistically and clinically-meaningful difference in IA-PFS between patients randomized to receive rilotumumab plus erlotinib versus erlotinib. (Phase III) III. To compare overall survival (OS) in patients randomized to rilotumumab plus erlotinib versus erlotinib. (Phase III)...
Gender
ALL
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)
- * 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
About Swog Cancer Research Network
The SWOG Cancer Research Network is a leading cancer clinical trial organization dedicated to improving cancer treatment and outcomes through innovative research. Comprising a collaborative network of academic institutions, community hospitals, and cancer centers, SWOG conducts rigorous clinical trials that advance the understanding of cancer biology, prevention, and therapy. With a strong emphasis on inclusivity and diversity, SWOG aims to ensure that clinical research reflects the populations affected by cancer, ultimately striving to enhance patient care and quality of life. Through its commitment to scientific excellence and collaboration, SWOG plays a pivotal role in shaping the future of oncology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Pittsburgh, Pennsylvania, United States
Panorama City, California, United States
Dayton, Ohio, United States
Burlington, Wisconsin, United States
Riverside, California, United States
Los Angeles, California, United States
Bloomington, Illinois, United States
Saginaw, Michigan, United States
'Aiea, Hawaii, United States
Southfield, Michigan, United States
Dayton, Ohio, United States
Los Angeles, California, United States
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Irvine, California, United States
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Roseville, California, United States
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Stockton, California, United States
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Gainesville, Florida, United States
Torrington, Connecticut, United States
Atlanta, Georgia, United States
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Danville, Illinois, United States
Pekin, Illinois, United States
Kankakee, Illinois, United States
Pekin, Illinois, United States
Galesburg, Illinois, United States
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Denver, Colorado, United States
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South Pasadena, California, United States
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Fort Dodge, Iowa, United States
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Corbin, Kentucky, United States
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Billings, Montana, United States
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Flint, Michigan, United States
Gloucester, Massachusetts, United States
Troy, Ohio, United States
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Saint Louis Park, Minnesota, United States
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Columbus, Ohio, United States
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South San Francisco, California, United States
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Fullerton, California, United States
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Lone Tree, Colorado, United States
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Lebanon, New Hampshire, United States
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Voorhees, New Jersey, United States
Bronx, New York, United States
Springfield, Ohio, United States
Asheville, North Carolina, United States
Asheville, North Carolina, United States
Las Vegas, Nevada, United States
West Reading, Pennsylvania, United States
Oshkosh, Wisconsin, United States
Racine, Wisconsin, United States
Las Vegas, Nevada, United States
Longmont, Colorado, United States
New Haven, Connecticut, United States
North Haven, Connecticut, United States
Elmira, New York, United States
Lewes, Delaware, United States
Adrian, Michigan, United States
Adrian, Michigan, United States
Sylvania, Ohio, United States
Saint Helena, California, United States
Tiffin, Ohio, United States
Rice Lake, Wisconsin, United States
Toledo, Ohio, United States
Eau Claire, Wisconsin, United States
Wilmington, Delaware, United States
Peoria, Illinois, United States
Richmond, Virginia, United States
Rolla, Missouri, United States
Toledo, Ohio, United States
Milwaukee, Wisconsin, United States
Fremont, California, United States
East Orange, New Jersey, United States
Columbus, Ohio, United States
Mountain View, California, United States
Marietta, Ohio, United States
San Diego, California, United States
Maumee, Ohio, United States
Oregon, Ohio, United States
Salt Lake City, Utah, United States
Puyallup, Washington, United States
West Des Moines, Iowa, United States
Rockport, Maine, United States
Appleton, Wisconsin, United States
Milwaukee, Wisconsin, United States
Saint Louis, Missouri, United States
Jonesboro, Arkansas, United States
Stillwater, Minnesota, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Antioch, California, United States
Auburn, California, United States
Baldwin Park, California, United States
Bellflower, California, United States
Berkeley, California, United States
Patients applied
Trial Officials
Vassiliki Papadimitrakopoulou
Principal Investigator
SWOG Cancer Research Network
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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