Skip Navigation Links
A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
Overall Recruitment Status: Active, currently enrolling
Official Title
A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
Region Sponsors
Southwest Oncology Group
Acronym KP IRB No.
Study Type Phase
Clinical Trial Phase IIB
Study Population Description
Recurrent Squamous Cell Lung Carcinoma; Stage IV Squamous Cell Lung Carcinoma AJCC v;
This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a ?non-match? sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.
Detailed Description
Gender Age Limit
Male & Female
Inclusion Criteria
  • Patients must have pathologically proven squamous cell carcinoma (SCCA) cancer of the lung confirmed by tumor biopsy and/or fine-needle aspiration, disease must be stage IV SCCA, or recurrent. The primary diagnosis of SCCA should be established using the current World Health Organization (WHO)/International Association for the Study of Lung Cancer (IASLC)-classification of Thoracic Malignancies, the diagnosis is based on hematoxylin and eosin (H&E) stained slides with or without specific defined immunohistochemistry (IHC) characteristic (p40/p63 positive, transcription termination factor [TTF1] negative) if required for diagnosis.
  • Mixed histologies are not allowed.
  • Patients must have Zubrod performance status 0-1 documented within 28 days prior to screening/pre-screening registration
  • Patients must also be offered participation in banking for future use of specimens
  • Patients must be willing to provide prior smoking history as required on the S1400 Onstudy Form
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • Patients whose biomarker profiling results indicate the presence of an EGFR mutation or echinoderm microtubule-associated protein-like 4 (EML4)/ALK fusion are not eligible
  • Please contact study personnel for more eligibility criteria
Exclusion Criteria
  • Patients must not have a known epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion
  • EGFR/ALK testing is not required prior to registration and is included in the Foundation Medicine Incorporated (FMI) testing for screening/prescreening
  • Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration. Patients must have recovered (=< grade 1) from any side effects of prior therapy. Patients must not have received any radiation therapy within 14 days prior to sub-study registration
  • Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
  • Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
  • Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection
  • Please contact study personnel for more eligibility criteria

Keywords and/or Specific Medical Conditions
  • Lung adenocarcinoma
  • Oncology (Adult)
  • Lung cancer
KP Clinical Facility
  • Burke Medical Center
  • Capitol Hill Medical Center
  • Gaithersburg Medical Center
  • Largo Medical Center
  • Tyson's Corner Medical Center
  • Woodlawn Medical Center
Clinical Area
  • Oncology (Adult)

Principal Investigator:
Leon Hwang, MD
Contact Information:
- Leslie Greenburg, MS, RN
-Gaithersburg Medical Center

Do you want to receive
Email Alerts?

Sign Up Here!

Regional Research Sites: