Trial Search Results

Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Southwest Oncology Group

Collaborator: National Cancer Institute (NCI)

Intervention(s):

  • Drug: Docetaxel
  • Biological: Durvalumab
  • Drug: Erlotinib Hydrochloride
  • Drug: FGFR Inhibitor AZD4547
  • Biological: Ipilimumab
  • Other: Laboratory Biomarker Analysis
  • Biological: Nivolumab
  • Drug: Palbociclib
  • Other: Pharmacological Study
  • Biological: Rilotumumab
  • Drug: Talazoparib
  • Drug: Taselisib
  • Biological: Tremelimumab

Phase:

Phase 2/Phase 3

Eligibility


Inclusion Criteria:

   - SCREENING/PRE-SCREENING REGISTRATION:

   - 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 either be eligible to be screened at progression on prior treatment or
   to be pre-screened prior to progression on current treatment; patients will either
   consent to the screening consent or the pre-screening consent, not both; these
   criteria are:

      - Screening at progression on prior treatment: to be eligible for screening at
      progression, patients must have received at least one line of systemic therapy
      for any stage of disease (stages I-IV) and must have progressed during or
      following their most recent line of therapy; for patients whose prior systemic
      therapy was for stage I-III disease only (i.e. patient has not received any
      treatment for stage IV or recurrent disease), the prior systemic therapy must
      have been a platinum-based chemotherapy regimen and disease progression on the
      platinum-based chemotherapy must have occurred within one year from the last date
      that patient received that therapy; for patients whose prior therapy was for
      stage IV or recurrent disease, the patient must have received at least one line
      of a platinum-based chemotherapy regimen or checkpoint inhibitor therapy (e.g.
      nivolumab or pembrolizumab)

      - Pre-screening prior to progression on current treatment: to be eligible for
      pre-screening, current treatment must be for stage IV or recurrent disease and
      patient must have received at least one dose of the current regimen; patients
      must have previously received or currently be receiving a platinum-based
      chemotherapy regimen or checkpoint inhibitor therapy (e.g. nivolumab or
      pembrolizumab); patients on first-line platinum-based treatment are eligible upon
      receiving cycle 1, day 1 infusion; Note: patients will not receive their
      sub-study assignment until they progress and the S1400 Notice of Progression is
      submitted

   - Patients must have adequate tumor tissue available, defined as >= 20% tumor cells and
   >= 0.2 mm^3 tumor volume

      - The local interpreting pathologist must review the specimen

      - The pathologist must sign the S1400 Local Pathology Review Form confirming tissue
      adequacy prior to screening/pre-screening registration

      - Patients must agree to have this tissue submitted to Foundation Medicine for
      common broad platform Clinical Laboratory Improvement Act (CLIA) biomarker
      profiling; if archival tumor material is exhausted, then a new fresh tumor biopsy
      that is formalin-fixed and paraffin-embedded (FFPE) must be obtained; a tumor
      block or FFPE slides 4-5 microns thick must be submitted; bone biopsies are not
      allowed; if FFPE slides are to be submitted, at least 12 unstained slides plus an
      H&E stained slide, or 13 unstained slides must be submitted; however it is
      strongly recommended that 20 FFPE slides be submitted; Note: previous
      next-generation deoxyribonucleic acid (DNA) sequencing (NGS) will be repeated if
      done outside this study for sub-study assignment; patients must agree to have any
      tissue that remains after NGS testing retained for the use of the translational
      medicine (TM) studies (if such TM studies are defined) within any sub-study the
      patient is enrolled in

   - 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 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

   - SUB-STUDY REGISTRATION:

   - 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

   - Patients must have progressed (in the opinion of the treating investigator) following
   the most recent line of therapy

   - 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 have measurable disease documented by computed tomography (CT) or
   magnetic resonance imaging (MRI); the CT from a combined positron emission tomography
   (PET)/CT may be used to document only non-measurable disease unless it is of
   diagnostic quality; measurable disease must be assessed within 28 days prior to
   sub-study registration; pleural effusions, ascites and laboratory parameters are not
   acceptable as the only evidence of disease; non-measurable disease must be assessed
   within 42 days prior to sub-study registration; all disease must be assessed and
   documented on the Baseline Tumor Assessment Form; patients whose only measurable
   disease is within a previous radiation therapy port must demonstrate clearly
   progressive disease (in the opinion of the treating investigator) prior to
   registration

   - Patients must have a CT or MRI scan of the brain to evaluate for central nervous
   system (CNS) disease within 42 days prior to sub-study registration; patient must not
   have leptomeningeal disease, spinal cord compression or brain metastases unless: (1)
   metastases have been locally treated and have remained clinically controlled and
   asymptomatic for at least 14 days following treatment and prior to registration, AND
   (2) patient has no residual neurological dysfunction and has been off corticosteroids
   for at least 24 hours prior to sub-study registration

   - Patient must have fully recovered from the effects of prior surgery at least 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

   - Absolute neutrophil count (ANC) >= 1,500/mcl obtained within 28 days prior to
   sub-study registration

   - Platelet count >= 100,000 mcl obtained within 28 days prior to sub-study registration

   - Hemoglobin >= 9 g/dL obtained within 28 days prior to sub-study registration

   - Serum bilirubin =< institutional upper limit of normal (IULN) within 28 days prior to
   sub-study registration; for patients with liver metastases, bilirubin must be =< 5 x
   IULN

   - Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN
   within 28 days prior to sub-study registration (if both ALT and AST are done, both
   must be =< 2 IULN); for patients with liver metastases, either ALT or AST must be =< 5
   x IULN (if both ALT and AST are done, both must be =< 5 x IULN)

   - Serum creatinine =< the IULN OR measured or calculated creatinine clearance >= 50
   mL/min using the following Cockcroft-Gault Formula within 28 days prior to sub-study
   registration

   - Patients must have Zubrod performance status 0-1 documented within 28 days prior to
   sub-study registration

   - 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

   - Patients with a known history of human immunodeficiency virus (HIV) seropositivity:

      - Must have undetectable viral load using standard HIV assays in clinical practice

      - Must have cluster of differentiation (CD)4 count >= 400/mcL

      - Must not require prophylaxis for any opportunistic infections (i.e., fungal,
      Mycobacterium avium complex [mAC], or pneumocystis jiroveci pneumonia [PCP]
      prophylaxis)

      - Must not be newly diagnosed within 12 months prior to sub-study registration

   - Prestudy history and physical exam must be obtained within 28 days prior to sub-study
   registration

   - No other prior malignancy is allowed except for the following: adequately treated
   basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
   stage I or II cancer from which the patient is currently in complete remission, or any
   other cancer from which the patient has been disease free for five years

   - Patients must not be pregnant or nursing; women/men of reproductive potential must
   have agreed to use an effective contraceptive method; a woman is considered to be of
   "reproductive potential" if she has had menses at any time in the preceding 12
   consecutive months; in addition to routine contraceptive methods, "effective
   contraception" also includes heterosexual celibacy and surgery intended to prevent
   pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy,
   bilateral oophorectomy or bilateral tubal ligation; however, if at any point a
   previously celibate patient chooses to become heterosexually active during the time
   period for use of contraceptive measures outlined in the protocol, he/she is
   responsible for beginning contraceptive measures

   - As part of the 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 into the system

   - Patients with impaired decision-making capacity are eligible as long as their
   neurological or psychological condition does not preclude their safe participation in
   the study (e.g., tracking pill consumption and reporting adverse events to the
   investigator)

   - 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting