Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer

Not Recruiting

Trial ID: NCT01822496


This randomized phase II trial studies how well erlotinib hydrochloride or crizotinib with chemoradiation therapy works in treating patients with stage III non-small cell lung cancer. Radiation therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, etoposide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving erlotinib hydrochloride is more effective than crizotinib with chemoradiation therapy in treating patients with non-small cell lung cancer.

Official Title

A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-small Cell Lung Cancer (NSCLC)

Stanford Investigator(s)


Professor of Radiation Oncology (Radiation Therapy)

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Maximilian Diehn, MD, PhD
Maximilian Diehn, MD, PhD

Jack, Lulu, and Sam Willson Professor and Professor of Radiation Oncology (Radiation Therapy)

Kavitha Ramchandran
Kavitha Ramchandran

Clinical Professor, Medicine - Oncology

Millie Das
Millie Das

Clinical Associate Professor, Medicine - Oncology

Heather Wakelee
Heather Wakelee

Professor of Medicine (Oncology)


Inclusion Criteria:

   - Histologically or cytologically confirmed, newly diagnosed non-squamous NSCLC

   - Unresectable stage IIIA or IIIB disease; patients must be surgically staged to confirm
   N2 or N3 disease; patients may have invasive mediastinal staging by mediastinoscopy,
   mediastinotomy, endobronchial ultrasound transbronchial aspiration (EBUS-TBNA),
   endoscopic ultrasound (EUS), or video-assisted thoracoscopic surgery (VATS)

   - Patients with any tumor (T) with node (N)2 or N3 are eligible; patients with T3, N1-N3
   disease are eligible if deemed unresectable; patients with T4, any N are eligible

   - Patients must have measurable disease, i.e., lesions that can be accurately measured
   in at least 1 dimension (longest dimension in the plane of measurement is to be
   recorded) with a minimum size of 10 mm by computed tomography (CT) scan (CT scan slice
   thickness no greater than 5 mm)

   - Patients with a pleural effusion, which is a transudate, cytologically negative and
   non-bloody, are eligible if the radiation oncologist feels the tumor can be
   encompassed within a reasonable field of radiotherapy

   - If a pleural effusion can be seen on the chest CT but not on chest x-ray and is too
   small to tap, the patient will be eligible; patients who develop a new pleural
   effusion after thoracotomy or other invasive thoracic procedure will be eligible

   - The institution's pre-enrollment biomarker screening at a Clinical Laboratory
   Improvement Amendments (CLIA) certified lab documents presence of known "sensitive"
   mutations in epidermal growth factor receptor tyrosine kinase (EGFR TK) domain (exon
   19 deletion, L858) and/or EML4-anaplastic lymphoma kinase (ALK) fusion arrangement;
   either the primary tumor or the metastatic lymph node tissue may be used for testing
   of mutations

   - The institution's pre-enrollment biomarker screening at a CLIA certified lab documents
   absence of T790M mutation in the EGFR TK domain

   - Appropriate stage for protocol entry, including no distant metastases, based upon the
   following minimum diagnostic workup:

      - History/physical examination, including recording of pulse, blood pressure (BP),
      weight, and body surface area, within 45 days prior to registration

      - Whole body fludeoxyglucose-positron emission tomography (FDG-PET)/CT (orbits to
      mid-thighs) within 30 days prior to registration; PET/CT must be negative for
      distant metastasis

      - CT scan with contrast of the chest and upper abdomen to include liver and
      adrenals (unless medically contraindicated) within 30 days prior to registration

      - Magnetic resonance imaging (MRI) of the brain with contrast (or CT scan with
      contrast, if MRI medically contraindicated) within 30 days prior to registration

   - Zubrod performance status 0-1 within 14 days prior to registration

   - Absolute neutrophil count (ANC) >= 1,000 cells/mm^3

   - Platelets >= 100,000 cells/mm^3

   - Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve
   hemoglobin [Hgb] >= 8.0 g/dl is acceptable)

   - Serum creatinine < 1.5 mg/dL or calculated creatinine clearance >= 50 ml/min (by
   Cockcroft-Gault formula) within 14 days prior to registration

   - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit
   of normal (ULN) within 14 days prior to registration

   - Bilirubin within normal institutional limits within 14 days prior to registration

   - Negative serum pregnancy test within 14 days prior to registration for women of
   childbearing potential

   - Patient must provide study specific informed consent prior to study entry, including
   consent for mandatory screening of tissue

Exclusion Criteria:

   - Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
   for a minimum of 730 days (2 years) (for example, carcinoma in situ of the breast,
   oral cavity, or cervix are all permissible)

   - Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
   different cancer is allowable

   - Prior radiotherapy to the region of the study cancer that would result in overlap of
   radiation therapy fields

   - Atelectasis of the entire lung

   - Contralateral hilar node involvement

   - Exudative, bloody, or cytologically malignant effusions

   - Severe, active co-morbidity, defined as follows:

      - Unstable angina and/or congestive heart failure requiring hospitalization within
      the last 6 months

      - Transmural myocardial infarction within the last 6 months

      - Acute bacterial or fungal infection requiring intravenous antibiotics at the time
      of registration

      - Chronic obstructive pulmonary disease exacerbation or other respiratory illness
      requiring hospitalization or precluding study therapy at the time of
      registration; hepatic insufficiency resulting in clinical jaundice and/or
      coagulation defects

      - Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease
      Control and Prevention (CDC) definition; note, however, that human
      immunodeficiency virus (HIV) testing is not required for entry into this
      protocol; protocol-specific requirements may also exclude immuno-compromised

   - Pregnancy or women of childbearing potential and men who are sexually active and not
   willing/able to use medically acceptable forms of contraception

   - Prior allergic reaction to the study drug(s) involved in this protocol


drug: cisplatin

drug: etoposide

drug: paclitaxel

drug: carboplatin

drug: crizotinib

radiation: Radiation Therapy

drug: Erlotinib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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