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Trial record 1 of 1 for:    rtog 1306
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Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01822496
Recruitment Status : Active, not recruiting
First Posted : April 2, 2013
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stage III Non-Small Cell Lung Cancer AJCC v7 Stage IIIA Non-Small Cell Lung Cancer AJCC v7 Stage IIIB Non-Small Cell Lung Cancer AJCC v7 Radiation: 3-Dimensional Conformal Radiation Therapy Drug: Carboplatin Drug: Cisplatin Drug: Crizotinib Drug: Erlotinib Hydrochloride Drug: Etoposide Radiation: Intensity-Modulated Radiation Therapy Other: Laboratory Biomarker Analysis Drug: Paclitaxel Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess whether patients with unresectable local-regionally advanced non-small cell lung cancer (NSCLC) treated with targeted agents based on molecular characteristics have a longer progression-free survival than those treated with standard care therapy alone.

SECONDARY OBJECTIVES:

I. To evaluate response rate. II. To assess toxicity. III. To assess overall survival. IV. To correlate clinical outcomes with tumor molecular aberrations identified from deep sequencing of selected kinomes in patients from whom adequate baseline tissue is available.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

ARM I (induction therapy): Patients receive erlotinib hydrochloride orally (PO) once daily (QD) for up to 12 weeks. Patients who have had no response (partial or complete) after 6 weeks undergo concurrent chemoradiation therapy immediately. After 2 weeks of completion of induction therapy, patients receive chemoradiation.

ARM III (induction therapy): Patients receive crizotinib PO twice daily (BID) for up to 12 weeks. Patients who have had no response (partial or complete) after 6 weeks undergo concurrent chemoradiation therapy immediately. After 2 weeks of completion of induction therapy, patients receive chemoradiation.

ARMS II AND IV (concurrent chemoradiation): Patients receive concurrent chemotherapy with thoracic radiation therapy beginning on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.

CHEMORADIATION: In all treatment arms, patients undergo concurrent intensity modulated radiation therapy (IMRT) or 3-dimensional conformal radiation therapy (3-D CRT) QD 5 days a week for 6 weeks. Patients receive 1 of 2 chemotherapy regimens based on the discretion of the treating physician. Patients receive cisplatin intravenously (IV) over 1-2 hours on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Some patients receive paclitaxel IV and carboplatin IV on days 1, 8, 15, 22, 29, and 36 during radiation therapy for 6 weeks. Two courses of consolidation treatment will begin 4-6 weeks after completion of radiation therapy with paclitaxel IV on days 1 and 22 and carboplatin IV on days 1 and 22 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 and 2 months, 4-6 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-small Cell Lung Cancer (NSCLC)
Actual Study Start Date : November 4, 2013
Estimated Primary Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm I (erlotinib hydrochloride, concurrent chemoradiation)
Patients receive erlotinib hydrochloride PO QD for up to 12 weeks. Patients who have had no response (partial or complete) after 6 weeks undergo concurrent chemoradiation therapy immediately. After 2 weeks of completion of induction therapy, patients receive chemoradiation.
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo 3-D CRT
Other Names:
  • 3-dimensional radiation therapy
  • 3D CONFORMAL RADIATION THERAPY
  • 3D CRT
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Drug: Erlotinib Hydrochloride
Given PO
Other Names:
  • Cp-358,774
  • OSI-774
  • Tarceva
Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16-213
  • VP-16
  • VP-16-213
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat
Active Comparator: Arm II (chemoradiation, EGFR TK Mutation Cohort)
Patients receive concurrent chemotherapy with thoracic radiation therapy beginning on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo 3-D CRT
Other Names:
  • 3-dimensional radiation therapy
  • 3D CONFORMAL RADIATION THERAPY
  • 3D CRT
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16-213
  • VP-16
  • VP-16-213
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat
Experimental: Arm III (crizotinib, concurrent chemoradiation)
Patients receive crizotinib PO BID for up to 12 weeks. Patients who have had no response (partial or complete) after 6 weeks undergo concurrent chemoradiation therapy immediately. After 2 weeks of completion of induction therapy, patients receive chemoradiation.
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo 3-D CRT
Other Names:
  • 3-dimensional radiation therapy
  • 3D CONFORMAL RADIATION THERAPY
  • 3D CRT
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Drug: Crizotinib
Given PO
Other Names:
  • MET Tyrosine Kinase Inhibitor PF-02341066
  • PF-02341066
  • PF-2341066
  • Xalkori
Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16-213
  • VP-16
  • VP-16-213
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat
Active Comparator: Arm IV (chemoradiation, ALK Tran L Cohort)
Patients receive concurrent chemotherapy with thoracic radiation therapy beginning on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo 3-D CRT
Other Names:
  • 3-dimensional radiation therapy
  • 3D CONFORMAL RADIATION THERAPY
  • 3D CRT
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16-213
  • VP-16
  • VP-16-213
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat



Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Occurrence of local or regional progression, distant metastases, or death from any cause from the time of randomization to the occurrence of one of the failure events, whichever occurs first, assessed up to 12 months ]
    The product limit estimator developed by Kaplan and Meier will be used. Their 95% confidence intervals will be estimated. Comparisons between arms will be conducted using a log rank test.


Secondary Outcome Measures :
  1. Deep sequencing of selected kinomes in patients from whom adequate baseline tissue is available [ Time Frame: Baseline ]
    Tumor molecular aberrations identified from deep sequencing of selected kinomes will be correlated with clinical outcomes.

  2. Distant progression free survival [ Time Frame: Time from randomization to distant progression or death, whichever occurs first, assessed up to 10 years ]
    Appropriate methods for competing risks will be applied, specifically cumulative incidence functions for estimation of cumulative cause specific event probabilities with associated testing for differences, and regression methods for cause-specific hazards and subdistribution hazards underlying cumulative incidence functions may be applied accordingly for exploratory purposes.

  3. Incidence of grade 3-5 adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 [ Time Frame: Up to 10 years ]
    Summarized using frequency table methods.

  4. Local-regional progression free survival [ Time Frame: Time from randomization to local-regional progression or death, whichever comes first, assessed up to 10 years ]
    Appropriate methods for competing risks will be applied, specifically cumulative incidence functions for estimation of cumulative cause specific event probabilities with associated testing for differences, and regression methods for cause-specific hazards and subdistribution hazards underlying cumulative incidence functions may be applied accordingly for exploratory purposes.

  5. Overall survival [ Time Frame: Time to death from any cause, assessed up to 12 months ]
    The product limit estimator developed by Kaplan and Meier will be used. Their 95% confidence intervals will be estimated. Comparisons between arms will be conducted using a log rank test.

  6. Proportion of patients who respond (completely or partially) to each treatment, assessed by the Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to 10 years ]
    Estimated as well as their 95% confidence intervals. Response rate will be tested using Fisher's exact test and using a logistic regression model to incorporate other prognostic covariates.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 patients
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822496


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
United States, Alaska
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, Arizona
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, California
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, United States, 93301
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Fremont - Rideout Cancer Center
Marysville, California, United States, 95901
Mercy UC Davis Cancer Center
Merced, California, United States, 95340
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Saint Helena Hospital
Saint Helena, California, United States, 94574
UCSF Medical Center-Mount Zion
San Francisco, California, United States, 94115
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, United States, 96161
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States, 80304
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States, 80909
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
North Colorado Medical Center
Greeley, Colorado, United States, 80631
McKee Medical Center
Loveland, Colorado, United States, 80539
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Delaware
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Baptist Medical Center South
Jacksonville, Florida, United States, 32258
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
21st Century Oncology-Palatka
Palatka, Florida, United States, 32177
Memorial Hospital West
Pembroke Pines, Florida, United States, 33028
Integrated Community Oncology Network-Flager Cancer Center
Saint Augustine, Florida, United States, 32086
Robert and Carol Weissman Cancer Center at Martin Health
Stuart, Florida, United States, 34994
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, United States, 30501
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Hawaii
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States, 96817
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
University of Illinois
Chicago, Illinois, United States, 60612
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
AMITA Health Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
Elmhurst Memorial Hospital
Elmhurst, Illinois, United States, 60126
AMITA Health Cancer Institute and Outpatient Center
Hinsdale, Illinois, United States, 60521
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Edward Hospital/Cancer Center
Naperville, Illinois, United States, 60540
Edward Hospital/Cancer Center?Plainfield
Plainfield, Illinois, United States, 60585
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, United States, 61114
Memorial Medical Center
Springfield, Illinois, United States, 62781
United States, Indiana
Saint Vincent Anderson Regional Hospital/Cancer Center
Anderson, Indiana, United States, 46016
Radiation Oncology Associates PC
Fort Wayne, Indiana, United States, 46804
Parkview Hospital Randallia
Fort Wayne, Indiana, United States, 46805
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Saint Luke's Hospital
Cedar Rapids, Iowa, United States, 52402
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
United States, Maine
Harold Alfond Center for Cancer Care
Augusta, Maine, United States, 04330
Maine Medical Center- Scarborough Campus
Scarborough, Maine, United States, 04074
United States, Maryland
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
Beaumont Hospital-Dearborn
Dearborn, Michigan, United States, 48124
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
United States, Minnesota
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Unity Hospital
Fridley, Minnesota, United States, 55432
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Mayo Clinic
Rochester, Minnesota, United States, 55905
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
United States, Missouri
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States, 65401
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States, 63141
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, New Hampshire
Concord Hospital
Concord, New Hampshire, United States, 03301
Elliot Hospital
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Virtua Memorial
Mount Holly, New Jersey, United States, 08060
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Community Medical Center
Toms River, New Jersey, United States, 08755
Virtua Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87102
United States, New York
Mary Imogene Bassett Hospital
Cooperstown, New York, United States, 13326
Beth Israel Medical Center
New York, New York, United States, 10003
Mount Sinai Hospital
New York, New York, United States, 10029
Weill Medical College of Cornell University
New York, New York, United States, 10065
University of Rochester
Rochester, New York, United States, 14642
Staten Island University Hospital
Staten Island, New York, United States, 10305
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Cancer Care of Western North Carolina
Asheville, North Carolina, United States, 28801
Mission Hospital-Memorial Campus
Asheville, North Carolina, United States, 28801
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44307
Summa Barberton Hospital
Barberton, Ohio, United States, 44203
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Grant Medical Center
Columbus, Ohio, United States, 43215
The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Mercy Cancer Center-Elyria
Elyria, Ohio, United States, 44035
Cleveland Clinic Cancer Center Independence
Independence, Ohio, United States, 44131
North Coast Cancer Care
Sandusky, Ohio, United States, 44870
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, United States, 44136
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio, United States, 44691
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States, 97210
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Kaiser Permanente Northwest
Portland, Oregon, United States, 97227
Salem Hospital
Salem, Oregon, United States, 97301
United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, United States, 18840
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States, 29615
Self Regional Healthcare
Greenwood, South Carolina, United States, 29646
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States, 29650
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States, 29651
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Spartanburg Medical Center
Spartanburg, South Carolina, United States, 29303
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, Texas
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, United States, 79106
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Covenant Medical Center-Lakeside
Lubbock, Texas, United States, 79410
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
Dixie Medical Center Regional Cancer Center
Saint George, Utah, United States, 84770
United States, Washington
PeaceHealth Saint John Medical Center
Longview, Washington, United States, 98632
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
United States, West Virginia
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States, 25701
United States, Wisconsin
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States, 54303
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States, 53051
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States, 53097
Columbia Saint Mary's Water Tower Medical Commons
Milwaukee, Wisconsin, United States, 53211
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States, 54017
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
The Alyce and Elmore Kraemer Cancer Care Center
West Bend, Wisconsin, United States, 53095
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ramaswamy Govindan NRG Oncology

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01822496     History of Changes
Other Study ID Numbers: NCI-2013-00737
NCI-2013-00737 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RTOG-1306 ( Other Identifier: NRG Oncology )
RTOG-1306 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA021661 ( U.S. NIH Grant/Contract )
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: December 2017

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Carboplatin
Erlotinib Hydrochloride
Etoposide
Paclitaxel
Cisplatin
Podophyllotoxin
Crizotinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Keratolytic Agents
Dermatologic Agents