<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02225405</url>
  </required_header>
  <id_info>
    <org_study_id>2013-0844</org_study_id>
    <secondary_id>NCI-2014-02091</secondary_id>
    <secondary_id>2013-0844</secondary_id>
    <nct_id>NCT02225405</nct_id>
  </id_info>
  <brief_title>Cisplatin, Docetaxel, and Nintedanib Before Surgery in Treating Patients With Previously Untreated Stage IB-IIIA Non-small Cell Lung Cancer</brief_title>
  <official_title>Phase I Study of Induction Cisplatin, Docetaxel, and Nintedanib for Stage IB-IIIA Non-Small Cell Lung Cancers Amenable for Surgical Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase I trial studies the side effects and best dose of nintedanib when given together&#xD;
      with cisplatin and docetaxel and to see how well they work in treating patients with&#xD;
      previously untreated stage IB-IIIA non-small cell lung cancer who are undergoing surgery.&#xD;
      Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop&#xD;
      the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by&#xD;
      stopping them from spreading. Nintedanib may stop the growth of tumor cells by blocking some&#xD;
      of the enzymes needed for cell growth. Giving cisplatin, docetaxel, and nintedanib before&#xD;
      surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be&#xD;
      removed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine safety of nintedanib incorporated to chemotherapy in the induction setting.&#xD;
&#xD;
      II. To determine the major pathologic response rate in patients treated with induction&#xD;
      nintedanib and chemotherapy.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Response rates to induction treatment (by Response Evaluation Criteria in Solid Tumors&#xD;
      [RECIST] version 1.1).&#xD;
&#xD;
      II. Response rates to priming therapy with nintedanib single agent (by computed tomography&#xD;
      [CT] assessment using RECIST version 1.1).&#xD;
&#xD;
      III. Recurrence-free survival. IV. Overall survival. V. Correlations between major pathologic&#xD;
      response with recurrence-free and overall survival.&#xD;
&#xD;
      VI. Toxicity (assessed by the National Cancer Institute [NCI] Common Terminology Criteria for&#xD;
      Adverse Events [CTCAE] version 4).&#xD;
&#xD;
      VII. Peri-operative morbidity and mortality. VIII. Complete resection (R0) rate. IX.&#xD;
      Correlations of response assessed by imaging studies with outcomes (both pathologic response&#xD;
      to treatment and long-term recurrence-free survival).&#xD;
&#xD;
      X. Correlations of blood- and tissue-based biomarkers with efficacy and toxicity.&#xD;
&#xD;
      OUTLINE: This is a dose-escalation study of nintedanib.&#xD;
&#xD;
      RUN-IN PHASE: Patients receive induction therapy comprising cisplatin intravenously (IV) over&#xD;
      2 hours on day 1, docetaxel IV over 1 hour on day 1, and nintedanib orally (PO) twice daily&#xD;
      (BID) from day 2 of course 1 to day 7 of course 3. Treatment repeats every 21 days for up to&#xD;
      3 courses in the absence of disease progression or unacceptable toxicity. Patients then&#xD;
      undergo surgery.&#xD;
&#xD;
      EXPANSION PHASE: Patients receive single-agent nintedanib PO BID on days 1-28. Patients then&#xD;
      receive 3 courses of induction chemotherapy and undergo surgery as above. Treatment continues&#xD;
      even if patients experience disease progression, unless treatment is judged to be not in the&#xD;
      best interest of the patient by the treating physician.&#xD;
&#xD;
      After completion of study treatment, patients are followed up within 8 weeks and then&#xD;
      periodically thereafter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 3, 2015</start_date>
  <completion_date type="Anticipated">April 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum tolerated dose (MTD) of nintedanib</measure>
    <time_frame>21 days</time_frame>
    <description>Will be determined according to incidence of dose-limiting toxicity as graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Major pathologic response rate, defined as less than or equal to 10% viable tumor cells in the resected specimen using the methods described by Pataer</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Multivariate analysis will be used to explore the role of biomarkers in predicting pathologic response to treatment, in an exploratory way.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in tumor size (Expansion phase)</measure>
    <time_frame>Baseline to 4 weeks</time_frame>
    <description>Will be assessed by computed tomography (CT) after single-agent nintedanib.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate after single-agent nintedanib (Expansion phase)</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Stage IB Non-Small Cell Lung Carcinoma AJCC v7</condition>
  <condition>Stage II Non-Small Cell Lung Cancer AJCC v7</condition>
  <condition>Stage IIA Non-Small Cell Lung Carcinoma AJCC v7</condition>
  <condition>Stage IIB Non-Small Cell Lung Carcinoma AJCC v7</condition>
  <condition>Stage IIIA Non-Small Cell Lung Cancer AJCC v7</condition>
  <arm_group>
    <arm_group_label>Treatment (cisplatin, docetaxel, nintedanib)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RUN-IN PHASE: Patients receive induction therapy comprising cisplatin IV over 2 hours on day 1, docetaxel IV over 1 hour on day 1, and nintedanib PO BID from day 2 of course 1 to day 7 of course 3. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.&#xD;
EXPANSION PHASE: Patients receive single-agent nintedanib PO BID on days 1-28. Patients then receive 3 courses of induction chemotherapy and undergo surgery as above. Treatment continues even if patients experience disease progression, unless treatment is judged to be not in the best interest of the patient by the treating physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (cisplatin, docetaxel, nintedanib)</arm_group_label>
    <other_name>Abiplatin</other_name>
    <other_name>Blastolem</other_name>
    <other_name>Briplatin</other_name>
    <other_name>CDDP</other_name>
    <other_name>Cis-diammine-dichloroplatinum</other_name>
    <other_name>Cis-diamminedichloridoplatinum</other_name>
    <other_name>Cis-diamminedichloro Platinum (II)</other_name>
    <other_name>Cis-diamminedichloroplatinum</other_name>
    <other_name>Cis-dichloroammine Platinum (II)</other_name>
    <other_name>Cis-platinous Diamine Dichloride</other_name>
    <other_name>Cis-platinum</other_name>
    <other_name>Cis-platinum II</other_name>
    <other_name>Cis-platinum II Diamine Dichloride</other_name>
    <other_name>Cismaplat</other_name>
    <other_name>Cisplatina</other_name>
    <other_name>Cisplatinum</other_name>
    <other_name>Cisplatyl</other_name>
    <other_name>Citoplatino</other_name>
    <other_name>Citosin</other_name>
    <other_name>Cysplatyna</other_name>
    <other_name>DDP</other_name>
    <other_name>Lederplatin</other_name>
    <other_name>Metaplatin</other_name>
    <other_name>Neoplatin</other_name>
    <other_name>Peyrone's Chloride</other_name>
    <other_name>Peyrone's Salt</other_name>
    <other_name>Placis</other_name>
    <other_name>Plastistil</other_name>
    <other_name>Platamine</other_name>
    <other_name>Platiblastin</other_name>
    <other_name>Platiblastin-S</other_name>
    <other_name>Platinex</other_name>
    <other_name>Platinol</other_name>
    <other_name>Platinol- AQ</other_name>
    <other_name>Platinol-AQ</other_name>
    <other_name>Platinol-AQ VHA Plus</other_name>
    <other_name>Platinoxan</other_name>
    <other_name>Platinum</other_name>
    <other_name>Platinum Diamminodichloride</other_name>
    <other_name>Platiran</other_name>
    <other_name>Platistin</other_name>
    <other_name>Platosin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (cisplatin, docetaxel, nintedanib)</arm_group_label>
    <other_name>Docecad</other_name>
    <other_name>RP56976</other_name>
    <other_name>Taxotere</other_name>
    <other_name>Taxotere Injection Concentrate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (cisplatin, docetaxel, nintedanib)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nintedanib</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (cisplatin, docetaxel, nintedanib)</arm_group_label>
    <other_name>BIBF 1120</other_name>
    <other_name>BIBF-1120</other_name>
    <other_name>Intedanib</other_name>
    <other_name>Multitargeted Tyrosine Kinase Inhibitor BIBF 1120</other_name>
    <other_name>tyrosine kinase inhibitor BIBF 1120</other_name>
    <other_name>Vargatef</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed non-small cell lung cancer; patients with a&#xD;
             suspected lung cancer are eligible, but pathology must be confirmed prior to&#xD;
             initiating treatment on study; neuroendocrine carcinomas are not eligible; carcinomas&#xD;
             with neuroendocrine differentiation are eligible&#xD;
&#xD;
          -  Stage IB (with a primary tumor &gt;= 4 cm), IIA, IIB, or IIIA (according to American&#xD;
             Joint Committee on Cancer [AJCC] 7th edition); patients with stage IIIA must not have&#xD;
             more than one mediastinal lymph node station involved by tumor&#xD;
&#xD;
          -  All patients must have lymph node evaluation of contralateral stations 2 and/or 4 to&#xD;
             exclude N3 disease&#xD;
&#xD;
          -  The patient must be a suitable candidate for surgery, in the opinion of the treating&#xD;
             physician&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status score 0-1&#xD;
&#xD;
          -  Signed and dated written informed consent prior to admission to the study in&#xD;
             accordance with International Conference on Harmonization of Technical Requirements&#xD;
             for Registration of Pharmaceuticals for Human Use (ICH)-Good Clinical Practice (GCP)&#xD;
             guidelines and to the local legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior systemic therapy or radiation therapy for treatment of the current lung cancer&#xD;
&#xD;
          -  Known hypersensitivity to the trial drugs or to their excipients&#xD;
&#xD;
          -  Centrally located tumors with radiographic evidence (CT or magnetic resonance imaging&#xD;
             [MRI]) of local invasion of major blood vessels&#xD;
&#xD;
          -  Major injuries within the past 10 days prior to start of study treatment with&#xD;
             incomplete wound healing&#xD;
&#xD;
          -  History of clinically significant hemorrhagic or thromboembolic event in the past 6&#xD;
             months&#xD;
&#xD;
          -  Known inherited predisposition to bleeding or thrombosis&#xD;
&#xD;
          -  Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina,&#xD;
             history of infarction within the past 12 months prior to start of study treatment,&#xD;
             congestive heart failure &gt; New York Heart Association [NYHA] II, serious cardiac&#xD;
             arrhythmia, pericardial effusion)&#xD;
&#xD;
          -  Creatinine &gt; 1.5 x the upper limit of normal; patients with creatinine &gt; 1.5 x the&#xD;
             upper limit of normal who have creatinine clearance &gt;= 60 cc/min (calculated using the&#xD;
             Cockcroft and Gault equation) are eligible&#xD;
&#xD;
          -  Total bilirubin &gt; institutional upper limit of normal or&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) &gt; 1.5 x institutional upper limit of normal&#xD;
&#xD;
          -  International normalized ratio (INR) &gt; 2&#xD;
&#xD;
          -  Prothrombin time (PT) and partial thromboplastin time (PTT) &gt; 50% of deviation of&#xD;
             institutional upper limit of normal (ULN)&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &lt; 1500/ml, and/or&#xD;
&#xD;
          -  Platelets &lt; 100000/ml&#xD;
&#xD;
          -  Prior malignancy requiring systemic therapy or radiation therapy within 1 year of&#xD;
             randomization&#xD;
&#xD;
          -  Active serious infections in particular if requiring systemic antibiotic or&#xD;
             antimicrobial therapy&#xD;
&#xD;
          -  Known disease or history of active or chronic hepatitis C and/or B infection&#xD;
&#xD;
          -  Gastrointestinal disorders or abnormalities that would interfere with absorption of&#xD;
             the study drug&#xD;
&#xD;
          -  Serious illness or concomitant non-oncological disease such as neurologic,&#xD;
             psychiatric, infectious disease or laboratory abnormality that may increase the risk&#xD;
             associated with study participation or study drug administration and in the judgment&#xD;
             of the investigator would make the patient inappropriate for entry into the study&#xD;
&#xD;
          -  Patients who are sexually active, with preserved reproductive capacity, and unwilling&#xD;
             to use a medically acceptable method of contraception (e.g. such as implants,&#xD;
             injectables, combined oral contraceptives, some intrauterine devices or vasectomized&#xD;
             partner for participating females, condoms for participating males) during the trial&#xD;
             and for at least three months after end of active therapy&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Psychological, familial, sociological or geographical factors potentially hampering&#xD;
             compliance with the study protocol and follow-up schedule&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tina Cascone</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Nintedanib</mesh_term>
    <mesh_term>Tyrosine Protein Kinase Inhibitors</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02225405
org study id: 2013-0844
secondary id: NCI-2014-02091
secondary id: 2013-0844
nct id: NCT02225405
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
This phase I trial studies the side effects and best dose of nintedanib when given together
      with cisplatin and docetaxel and to see how well they work in treating patients with
      previously untreated stage IB-IIIA non-small cell lung cancer who are undergoing surgery.
      Drugs used in chemotherapy, such as cisplatin and docetaxel, 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. Nintedanib may stop the growth of tumor cells by blocking some
      of the enzymes needed for cell growth. Giving cisplatin, docetaxel, and nintedanib before
      surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be
      removed.
PRIMARY OBJECTIVES:

      I. To determine safety of nintedanib incorporated to chemotherapy in the induction setting.

      II. To determine the major pathologic response rate in patients treated with induction
      nintedanib and chemotherapy.

      SECONDARY OBJECTIVES:

      I. Response rates to induction treatment (by Response Evaluation Criteria in Solid Tumors
      [RECIST] version 1.1).

      II. Response rates to priming therapy with nintedanib single agent (by computed tomography
      [CT] assessment using RECIST version 1.1).

      III. Recurrence-free survival. IV. Overall survival. V. Correlations between major pathologic
      response with recurrence-free and overall survival.

      VI. Toxicity (assessed by the National Cancer Institute [NCI] Common Terminology Criteria for
      Adverse Events [CTCAE] version 4).

      VII. Peri-operative morbidity and mortality. VIII. Complete resection (R0) rate. IX.
      Correlations of response assessed by imaging studies with outcomes (both pathologic response
      to treatment and long-term recurrence-free survival).

      X. Correlations of blood- and tissue-based biomarkers with efficacy and toxicity.

      OUTLINE: This is a dose-escalation study of nintedanib.

      RUN-IN PHASE: Patients receive induction therapy comprising cisplatin intravenously (IV) over
      2 hours on day 1, docetaxel IV over 1 hour on day 1, and nintedanib orally (PO) twice daily
      (BID) from day 2 of course 1 to day 7 of course 3. Treatment repeats every 21 days for up to
      3 courses in the absence of disease progression or unacceptable toxicity. Patients then
      undergo surgery.

      EXPANSION PHASE: Patients receive single-agent nintedanib PO BID on days 1-28. Patients then
      receive 3 courses of induction chemotherapy and undergo surgery as above. Treatment continues
      even if patients experience disease progression, unless treatment is judged to be not in the
      best interest of the patient by the treating physician.

      After completion of study treatment, patients are followed up within 8 weeks and then
      periodically thereafter.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum tolerated dose (MTD) of nintedanib
time frame: 21 days
description: Will be determined according to incidence of dose-limiting toxicity as graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
measure: Major pathologic response rate, defined as less than or equal to 10% viable tumor cells in the resected specimen using the methods described by Pataer
time frame: Up to 5 years
description: Multivariate analysis will be used to explore the role of biomarkers in predicting pathologic response to treatment, in an exploratory way.
measure: Change in tumor size (Expansion phase)
time frame: Baseline to 4 weeks
description: Will be assessed by computed tomography (CT) after single-agent nintedanib.
measure: Response rate after single-agent nintedanib (Expansion phase)
time frame: Up to 4 weeks
description: Will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST).
arm group label: Treatment (cisplatin, docetaxel, nintedanib)
arm group type: Experimental
description: RUN-IN PHASE: Patients receive induction therapy comprising cisplatin IV over 2 hours on day 1, docetaxel IV over 1 hour on day 1, and nintedanib PO BID from day 2 of course 1 to day 7 of course 3. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
EXPANSION PHASE: Patients receive single-agent nintedanib PO BID on days 1-28. Patients then receive 3 courses of induction chemotherapy and undergo surgery as above. Treatment continues even if patients experience disease progression, unless treatment is judged to be not in the best interest of the patient by the treating physician.
intervention type: Drug
intervention name: Cisplatin
description: Given IV
arm group label: Treatment (cisplatin, docetaxel, nintedanib)
other name: Abiplatin
other name: Blastolem
other name: Briplatin
other name: CDDP
other name: Cis-diammine-dichloroplatinum
other name: Cis-diamminedichloridoplatinum
other name: Cis-diamminedichloro Platinum (II)
other name: Cis-diamminedichloroplatinum
other name: Cis-dichloroammine Platinum (II)
other name: Cis-platinous Diamine Dichloride
other name: Cis-platinum
other name: Cis-platinum II
other name: Cis-platinum II Diamine Dichloride
other name: Cismaplat
other name: Cisplatina
other name: Cisplatinum
other name: Cisplatyl
other name: Citoplatino
other name: Citosin
other name: Cysplatyna
other name: DDP
other name: Lederplatin
other name: Metaplatin
other name: Neoplatin
other name: Peyrone's Chloride
other name: Peyrone's Salt
other name: Placis
other name: Plastistil
other name: Platamine
other name: Platiblastin
other name: Platiblastin-S
other name: Platinex
other name: Platinol
other name: Platinol- AQ
other name: Platinol-AQ
other name: Platinol-AQ VHA Plus
other name: Platinoxan
other name: Platinum
other name: Platinum Diamminodichloride
other name: Platiran
other name: Platistin
other name: Platosin
intervention type: Drug
intervention name: Docetaxel
description: Given IV
arm group label: Treatment (cisplatin, docetaxel, nintedanib)
other name: Docecad
other name: RP56976
other name: Taxotere
other name: Taxotere Injection Concentrate
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Treatment (cisplatin, docetaxel, nintedanib)
intervention type: Drug
intervention name: Nintedanib
description: Given PO
arm group label: Treatment (cisplatin, docetaxel, nintedanib)
other name: BIBF 1120
other name: BIBF-1120
other name: Intedanib
other name: Multitargeted Tyrosine Kinase Inhibitor BIBF 1120
other name: tyrosine kinase inhibitor BIBF 1120
other name: Vargatef
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tina Cascone
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Cisplatin
mesh term: Docetaxel
mesh term: Nintedanib
mesh term: Tyrosine Protein Kinase Inhibitors