Trial record 2 of 24 for:    Master PD

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Southwest Oncology Group
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT02154490
First received: May 30, 2014
Last updated: August 2, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Recurrent Squamous Cell Lung Carcinoma
Stage IV Squamous Cell Lung Carcinoma
Drug: Docetaxel
Biological: Durvalumab
Drug: Erlotinib Hydrochloride
Drug: FGFR Inhibitor AZD4547
Biological: Ipilimumab
Other: Laboratory Biomarker Analysis
Biological: Nivolumab
Drug: Palbociclib
Biological: Rilotumumab
Drug: Taselisib
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-MAP)

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • IA-PFS as defined by RECIST 1.1 (Design #1, Phase II) [ Time Frame: From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 18 months since completion of accrual ] [ Designated as safety issue: No ]
    A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to IA-PFS, comparing the two treatment arms.

  • IA-PFS in patients with advanced stage refractory SCCA of the lung randomized to receive investigational therapy versus SoC (Design #2, Phase III) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median IA-PFS. A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to PFS comparing the two treatment arms at the levels specified.

  • Less than 33% improvement in median IA-PFS as defined as RECIST 1.1 (Design #1, Phase III) [ Time Frame: From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 18 months since completion of accrual ] [ Designated as safety issue: No ]
    A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to IA-PFS, comparing the two treatment arms. A Cox PH model will be used to estimate the hazard ratios and associated confidence intervals.

  • Objective Response Rate (ORR) (confirmed and unconfirmed, complete and partial) (Design #2, Phase II) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    The investigational therapy arm will be judged to have provided sufficient evidence to proceed to the Phase III component if the ORR is at least 25%. Response rates and associated confidence intervals will be calculated.

  • OS (Design #1, Phase III) [ Time Frame: From date of sub-study registration (or date of screening registration if patient never enrolls in a sub-study) to date of death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]
    A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to OS, comparing the two treatment arms. A Cox PH model will be used to estimate the hazard ratios and associated confidence intervals.

  • OS in patients with advanced stage refractory SCCA of the lung randomized to receive investigational therapy versus SoC (Design #2, Phase III) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    The Brookmeyer-Crowley method will be used to calculate confidence intervals for median OS. A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to OS comparing the two treatment arms at the levels specified.


Secondary Outcome Measures:
  • DoR among patients who achieve a CR or PR by RECIST 1.1 (Design #2, Phase II) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to calculate confidence intervals for median DoR.

  • Frequency and severity of toxicities associated with investigational therapy versus SoC (Design #2, Phase III) [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Analysis of toxicities will be performed using a chi-square or Fisher's exact test, as appropriate.

  • IA-PFS, censoring patients with symptomatic deterioration (SD) at the time of SD (Design #1, Phase III) [ Time Frame: From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]
  • OS with investigational therapy (Design #2, Phase II) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to OS comparing the two treatment arms at the levels specified. A Cox PH model will be used to estimate the hazard ratios and associated confidence intervals.

  • PFS with investigational therapy (Design #2, Phase II) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to PFS comparing the two treatment arms at the levels specified. A Cox PH model will be used to estimate the hazard ratios and associated confidence intervals.

  • Response rate (confirmed and unconfirmed) in patients with measurable disease as defined by RECIST 1.1 (Design #1, Phase II and III) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Analysis will be performed using a chi squared or Fisher's exact test, as appropriate. Response proportions will be compared using a 1-sided Fisher's exact test at the 0.001 level.

  • Response rates (confirmed and unconfirmed, complete and partial) among patients randomized to receive investigational therapy versus SoC (Design #2, Phase III) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Analysis of response rates will be performed using a chi-square or Fisher's exact test, as appropriate.

  • Severity of toxicities associated with investigational therapy versus SoC (Design #2, Phase II) [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Analysis of toxicities will be performed using a chi-square or Fisher's exact test, as appropriate.

  • Toxicity frequencies, monitored using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Design #1, Phase II and III) [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Analysis will be performed using a chi squared or Fisher's exact test, as appropriate.


Other Outcome Measures:
  • Screen success rate, monitored by the percentage of screened patients that register to a therapeutic sub-study [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Treatment arm randomization acceptance rate, monitored by the percentage of patients that receive at least one dose of the treatment they are randomized to (Design #1) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: June 2014
Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S1400A Arm I (MEDI4736) (CLOSED TO ACCRUAL 12/2015)
Patients with tumors that do not match one of the currently active drug-biomarker combinations randomized to Arm I receive anti-B7H1 monoclonal antibody MEDI4736 IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.
Biological: Durvalumab
Given IV
Other Names:
  • Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer
  • MEDI-4736
  • MEDI4736
Other: Laboratory Biomarker Analysis
Correlative studies
Active Comparator: S1400A Arm II (CLOSED TO ACCRUAL 4/2015)
Patients with tumors that do not match one of the currently active drug-biomarker combinations randomized to Arm II receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15)
Drug: Docetaxel
Given IV
Other Names:
  • Docecad
  • RP56976
  • Taxotere
  • Taxotere Injection Concentrate
Other: Laboratory Biomarker Analysis
Correlative studies
Experimental: S1400A Arm III (MEDI4736)
For patients assigned to Arm 1, MEDI4736: Upon evidence of progression following discontinuation of 12 months of treatment, patients may restart treatment with Arm 3, MEDI4736 for up to 12 months with the same treatment guidelines followed during the initial 12-month treatment period. Patients will only be able to restart treatment once; thus a maximum of two 12- month periods will be allowed. Patients registered to Arm III receive anti-B7H1 monoclonal antibody MEDI4736 IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.
Biological: Durvalumab
Given IV
Other Names:
  • Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer
  • MEDI-4736
  • MEDI4736
Other: Laboratory Biomarker Analysis
Correlative studies
Experimental: S1400B Arm I (taselisib)
Patients with tumors positive for PI3KCA randomized to Arm I receive taselisib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Taselisib
Given PO
Other Name: GDC-0032
Active Comparator: S1400B Arm II (CLOSED TO ACCRUAL 12/18/2015)
Patients with tumors positive for PI3KCA randomized to Arm II receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #3 12/18/2015)
Drug: Docetaxel
Given IV
Other Names:
  • Docecad
  • RP56976
  • Taxotere
  • Taxotere Injection Concentrate
Other: Laboratory Biomarker Analysis
Correlative studies
Experimental: S1400B Arm III (taselisib)
Re-Registration Treatment with GDC-0032 (Taselisib). Upon progression patients in Arm 2 may be eligible for Re-Registration to receive GDC-0032. Patients will receive taselisib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Taselisib
Given PO
Other Name: GDC-0032
Experimental: S1400C Arm I (palbociclib)
Patients with tumors positive for CDK4/6, CCND1, CCND2, and CCND3 randomized to Arm I receive palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Palbociclib
Given PO
Other Names:
  • Ibrance
  • PD-0332991
  • PD-332991
Active Comparator: S1400C Arm II (CLOSED TO ACCRUAL 12/18/2015)
Patients with tumors positive for CDK4, CCND1, CCND2, and CCND3 randomized to Arm II receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #3 12/18/2015)
Drug: Docetaxel
Given IV
Other Names:
  • Docecad
  • RP56976
  • Taxotere
  • Taxotere Injection Concentrate
Other: Laboratory Biomarker Analysis
Correlative studies
Experimental: S1400C Arm III (palbociclib)
Re-Registration Treatment with palbociclib. Upon progression patients in Arm 2 may be eligible for Re-Registration to receive palbociclib. Patients will receive palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Palbociclib
Given PO
Other Names:
  • Ibrance
  • PD-0332991
  • PD-332991
Experimental: S1400D Arm I (AZD4547)
Patients with tumors positive for FGFR1, FGFR2, and FGFR3 randomized to Arm I receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: FGFR Inhibitor AZD4547
Given PO
Other Name: AZD4547
Other: Laboratory Biomarker Analysis
Correlative studies
Active Comparator: S1400D Arm II (CLOSED TO ACCRUAL 12/18/2015)
Patients with tumors positive for FGFR1, FGFR2, and FGFR3 randomized to Arm II receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #3 12/18/2015)
Drug: Docetaxel
Given IV
Other Names:
  • Docecad
  • RP56976
  • Taxotere
  • Taxotere Injection Concentrate
Other: Laboratory Biomarker Analysis
Correlative studies
Experimental: S1400D Arm III (AZD4547)
Re-Registration Treatment with AZD4547. Upon progression patients in Arm 2 may be eligible for Re-Registration to receive AZD4547. Patients will receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: FGFR Inhibitor AZD4547
Given PO
Other Name: AZD4547
Other: Laboratory Biomarker Analysis
Correlative studies
Experimental: S1400E Arm I (CLOSED TO ACCRUAL 11/2014)
Patients with tumors positive for HGF/c-MET randomized to Arm I receive rilotumumab IV on day 1 and erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (permanently closed to accrual on 11/25/14)
Drug: Erlotinib Hydrochloride
Given PO
Other Names:
  • Cp-358,774
  • OSI-774
  • Tarceva
Other: Laboratory Biomarker Analysis
Correlative studies
Biological: Rilotumumab
Given IV
Other Names:
  • AMG 102
  • Anti-HGF Monoclonal Antibody AMG 102
  • Fully Human Anti-HGF Monoclonal Antibody AMG 102
Active Comparator: S1400E Arm II (CLOSED TO ACCRUAL 11/2014)
Patients with tumors positive for HGF/c-MET randomized to Arm II receive erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (permanently closed to accrual on 11/25/14)
Drug: Erlotinib Hydrochloride
Given PO
Other Names:
  • Cp-358,774
  • OSI-774
  • Tarceva
Other: Laboratory Biomarker Analysis
Correlative studies
Experimental: S1400I Arm I (nivolumab, ipilimumab)
Patients with tumors that do not match one of the currently active drug-biomarker combinations or did not meet the eligibility requirements for that bio-marker driven sub-study randomized to Arm I receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third cycle. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Biological: Ipilimumab
Given IV
Other Names:
  • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
  • BMS-734016
  • MDX-010
  • MDX-CTLA4
  • Yervoy
Other: Laboratory Biomarker Analysis
Correlative studies
Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • ONO-4538
  • Opdivo
Active Comparator: S1400I Arm II (nivolumab)
Patients with tumors that do not match one of the currently active drug-biomarker combinations or did not meet the eligibility requirements for that bio-marker driven sub-study randomized to Arm II receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studies
Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • ONO-4538
  • Opdivo

  Show Detailed Description

  Eligibility

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

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); at least one of these lines of therapy must have been a platinum-based chemotherapy regimen; patients must have progressed following the 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 disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy
    • Pre-screening prior to progression on current treatment: to be eligible for pre-screening, current treatment must be for stage IV 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; 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 and sign off on the S1400 Local Pathology Review Form prior to screening/pre-screening registration; patients must agree to have this tissue submitted to Foundation Medicine for common broad platform Clinical Laboratory Improvement Amendments (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 not have a known epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion
  • 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 per RECIST 1.1 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; localized palliative radiation therapy is allowed for symptom management, provided treatment is completed >= 14 days prior to sub-study registration; all other types of radiation must be completed >= 28 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 (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 1 day 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: 1) have undetectable viral load using standard HIV assays in clinical practice, 2) have cluster of differentiation (CD)4 count >= 400/mcL, 3) not require prophylaxis for any opportunistic infections (i.e., fungal, Mycobacterium avium complex [mAC], or pneumocystis jiroveci pneumonia [PCP] prophylaxis), and 4) 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02154490

  Show 783 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Vassiliki Papadimitrakopoulou Southwest Oncology Group
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT02154490     History of Changes
Other Study ID Numbers: S1400  NCI-2014-00627  S1400E  S1400A  S1400I  S1400C  S1400D  S1400B  S1400  S1400  U10CA180888 
Study First Received: May 30, 2014
Last Updated: August 2, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Nivolumab
Palbociclib
Erlotinib Hydrochloride
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunoglobulin G
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 30, 2016