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A Safety and Feasibility Study of AGS-003-LNG for the Treatment of Stage 3 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: NCT02662634
Recruitment Status : Withdrawn
First Posted : January 25, 2016
Last Update Posted : July 22, 2020
Sponsor:
Collaborator:
Cancer Research Network of Nebraska/Oncology Associates
Information provided by (Responsible Party):
GU Research Network, LLC

Tracking Information
First Submitted Date  ICMJE January 12, 2016
First Posted Date  ICMJE January 25, 2016
Last Update Posted Date July 22, 2020
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2016)
  • Safety - Adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) V4.03 [ Time Frame: 2 Years ]
    Safety of AGS-003-LNG for subjects who receive 1 or more doses of AGS-003-LNG in combination with standard platinum-doublet chemotherapy with or without radiation. Adverse events will be collected per CTCAE V4.03.
  • Immunogenicity - Generation of Cluster of Differentiation-8 (CD8)+ Cluster of Differentiation (CD28)+ memory T-cells [ Time Frame: After 5th dose of AGS-003-LNG. Within 6 months. ]
    Generation of CD8+CD28+ memory T-cells against tumor associated antigens in subject receiving 5 or more doses of AGS-003-LNG.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2016)
  • Efficacy - Overall survival [ Time Frame: 2 Years ]
    While the study is not powered for efficacy Overall Survival (including median and one year survival) be analyzed as an exploratory endpoints.
  • Efficacy - Progression-free survival as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. [ Time Frame: 2 Years ]
    While the study is not powered for efficacy, Progression Free Survival will be analyzed as an exploratory endpoint.
  • Efficacy - Objective response rate. The number of patients with a Complete Response or Partial Response. [ Time Frame: 2 Years ]
    While the study is not powered for efficacy Objective Response Rate will be analyzed as an exploratory endpoint.
  • Feasibility - Number of patients with a success in the manufacture of AGS-003-LNG. [ Time Frame: 1 Month ]
    AGS-003-LNG manufacturing success rate for non small cell lung cancer tumor RNA isolation from surgical resection.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Feasibility Study of AGS-003-LNG for the Treatment of Stage 3 Non Small Cell Lung Cancer
Official Title  ICMJE A Safety and Feasibility Study of AGS-003-LNG for the Treatment of Stage 3 Non Small Cell Lung Cancer
Brief Summary Feasibility and Safety study of autologous dendritic cell immunotherapy (AGS-003-LNG) in patients with resectable non-small cell lung cancer.
Detailed Description Feasibility and Safety study of autologous dendritic cell immunotherapy (AGS-003-LNG) in patients with resectable non-small cell lung cancer. Non-small cell lung cancer tumor will be resected from the patient. RNA from the tumor will be amplified and subsequently electroporated into matured, autologous dendritic cells. The dendritic cells with tumor RNA will be dosed back to the patient. Study will investigate feasibility and safety.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer (NSCLC)
Intervention  ICMJE
  • Biological: AGS-003-LNG
    autologous dendritic cell immunotherapy
  • Drug: Carboplatin
    Carboplatin is an anticancer drug ("antineoplastic" or "cytotoxic") chemotherapy drug. Carboplatin is classified as an "alkylating agent."
    Other Name: Paraplatin
  • Drug: Abraxane
    Paclitaxel destroys cancer cells by preventing the normal breakdown of microtubules during cell division.
    Other Names:
    • Protein-bound paclitaxel
    • nano-particle albumin-bound paclitaxel
    • nab-paclitaxel
  • Drug: Alimta
    By inhibiting the formation of precursor purine and pyrimidine nucleotides, pemetrexed prevents the formation of DNA and RNA, which are required for the growth and survival of both normal cells and cancer cell
    Other Name: Pemetrexed
  • Drug: Cisplatin
    Binds to and causes crosslinking of DNA, which ultimately triggers apoptosis
    Other Names:
    • Cisplatinum
    • platamin
    • neoplatin
    • cismaplat
    • cis-diamminedichloroplatinum(II)
  • Drug: Taxol
    Mechanism of action involves interference with the normal breakdown of microtubules during cell division.
    Other Name: Paclitaxel
  • Radiation: Radiation Therapy
    Causes DNA strand breaks.
Study Arms  ICMJE
  • Experimental: Sequential, no radiation

    AGS-003-LNG initiated after completion of platinum doublet chemotherapy. AGS-003-LNG induction = 1 dose administered every 3 weeks for 5 doses. Booster doses will then be administered every 12 weeks. A dose of AGS-003-LNG consists of (1.2 x 10-7 Dendritic cells.) Platinum-doublet chemotherapy can be any of the following determined by PI

    Carboplatin/Abraxane:

    ABRAXANE is 100 mg/m2 i.v. over 30 minutes on Days 1, 8, & 15 of each 21-day cycle; carboplatin Area Under Curve (AUC) 6 (C&G) on Day 1 of each 21-day cycle immediately after ABRAXANE.

    Carboplatin/Alimta ALIMTA is 500 mg/m2 i.v. on Day 1 of each 21-day cycle in combination with carboplatin AUC 6 (C&G) i.v. 30 minutes after ALIMTA.

    Cisplatin/Alimta ALIMTA is 500 mg/m2 i.v. on Day 1 of each 21-day with cisplatin 75 mg/m2 i.v., 30 minutes after ALIMTA.

    Carboplatin/Taxol TAXOL administered i.v. over 24 hrs at a dose of 135 mg/m2 followed by carboplatin, AUC 6 (C&G).

    Interventions:
    • Biological: AGS-003-LNG
    • Drug: Carboplatin
    • Drug: Abraxane
    • Drug: Alimta
    • Drug: Cisplatin
    • Drug: Taxol
    • Radiation: Radiation Therapy
  • Experimental: Concurrent, no radiation

    AGS-003-LNG dosing initiated concurrently or subsequent to 3rd cycle of platinum doublet chemotherapy & radiation therapy. AGS-003-LNG induction = 1 dose administered every 3 wks for 5 doses. Booster doses will then be administered every 12 wks. A dose of AGS-003-LNG =1.2 x 10-7 Dendritic cells.

    Platinum-doublet chemotherapy can be any of the following determined by PI

    Carboplatin/Abraxane:

    ABRAXANE is 100 mg/m2 i.v. over 30 minutes on Days 1, 8, & 15 of each 21-day cycle; carboplatin AUC 6 (C&G) on Day 1 of each 21-day cycle immediately after ABRAXANE.

    Carboplatin/Alimta ALIMTA is 500 mg/m2 i.v. on Day 1 of each 21-day cycle in combination with carboplatin AUC 6 (C&G) i.v. 30 minutes after ALIMTA.

    Cisplatin/Alimta ALIMTA is 500 mg/m2 i.v. on Day 1 of each 21-day with cisplatin 75 mg/m2 i.v., 30 minutes after ALIMTA.

    Carboplatin/Taxol TAXOL administered i.v. over 24 hrs at a dose of 135 mg/m2 followed by carboplatin, AUC 6 (C&G).

    Interventions:
    • Biological: AGS-003-LNG
    • Drug: Carboplatin
    • Drug: Abraxane
    • Drug: Alimta
    • Drug: Cisplatin
    • Drug: Taxol
    • Radiation: Radiation Therapy
  • Experimental: Sequential, radiation

    AGS-003-LNG initiated after completion of platinum doublet chemotherapy. AGS-003-LNG induction = 1 dose administered every 3 weeks for 5 doses. Booster doses will then be administered every 12 weeks. A dose of AGS-003-LNG consists of (1.2 x 10-7 Dendritic cells.) Platinum-doublet chemotherapy can be any of the following determined by PI

    Carboplatin/Abraxane:

    ABRAXANE is 100 mg/m2 i.v. over 30 minutes on Days 1, 8, & 15 of each 21-day cycle; carboplatin AUC 6 (C&G) on Day 1 of each 21-day cycle immediately after ABRAXANE.

    Carboplatin/Alimta ALIMTA is 500 mg/m2 i.v. on Day 1 of each 21-day cycle in combination with carboplatin AUC 6 (C&G) i.v. 30 minutes after ALIMTA.

    Cisplatin/Alimta ALIMTA is 500 mg/m2 i.v. on Day 1 of each 21-day with cisplatin 75 mg/m2 i.v., 30 minutes after ALIMTA.

    Carboplatin/Taxol TAXOL administered i.v. over 24 hrs at a dose of 135 mg/m2 followed by carboplatin, AUC 6 (C&G).

    Radiation therapy per PI

    Interventions:
    • Biological: AGS-003-LNG
    • Drug: Carboplatin
    • Drug: Abraxane
    • Drug: Alimta
    • Drug: Cisplatin
    • Drug: Taxol
    • Radiation: Radiation Therapy
  • Experimental: Concurrent, radiation

    AGS-003-LNG dosing initiated concurrently during or subsequent to the 3rd cycle (3-week cycle) of platinum doublet chemotherapy & radiation therapy. AGS-003-LNG induction = 1 dose administered every 3 wks for 5 doses. Booster doses administered every 12 wks. A dose of AGS-003-LNG =1.2 x 10-7 Dendritic cells.

    Platinum-doublet chemotherapy choice of the following determined by PI

    Carboplatin/Abraxane:

    ABRAXANE is 100 mg/m2 i.v. over 30 minutes on Days 1, 8, & 15 of each 21-day cycle; carboplatin AUC 6 (C&G) on Day 1 of each 21-day cycle immediately after ABRAXANE.

    Carboplatin/Alimta ALIMTA is 500 mg/m2 i.v. on Day 1 of each 21-day cycle in combination with carboplatin AUC 6 (C&G) i.v. 30 minutes after ALIMTA.

    Cisplatin/Alimta ALIMTA is 500 mg/m2 i.v. on Day 1 of each 21-day with cisplatin 75 mg/m2 i.v., 30 minutes after ALIMTA.

    Carboplatin/Taxol TAXOL administered i.v. over 24 hrs at a dose of 135 mg/m2 followed by carboplatin, AUC 6 (C&G).

    Radiation therapy per PI.

    Interventions:
    • Biological: AGS-003-LNG
    • Drug: Carboplatin
    • Drug: Abraxane
    • Drug: Alimta
    • Drug: Cisplatin
    • Drug: Taxol
    • Radiation: Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 20, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2016)
20
Estimated Study Completion Date  ICMJE March 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 19 years.
  2. Newly diagnosed non-small cell lung cancer indicated for routine lobectomy, mediastinoscopy, wedge resection, thoracotomy or Video-assisted thoracoscopic surgery (VATS) procedures with tumor collection.
  3. Stage III (T1-3, N1-2, M0) of any histology.
  4. Scheduled for routine lobectomy, mediastinoscopy, wedge resection, thoracotomy or VATS procedures.
  5. Signed and dated informed consent document for study participation.

After tumor collection, potential subjects must meet all the following criteria to be enrolled in study treatment:

  1. Successful RNA isolation and amplification from tumor sample (as determined by Argos).
  2. Karnofsky performance status (KPS) score of 80-100.
  3. Life expectancy of six months or greater.
  4. NSCLC of any histology.
  5. Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to Grade ≤ 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
  6. Negative serum pregnancy test for female subjects with reproductive potential, and agreement of all male and female subjects of reproductive potential to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug.
  7. Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study.
  8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
  9. Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.

Exclusion Criteria:

  1. Active autoimmune disease or condition requiring chronic immunosuppressive therapy
  2. Any clinically significant condition that prohibits the initiation of standard of care.
  3. Malignancies within the prior three years, except for:

    • treated in situ carcinomas or non-melanoma skin cancer.
    • adequately treated early stage breast cancer.
    • superficial bladder cancer.
    • non-metastatic prostate cancer with a normal prostate-specific antigen (PSA) level.
  4. History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease.
  5. Clinically significant disorders or conditions including

    • cardiovascular system.
    • renal system.
    • hepatic organ system.
    • coagulation disorders.
  6. Clinically significant infections, including human immunodeficiency virus (HIV), syphilis, and active hepatitis B or C.
  7. Pregnant or breastfeeding.
  8. Any serious medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02662634
Other Study ID Numbers  ICMJE AGS-003-024
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party GU Research Network, LLC
Study Sponsor  ICMJE GU Research Network, LLC
Collaborators  ICMJE Cancer Research Network of Nebraska/Oncology Associates
Investigators  ICMJE
Study Director: Luke T Nordquist, MD Cancer Research Network of Nebraska
PRS Account GU Research Network, LLC
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP