Clinical trial NCT02662634: A Safety and Feasibility Study of AGS-003-LNG for the Treatment of Stage 3 Non Small Cell Lung Cancer
Official title: A Safety and Feasibility Study of AGS-003-LNG for the Treatment of Stage 3 Non Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: NSCLC
resectable
non-small cell lung cancer
immunotherapy
autologous
dendritic cell
Lead sponsor: GU Research Network, LLC
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety - Adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) V4.03
timeFrame: 2 Years
measure: Immunogenicity - Generation of Cluster of Differentiation-8 (CD8)+ Cluster of Differentiation (CD28)+ memory T-cells
timeFrame: After 5th dose of AGS-003-LNG. Within 6 months.
Secondary outcomes:
measure: Efficacy - Overall survival
timeFrame: 2 Years
measure: Efficacy - Progression-free survival as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
timeFrame: 2 Years
measure: Efficacy - Objective response rate. The number of patients with a Complete Response or Partial Response.
timeFrame: 2 Years
measure: Feasibility - Number of patients with a success in the manufacture of AGS-003-LNG.
timeFrame: 1 Month
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Cancer Research Network of Nebraska / Oncology Associates
state: Nebraska
Study officials:
affiliation: Cancer Research Network of Nebraska
name: Luke T Nordquist, MD
role: STUDY_DIRECTOR
References: