A Safety and Feasibility Study of AGS-003-LNG for the Treatment of Stage 3 Non Small Cell Lung Cancer
Feasibility and Safety study of autologous dendritic cell immunotherapy (AGS-003-LNG) in patients with resectable non-small cell lung cancer.
Checked against the public recordLast updated Mar 18, 2022 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- GU Research Network, LLC
- Interventions being studied
- Biological: AGS-003-LNG; Drug: Carboplatin; Drug: Abraxane; Drug: Alimta; Drug: Cisplatin; Drug: Taxol; Radiation: Radiation Therapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Cancer Research Network of Nebraska / Oncology AssociatesOmaha, Nebraska
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 18, 2022. Always confirm current availability with the study team.