A Safety and Feasibility Study of AGS-003-LNG for the Treatment of Stage 3 Non Small Cell Lung Cancer

Phase 2

Withdrawn

• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Interventions: Biological: AGS-003-LNG; Drug: Carboplatin; Drug: Abraxane; Drug: Alimta; Drug: Cisplatin; Drug: Taxol; Radiation: Radiation Therapy

• Registration Number: NCT02662634
• Lead Sponsor: GU Research Network, LLC

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 Timeline

• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-25
• Status Verified: 2016-03
• Study Start: 2016-03
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concurrent, no radiation	Abraxane	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).
Concurrent, radiation	Alimta	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.
Sequential, no radiation	AGS-003-LNG	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).
Sequential, no radiation	Alimta	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).
Sequential, radiation	Abraxane	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
Sequential, no radiation	Abraxane	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).
Concurrent, no radiation	AGS-003-LNG	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).
Concurrent, no radiation	Alimta	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).
Sequential, no radiation	Radiation Therapy	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).
Concurrent, no radiation	Radiation Therapy	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).
Sequential, radiation	AGS-003-LNG	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
Concurrent, radiation	Abraxane	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.
Sequential, radiation	Radiation Therapy	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
Concurrent, radiation	AGS-003-LNG	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.
Sequential, radiation	Alimta	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
Concurrent, radiation	Cisplatin	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.
Concurrent, radiation	Radiation Therapy	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.
Sequential, no radiation	Carboplatin	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).
Sequential, no radiation	Taxol	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).
Sequential, no radiation	Cisplatin	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).
Concurrent, no radiation	Carboplatin	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).
Concurrent, no radiation	Cisplatin	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).
Sequential, radiation	Carboplatin	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
Concurrent, no radiation	Taxol	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).
Sequential, radiation	Cisplatin	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
Sequential, radiation	Taxol	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
Concurrent, radiation	Carboplatin	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.
Concurrent, radiation	Taxol	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.

Primary Outcome Measures

Name	Time	Method
Immunogenicity - Generation of Cluster of Differentiation-8 (CD8)+ Cluster of Differentiation (CD28)+ memory T-cells	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.
Safety - Adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) V4.03	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.

Secondary Outcome Measures

Name	Time	Method
Efficacy - Overall survival	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.	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.	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.	1 Month	AGS-003-LNG manufacturing success rate for non small cell lung cancer tumor RNA isolation from surgical resection.

Trial Locations

Locations (1)

Cancer Research Network of Nebraska / Oncology Associates; 🇺🇸 Omaha, Nebraska, United States