A Phase 2 interventional study of AGS-003-LNG and Carboplatin in Non-small Cell Lung Cancer (NSCLC), sponsored by GU Research Network, LLC. Withdrawn at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-03-18.
Sponsored by GU Research Network, LLC · Phase 2, Interventional, and Treatment
Feasibility and Safety study of autologous dendritic cell immunotherapy (AGS-003-LNG) in patients with resectable 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. 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.
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After tumor collection, potential subjects must meet all the following criteria to be enrolled in study treatment:
Exclusion Criteria:
Malignancies within the prior three years, except for:
Clinically significant disorders or conditions including
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).
Biological: AGS-003-LNG · Drug: Carboplatin · Drug: Abraxane · Drug: Alimta · Drug: Cisplatin · Drug: Taxol · 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).
Biological: AGS-003-LNG · Drug: Carboplatin · Drug: Abraxane · Drug: Alimta · Drug: Cisplatin · Drug: Taxol · 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
Biological: AGS-003-LNG · Drug: Carboplatin · Drug: Abraxane · Drug: Alimta · Drug: Cisplatin · Drug: Taxol · 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.
Biological: AGS-003-LNG · Drug: Carboplatin · Drug: Abraxane · Drug: Alimta · Drug: Cisplatin · Drug: Taxol · Radiation: Radiation Therapy
autologous dendritic cell immunotherapy
Carboplatin is an anticancer drug ("antineoplastic" or "cytotoxic") chemotherapy drug. Carboplatin is classified as an "alkylating agent."
Also known as: Paraplatin
Paclitaxel destroys cancer cells by preventing the normal breakdown of microtubules during cell division.
Also known as: Protein-bound paclitaxel, nano-particle albumin-bound paclitaxel, nab-paclitaxel
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
Also known as: Pemetrexed
Binds to and causes crosslinking of DNA, which ultimately triggers apoptosis
Also known as: Cisplatinum, platamin, neoplatin, cismaplat, cis-diamminedichloroplatinum(II)
Mechanism of action involves interference with the normal breakdown of microtubules during cell division.
Also known as: Paclitaxel
Causes DNA strand breaks.
Safety - Adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) V4.03
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.
Time frame: 2 Years
Immunogenicity - Generation of Cluster of Differentiation-8 (CD8)+ Cluster of Differentiation (CD28)+ memory T-cells
Generation of CD8+CD28+ memory T-cells against tumor associated antigens in subject receiving 5 or more doses of AGS-003-LNG.
Time frame: After 5th dose of AGS-003-LNG. Within 6 months.
Efficacy - Overall survival
While the study is not powered for efficacy Overall Survival (including median and one year survival) be analyzed as an exploratory endpoints.
Time frame: 2 Years
Efficacy - Progression-free survival as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
While the study is not powered for efficacy, Progression Free Survival will be analyzed as an exploratory endpoint.
Time frame: 2 Years
Efficacy - Objective response rate. The number of patients with a Complete Response or Partial Response.
While the study is not powered for efficacy Objective Response Rate will be analyzed as an exploratory endpoint.
Time frame: 2 Years
Feasibility - Number of patients with a success in the manufacture of AGS-003-LNG.
AGS-003-LNG manufacturing success rate for non small cell lung cancer tumor RNA isolation from surgical resection.
Time frame: 1 Month
Plan to share: No
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This study is withdrawn, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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