Non-small Cell Lung Cancer (NSCLC)Phase 2NCT02662634
A Safety and Feasibility Study of AGS-003-LNG for the Treatment of Stage 3 Non Small Cell Lung Cancer
A Phase 2 study testing AGS-003-LNG, Carboplatin and Abraxane in people with Non-small Cell Lung Cancer (NSCLC), run by GU Research Network, LLC at 1 site in United States.
Trial summary
Feasibility and Safety study of autologous dendritic cell immunotherapy (AGS-003-LNG) in patients with resectable non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- AGS-003-LNG, Carboplatin and Abraxane
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Mar 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years.
- 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.
- Stage III (T1-3, N1-2, M0) of any histology.
- Scheduled for routine lobectomy, mediastinoscopy, wedge resection, thoracotomy or VATS procedures.
- 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:
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- Successful RNA isolation and amplification from tumor sample (as determined by Argos).
- Karnofsky performance status (KPS) score of 80-100.
- Life expectancy of six months or greater.
- NSCLC of any histology.
- 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.
- 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.
- Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- 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.
Who cannot join
- Active autoimmune disease or condition requiring chronic immunosuppressive therapy
- Any clinically significant condition that prohibits the initiation of standard of care.
- 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.
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- non-metastatic prostate cancer with a normal prostate-specific antigen (PSA) level.
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease.
- Clinically significant disorders or conditions including
- cardiovascular system.
- renal system.
- hepatic organ system.
- coagulation disorders.
- Clinically significant infections, including human immunodeficiency virus (HIV), syphilis, and active hepatitis B or C.
- Pregnant or breastfeeding.
- Any serious medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Research Network of Nebraska / Oncology Associates
Omaha, Nebraska, 68118
About this study
Feasibility and Safety study of autologous dendritic cell immunotherapy (AGS-003-LNG) in patients with resectable non-small cell lung cancer.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- AGS-003-LNG, Carboplatin, Abraxane, Alimta, Cisplatin
- Keywords
- NSCLC, resectable, non-small cell lung cancer, immunotherapy, autologous, dendritic cell
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGS-003-LNGBiological
autologous dendritic cell immunotherapy
CarboplatinDrug
Also called Paraplatin
Carboplatin is an anticancer drug ("antineoplastic" or "cytotoxic") chemotherapy drug. Carboplatin is classified as an "alkylating agent."
AbraxaneDrug
Also called Protein-bound paclitaxel, nano-particle albumin-bound paclitaxel, nab-paclitaxel
Paclitaxel destroys cancer cells by preventing the normal breakdown of microtubules during cell division.
AlimtaDrug
Also called Pemetrexed
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
CisplatinDrug
Also called Cisplatinum, platamin, neoplatin, cismaplat
Binds to and causes crosslinking of DNA, which ultimately triggers apoptosis
TaxolDrug
Also called Paclitaxel
Mechanism of action involves interference with the normal breakdown of microtubules during cell division.
Radiation TherapyRadiation
Causes DNA strand breaks.
| Study group | Role | What they receive |
|---|---|---|
| Sequential, no radiation | Experimental | 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). Receives: Biological: AGS-003-LNG; Drug: Carboplatin; Drug: Abraxane; Drug: Alimta; Drug: Cisplatin; Drug: Taxol; Radiation: Radiation Therapy |
| Concurrent, no radiation | Experimental | 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). Receives: Biological: AGS-003-LNG; Drug: Carboplatin; Drug: Abraxane; Drug: Alimta; Drug: Cisplatin; Drug: Taxol; Radiation: Radiation Therapy |
| Sequential, radiation | Experimental | 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 Receives: Biological: AGS-003-LNG; Drug: Carboplatin; Drug: Abraxane; Drug: Alimta; Drug: Cisplatin; Drug: Taxol; Radiation: Radiation Therapy |
| Concurrent, radiation | Experimental | 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. Receives: Biological: AGS-003-LNG; Drug: Carboplatin; Drug: Abraxane; Drug: Alimta; Drug: Cisplatin; Drug: Taxol; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After 5th dose of AGS-003-LNG. Within 6 months.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GU Research Network, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luke T Nordquist, MD, Study director, Cancer Research Network of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662634
- Sponsor's protocol ID
- AGS-003-024
- Status last verified
- Mar 2016
- First submitted
- 12 Jan 2016
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Feasibility Study of AGS-003-LNG for the Treatment of Stage 3 Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02662634
- Acronym / sponsor ID
- AGS-003-024
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- NSCLC, resectable, non-small cell lung cancer, immunotherapy, autologous, dendritic cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GU Research Network, LLCUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequential, no radiation | Experimental | Biological: AGS-003-LNG, Drug: Carboplatin, Drug: Abraxane, Drug: Alimta, Drug: Cisplatin, Drug: Taxol, Radiation: Radiation TherapyAGS-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 | Experimental | Biological: AGS-003-LNG, Drug: Carboplatin, Drug: Abraxane, Drug: Alimta, Drug: Cisplatin, Drug: Taxol, Radiation: Radiation TherapyAGS-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 | Experimental | Biological: AGS-003-LNG, Drug: Carboplatin, Drug: Abraxane, Drug: Alimta, Drug: Cisplatin, Drug: Taxol, Radiation: Radiation TherapyAGS-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 | Experimental | Biological: AGS-003-LNG, Drug: Carboplatin, Drug: Abraxane, Drug: Alimta, Drug: Cisplatin, Drug: Taxol, Radiation: Radiation TherapyAGS-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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 19 years.
- 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.
- Stage III (T1-3, N1-2, M0) of any histology.
- Scheduled for routine lobectomy, mediastinoscopy, wedge resection, thoracotomy or VATS procedures.
- Signed and dated informed consent document for study participation.
Key exclusion criteria (16 listed)
- Active autoimmune disease or condition requiring chronic immunosuppressive therapy
- Any clinically significant condition that prohibits the initiation of standard of care.
- Malignancies within the prior three years, except for:
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease.
- Clinically significant disorders or conditions including
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGS-003-LNGautologous dendritic cell immunotherapy | Biological | Concurrent, no radiation, Concurrent, radiation, Sequential, no radiation, Sequential, radiation |
| CarboplatinAlso: ParaplatinCarboplatin is an anticancer drug ("antineoplastic" or "cytotoxic") chemotherapy drug. Carboplatin is classified as an "alkylating agent." | Drug | Concurrent, no radiation, Concurrent, radiation, Sequential, no radiation, Sequential, radiation |
| AbraxaneAlso: Protein-bound paclitaxel, nano-particle albumin-bound paclitaxel, nab-paclitaxelPaclitaxel destroys cancer cells by preventing the normal breakdown of microtubules during cell division. | Drug | Concurrent, no radiation, Concurrent, radiation, Sequential, no radiation, Sequential, radiation |
| AlimtaAlso: PemetrexedBy 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 | Drug | Concurrent, no radiation, Concurrent, radiation, Sequential, no radiation, Sequential, radiation |
| CisplatinAlso: Cisplatinum, platamin, neoplatin, cismaplatBinds to and causes crosslinking of DNA, which ultimately triggers apoptosis | Drug | Concurrent, no radiation, Concurrent, radiation, Sequential, no radiation, Sequential, radiation |
| TaxolAlso: PaclitaxelMechanism of action involves interference with the normal breakdown of microtubules during cell division. | Drug | Concurrent, no radiation, Concurrent, radiation, Sequential, no radiation, Sequential, radiation |
| Radiation TherapyCauses DNA strand breaks. | Radiation | Concurrent, no radiation, Concurrent, radiation, Sequential, no radiation, Sequential, radiation |
Primary outcome
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.
4 secondary outcomes
Efficacy - Overall survival
Time frame: 2 Years
Efficacy - Progression-free survival as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Time frame: 2 Years
Efficacy - Objective response rate. The number of patients with a Complete Response or Partial Response.
Time frame: 2 Years
Feasibility - Number of patients with a success in the manufacture of AGS-003-LNG.
Time frame: 1 Month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luke T Nordquist, MD study director
Cancer Research Network of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AGS-003-LNG, Carboplatin and Abraxane in people with Non-small Cell Lung Cancer (NSCLC), run by GU Research Network, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) V4.03 (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.