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

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02662634
• Other study ID #: AGS-003-024
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: March 2018

Study information

• Verified date: March 2016
• Source: GU Research Network, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Feasibility and Safety study of autologous dendritic cell immunotherapy (AGS-003-LNG) in patients with resectable non-small cell lung cancer.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)

Intervention

Biological:
• AGS-003-LNG
autologous dendritic cell immunotherapy

Drug:
• Carboplatin
Carboplatin is an anticancer drug ("antineoplastic" or "cytotoxic") chemotherapy drug. Carboplatin is classified as an "alkylating agent."
• Abraxane
Paclitaxel destroys cancer cells by preventing the normal breakdown of microtubules during cell division.
• Alimta
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
• Cisplatin
Binds to and causes crosslinking of DNA, which ultimately triggers apoptosis
• Taxol
Mechanism of action involves interference with the normal breakdown of microtubules during cell division.

Radiation:
• Radiation Therapy
Causes DNA strand breaks.

Locations

Country	Name	City	State
United States	Cancer Research Network of Nebraska / Oncology Associates	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
GU Research Network, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 Years
Primary	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.	After 5th dose of AGS-003-LNG. Within 6 months.
Secondary	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.	2 Years
Secondary	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.	2 Years
Secondary	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.	2 Years
Secondary	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.	1 Month