Immunotherapy Study in Progressive or Relapsed Non-Small Cell Lung Cancer
An Open-label, Randomized Phase IIB/III Active Control Study of Second-line Tergenpumatucel-L (Hyper-Acute(R)-Lung ) Immunotherapy Versus Docetaxel in Progressive or Relapsed Non-Small Cell Lung Cancer
2 other identifiers
interventional
135
1 country
24
Brief Summary
The purpose of this study is to assess overall survival of anti-tumor immunization using HyperAcute®-Lung immunotherapy versus Docetaxel in patients with progressed or relapsed non-small cell lung cancer (NSCLC) that have been previously treated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Feb 2013
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2013
CompletedFirst Posted
Study publicly available on registry
January 24, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2016
CompletedMay 28, 2020
May 1, 2020
3.3 years
January 7, 2013
May 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
The primary objective in Phase IIB and Phase III is to assess overall survival of anti-tumor immunization using HyperAcute®-Lung (HAL) Immunotherapy versus docetaxel in patients with progressed or relapsed non-small cell lung cancer (NSCLC) that have been previously treated.
Approximately 19 months, assuming a 24 month enrollment.
Secondary Outcomes (3)
Dosing schedule
Approximately 19 months, assuming a 24 month enrollment.
Tumor response rate
Approximately 19 months, assuming a 24 month enrollment.
Immunologic Response
Approximately 19 months, assuming a 24 month enrollment.
Study Arms (3)
Arm 1: Docetaxel
ACTIVE COMPARATORArm 1: Docetaxel 75 mg/m\^2 IV given every 3 weeks x 4 doses. If response or stable: Observe until disease progression. First Progression: Gemcitabine 1250 mg/m\^2/week for 2 weeks with 1 week rest or Pemetrexed 500 mg/m\^2 every 3 weeks until disease progression or significant toxicity.
Arm 2a: HyperAcute®-Lung Immunotherapy (weekly)
EXPERIMENTALArm 2a: 300 Million HAL cells given by intradermal injection weekly for 11 weeks and then every 2 months for 5 additional doses. Up to 16 total immunizations of 300 million immunotherapy cells until disease progression or toxicity. First Progression: Docetaxel 75 mg/m\^2 IV given every 3 weeks or Gemcitabine 1250 mg/m\^2 for 2 weeks with 1 week rest or Pemetrexed 500 mg/m\^2 every 3 weeks until disease progression or significant toxicity and continue with HAL administration given every 2 weeks (not to exceed 16 total immunizations).
Arm 2b: HyperAcute®-Lung Immunotherapy (biweekly)
EXPERIMENTALArm 2b: 300 Million HAL cells given by intradermal injection biweekly for 6 doses and then every month for 10 additional doses. Up to 16 total immunizations of 300 million immunotherapy cells until disease progression or toxicity. First Progression: Docetaxel 75 mg/m\^2 IV given every 3 weeks or Gemcitabine 1250 mg/m\^2 for 2 weeks with 1 week rest or Pemetrexed 500 mg/m\^2 every 3 weeks until disease progression or significant toxicity and continue with HAL administration given every 2 weeks (not to exceed 16 total immunizations).
Interventions
Docetaxel given in Arm 1 prior to first progression on study. Given as an option of salvage therapy after first progression on study for Arms 2a and 2b.
HAL-1, HAL-2 and HAL-3 immunotherapy components. Up to 16 immunizations of 300 million immunotherapy cells.
Given as an option of salvage therapy after first progression on study for Arms 1, 2a and 2b.
Given as an option of salvage therapy after first progression on study for Arms 1, 2a and 2b.
Eligibility Criteria
You may qualify if:
- Histological diagnosis of non-small cell lung cancer (NSCLC). Squamous cell (epidermoid), adenocarcinoma, bronchoalveolar carcinoma, and large cell anaplastic lung carcinoma histologies are eligible as are mixed histologies of NSCLC (i.e., adenosquamous). Mixed NSCLC/small cell lung carcinoma (SCLC), and variant large and small cell lung cancer are not eligible.
- Stage IIIB (AJCC Stage IIIB - Any T,N3M0 or T4N2M0) or Metastatic (AJCC Stage IV- any T, any N, M1), progressive, recurrent or refractory NSCLC. Patients may not be eligible for other curative intent treatment (e.g., surgical resection).
- For the purpose of eligibility for this trial, the above-cited disease states are defined as follows:
- Progressive NSCLC: Defined as increasing measurable disease, or the appearance of new measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria despite treatment.
- Recurrent NSCLC: Defined as the re-appearance of measurable disease, or the appearance of new measurable disease by RECIST Criteria after prior successful treatment or complete response.
- Refractory NSCLC: Defined as achieving less than a complete response and having residual measurable disease by RECIST criteria after prior treatment with chemotherapy, targeted or small molecules, monoclonal antibodies or any combination of these.
- Eastern Cooperative Oncology Group (ECOG)Performance Status ≤ 1.
- Serum albumin ≥3.0 gm/dL.
- Expected survival ≥4 months.
- Adequate organ function including:
- Marrow: Hemoglobin ≥10.0 dm/dL, absolute granulocyte count (AGC)≥1,000/mm\^3, platelets ≥100,000/mm\^3, absolute lymphocyte count ≥1000/mm\^3.
- Hepatic: Serum total bilirubin ≤1.5 x upper limit of normal (ULN) with the exception of \<2.9 mg/dL for patients with Gilbert's disease, alanine aminotransferase (ALT/SGPT) and aspartate aminotransferase (AST/SGOT) ≤2.5 x ULN.
- Renal: Serum creatinine (sCr) ≤1.5 x upper limit of normal, or creatinine clearance (Ccr) ≥50 mL/min.
- Measurable disease as defined by RECIST Criteria.
- Prior therapy for NSCLC that may include surgery, radiation therapy, immunotherapy and/or ≤ 2 prior chemotherapy regimens (such as neoadjuvant/adjuvant treatment), however only 1 chemotherapy regimen in the metastatic setting is allowed.
- +5 more criteria
You may not qualify if:
- Age \< 18-years-old.
- Active central nervous system (CNS) disease, metastases or carcinomatous meningitis. Patients with CNS metastases must be at least 2 weeks status post prior therapy to the brain and be off all steroids without progressing CNS disease.
- Hypercalcemia \>2.9 mmol/L, unresponsive to standard therapy (e.g., I.V. hydration, diuretics, calcitonin and/or bisphosphate therapy).
- Pregnant or nursing women due to the unknown effects of immunization on the developing fetus or newborn infant.
- Other malignancy within three years, unless the probability of recurrence is \<5%. Patients curatively treated for squamous cell carcinoma and basal cell carcinoma of the skin and carcinoma in situ of the uterine cervix (CIN) or patients with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study.
- History of organ transplant, or current active immunosuppressive therapy (such as cyclosporine, tacrolimus, etc.).
- Subjects taking systemic corticosteroid therapy for any reason including replacement therapy for hypoadrenalism, are not eligible. Subjects receiving inhaled or topical corticosteroids are eligible. Decadron treatment with docetaxel is acceptable.
- Significant or uncontrolled congestive heart failure (CHF), myocardial infarction, significant ventricular arrhythmias within the last six months or significant pulmonary dysfunction.
- Active infection or antibiotics within 48 hours prior to study enrollment, including unexplained fever (temp \> 38.1°C) if deemed clinically significant by the treating physician.
- Autoimmune disease (e.g., systemic lupus erythematosis (SLE), rheumatoid arthritis (RA), etc.). Patients with a remote history of asthma or mild active asthma are eligible.
- Other serious medical conditions that may be expected to limit life expectancy to less than 2 years (e.g., liver cirrhosis).
- Any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc).
- A known allergy to any component of the HyperAcute®-Lung immunotherapy or cell lines from which it is derived.
- Patients having undergone splenectomy.
- Known HIV positive.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
St. Joseph Heritage Healthcare
Santa Rosa, California, 95403, United States
Stamford Hospital
Stamford, Connecticut, 06902, United States
University of Florida
Gainesville, Florida, 32610, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Deaconess Clinic
Evansville, Indiana, 47713, United States
Indiana University Health Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Kansas Cancer Center
Fairway, Kansas, 66205, United States
North Mississippi Hematology and Oncology Associates at BridgePoint
Tupelo, Mississippi, 38801, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Richmond University Medical Center
Staten Island, New York, 10310, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27103, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Lynchburg Hematology Oncology Clinic
Lynchburg, Virginia, 24501, United States
Vince Lombardi Cancer Clinic
Green Bay, Wisconsin, 54311, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2013
First Posted
January 24, 2013
Study Start
February 1, 2013
Primary Completion
May 18, 2016
Study Completion
June 18, 2016
Last Updated
May 28, 2020
Record last verified: 2020-05