Trial Title:
ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers
NCT ID:
NCT05616624
Condition:
Non Small Cell Lung Cancer
Non-small Cell Lung Cancer
Small-cell Lung Cancer
Small Cell Lung Carcinoma
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Gemcitabine
Docetaxel
Conditions: Keywords:
Arginine Starvation
ADI-PEG20
SCLC
NSCLCa
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ADI-PEG 20
Description:
-Given 60 minutes (+/- 15 minutes) prior to docetaxel
Arm group label:
Phase I: ADI-PEG + gemcitabine + docetaxel
Arm group label:
Phase II Non-small cell lung cancer: ADI-PEG + gemcitabine + docetaxel
Arm group label:
Phase II Small cell lung cancer: ADI-PEG + gemcitabine + docetaxel
Other name:
PEGylated arginine deiminase
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
-Given over the course of 90 minutes (+/- 10 minutes)
Arm group label:
Phase I: ADI-PEG + gemcitabine + docetaxel
Arm group label:
Phase II Non-small cell lung cancer: ADI-PEG + gemcitabine + docetaxel
Arm group label:
Phase II Small cell lung cancer: ADI-PEG + gemcitabine + docetaxel
Other name:
Gemzar
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
-Given over the course of 60 minutes (+/- 10 minutes)
Arm group label:
Phase I: ADI-PEG + gemcitabine + docetaxel
Arm group label:
Phase II Non-small cell lung cancer: ADI-PEG + gemcitabine + docetaxel
Arm group label:
Phase II Small cell lung cancer: ADI-PEG + gemcitabine + docetaxel
Other name:
Taxotere
Summary:
In this study, patients with small cell or non-small cell lung cancer will receive
ADI-PEG 20, gemcitabine, and docetaxel after demonstrated progression on frontline
therapy. In phase I of the study, up to 6 dose levels will be tested to find the
recommended phase II dose (RP2D), after which patients enrolling to phase II will be
treated at that dose level to assess efficacy. Although safety and tolerability has been
previously determined in the sarcoma population, dose de-escalations of the
chemotherapies in that patient population were required. Therefore, a phase I portion
will be incorporated to determine the RP2D of the triplet in this population.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically or cytologically confirmed extensive stage small cell or metastatic
non-small cell lung cancer that has progressed on frontline therapy who are fit for
treatment with gemcitabine and docetaxel in the opinion of the treating physician.
Phase II enrollment will occur separately to the SCLC and NSCLC cohorts, with up to
36 enrolled in each cohort.
- Measurable disease per RECIST 1.1.
- Treated with at least one previous line of systemic therapy. The allowable window
between treatments is 21 days for chemotherapy or a TKI or 5 half-lives for a TKI
(whichever is shorter), 21 days and progression by CT for immunotherapy, 21 days for
RT, 21 days for surgery, or 28 days for an investigational agent.
- Patients with ES-SCLC must have been treated with first-line therapy of
platinum doublet + anti-PD(L)1 therapy, if eligible.
- Patients with NSCLC without a driver mutation must have been treated with
first-line therapy of platinum doublet + anti-PD(L)1 therapy, if eligible.
- Patients with NSCLC with a driver mutation (EGFR, ALK, ROS1) must have been
treated with an FDA approved targeted therapy and subsequent platinum doublet
therapy, if eligible.
- At least 18 years of age.
- ECOG performance status ≤ 1.
- Normal bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1.5 K/cumm
- Platelets ≥ 100 K/cumm
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 2 x IULN, patients with Gilberts must be below 3xIULN
- AST(SGOT)/ALT(SGPT) ≤ 3 x IULN (or ≤ 5 x IULN if liver metastases are present)
- Creatinine clearance > 60 mL/min by MDRD or by 24 hour urine
- Serum uric acid ≤ 8 mg/dL (with or without medication control)
- The effects of ADI-PEG 20 on the developing human fetus are unknown. For this reason
and because chemotherapeutics are known to be teratogenic, women of childbearing
potential must agree to use adequate contraception (hormonal or barrier method of
birth control, abstinence) prior to study entry, for the duration of study
participation, and for one month after completion of study treatment. Should a woman
become pregnant or suspect she is pregnant while participating in this study, she
must inform her treating physician immediately. Men treated or enrolled on this
protocol must also agree to use adequate contraception prior to the study, for the
duration of the study, and for one month after completion of study treatment.
- Ability to understand and willingness to sign an IRB approved written informed
consent document.
Exclusion Criteria:
- A history of other malignancy with the exception of:
- Malignancies for which all treatment was completed at least 2 years before
registration and the patient has no evidence of disease
- Basal cell or squamous cell carcinoma of the skin which was treated with local
resection only
- Carcinoma in situ of the cervix
- Other tumors discussed with the study PI
- Currently receiving any other investigational agents.
- Prior treatment with ADI-PEG 20 or gemcitabine (prior docetaxel is allowed).
- Presence of untreated or unstable brain metastases. Patients with treated/stable
brain metastases, defined as patients who have received prior therapy for their
brain metastases and whose CNS disease is radiographically stable at study entry,
are eligible.
- A history of allergic reactions attributed to compounds of similar chemical or
biologic composition to ADI-PEG 20, gemcitabine, pegylated compounds, or other
agents used in the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, or
cardiac arrhythmia.
- History of seizure disorder not related to underlying cancer.
- Grade 2 or higher neuropathy
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative
pregnancy test within 14 days of study entry.
- Patients with known active Hepatitis B or C or HIV.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian A Van Tine, M.D., Ph.D.
Phone:
314-362-8903
Email:
bvantine@wustl.edu
Investigator:
Last name:
Brian A Van Tine, M.D., Ph.D.
Email:
Principal Investigator
Investigator:
Last name:
Jared Cohen, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Ramaswamy Govindan, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Daniel Morgensztern, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Saiama Waqar, MBBS
Email:
Sub-Investigator
Investigator:
Last name:
Esther Lu, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Sasha Harberg, PharmD, BCOP
Email:
Sub-Investigator
Facility:
Name:
Inova Schar Cancer Institute
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nagla Abdel Karim, M.D.
Phone:
855-694-6682
Investigator:
Last name:
Nagla Abdel Karim, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Raymond Wadlow, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Teja Poosarla, M.D.
Email:
Sub-Investigator
Start date:
April 5, 2023
Completion date:
December 31, 2032
Lead sponsor:
Agency:
Washington University School of Medicine
Agency class:
Other
Collaborator:
Agency:
Polaris Group
Agency class:
Industry
Source:
Washington University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05616624
http://www.siteman.wustl.edu
