202301032 : ADI-PEG 20 in combination with gemcitabine and docetaxel after progression on frontline therapy in non-small cell and small cell lung cancers

Phase I: To determine the safety, tolerability and recommended phase II dose (RP2D) of the combination of ADI-PEG 20, gemcitabine, and docetaxel when given to patients with small cell and non-small cell lung cancers that have progressed on frontline therapy
Phase II: To determine objective response rate (ORR) in two cohorts: (1) patients with small cell lung cancers that have progressed on frontline therapy who are treated with ADI-PEG 20 in combination with gemcitabine and docetaxel and (2) patients with non-small cell lung cancers that have progressed on frontline therapy who are treated with ADI-PEG 20 in combination with gemcitabine and docetaxel.

For information, visit: NCT05616624

Inova Schar Cancer Institute
A division of Inova Fairfax Hospital
8081 Innovation Park Drive 
Fairfax, VA 22031

1. 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.
2. Treated with at least one previous line of systemic therapy. 
a. Patients with ES-SCLC must have been treated with first-line therapy of platinum doublet + anti-PD(L)1 therapy, if eligible.
b. 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.
c. 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. 
3. At least 18 years of age.
4. Ability to understand and willingness to sign an IRB approved written informed consent document.

1. A history of other malignancy with the exception of:
a. Malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease 
b. Basal cell or squamous cell carcinoma of the skin which was treated with local resection only
c. Carcinoma in situ of the cervix 
d. Other tumors discussed with the study PI 2. Currently receiving any other investigational agents. 3. Prior treatment with ADI-PEG 20 or gemcitabine (prior docetaxel is allowed). 4. 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. 5. 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. 6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. 7. History of seizure disorder not related to underlying cancer. 8. Clinically significant Grade 2 or higher neuropathy. 9. Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. 10. Patients with known active Hepatitis B or C or HIV.