Combining ADI-PEG 20 with Gemcitabine and Docetaxel for Lung Cancer After Initial Treatment Failure
ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers
This study is testing if a new combination of treatments can help people with lung cancer who didn't respond to their first round of therapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Trial ID | NCT05616624 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of ADI-PEG 20 in combination with gemcitabine and docetaxel for patients with small cell or non-small cell lung cancer who have experienced progression after frontline therapy. The study is divided into two phases, with the first phase focusing on determining the recommended dose of the treatment regimen. Once the optimal dose is established, the second phase will evaluate the efficacy of this combination therapy in treating the targeted lung cancers. The trial aims to improve treatment options for patients who have limited choices after their initial therapies fail.
Who should consider this trial
Good fit: Ideal candidates include patients with extensive stage small cell lung cancer or metastatic non-small cell lung cancer who have progressed on prior treatments and are deemed fit for chemotherapy.
Not a fit: Patients who have not received prior systemic therapy or those with driver mutations in NSCLC may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced lung cancer who have not responded to standard therapies.
How similar studies have performed: While the combination of these therapies has been explored in other contexts, this specific approach in lung cancer is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois and 2 other locations
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
- Inova Schar Cancer Institute — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Brian A Van Tine, M.D., Ph.D. — Washington University School of Medicine
- Study coordinator: Brian A Van Tine, M.D., Ph.D.
- Email: bvantine@wustl.edu
- Phone: 314-362-8903
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.