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New treatment option for Lung Adenocarcinoma
Official title Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05198830
What this study is testing
What is Carboplatin?
Carboplatin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for lung adenocarcinoma.
Also referred to as Blastocarb, Carboplat.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial tests whether TRC102 (methoxyamine hydrochloride) in combination usual care treatment comprised of pemetrexed, cisplatin or carboplatin, and radiation therapy followed by durvalumab works better than the usual care treatment alone to shrink tumors in patients with stage III non-squamous non-small cell lung cancer (NSCLC). TRC102 is in a class of drugs called antineoplastic agents.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have histologically or cytologically confirmed adenocarcinoma or large cell carcinoma of the lung with confirmation by...
- Patients must have newly staged IIIA, IIIB or IIIC disease according to the 8th tumor, node, metastasis (TNM) staging classification and to be...
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to...
- Patients must have diagnosed NSCLC, with no prior overlapping radiation therapy delivered for locally advanced NSCLC. Prior stereotactic radiation...
- Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of TRC102 in combination with pemetrexed, cisplatin, and...
You likely can't join if
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception...
- Patients who are receiving any other investigational agents.
- Patients with treated brain metastases are not eligible as the study is for stage III disease only.
- Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are not eligible as the study includes only...
- Patients with EGFR or ALK mutations are ineligible.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to TRC102 or other agents used in study.
See the full eligibility criteria
Who can join
- Patients must have histologically or cytologically confirmed adenocarcinoma or large cell carcinoma of the lung with confirmation by immunohistochemistry (histologic tissue diagnosis is preferred, but cytology is...
- Patients must have newly staged IIIA, IIIB or IIIC disease according to the 8th tumor, node, metastasis (TNM) staging classification and to be considered appropriate candidates for aggressive chemoradiotherapy.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as...
- Patients must have diagnosed NSCLC, with no prior overlapping radiation therapy delivered for locally advanced NSCLC. Prior stereotactic radiation therapy for stage I lung cancer without overlapping is allowed. Prior...
- Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of TRC102 in combination with pemetrexed, cisplatin, and durvalumab in patients \< 18 years of age, children are excluded from...
- Body weight \> 30 kg with acceptable nutritional status based on evaluation by treating physician.
- Eastern Cooperative Oncology Group (ECOG) performance status =\ = 70%).
- Leukocytes \>= 3,000/mcL.
- Hemoglobin \>= 9.0 g/dL.
- Absolute neutrophil count \>= 1,500/mcL.
- Platelets \>= 150,000/mcL.
- Serum bilirubin within normal institutional limits (0 - 1.2 mg/ dl). (This will not apply to patients with confirmed Gilbert's syndrome [persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in...
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) =\< 2.5 x institutional upper limit of normal (=\< 39 U/L).
- Alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =\< 2.5 x institutional upper limit of normal (=\< 52 U/L).
- Creatinine =\< 1.3 mg/dL.
- Measured creatinine clearance \>= 60 mL/min OR glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2.
- Acceptable pulmonary function as assessed by treating physician.
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an...
- Women \< 60 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and...
- Women \>= 60 years of age will be considered post-menopausal.
- Life expectancy \>= 12 months.
- Patients who are human immunodeficiency virus (HIV) positive may participate IF they meet the following eligibility requirements:
- They must be stable on their anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on the same regimen; the most recent undetectable viral load must be within the past...
- They must have a CD4 count of greater than 250 cells/mcL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count \< 200 cells/mcL over the past 2 years, unless it was deemed related...
- For patients who have received chemotherapy in the past 6 months, a CD4 count \< 250 cells/mcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy.
- They must have an undetectable viral load and a CD4 count \>= 250 cells/mcL within 7 days of enrollment.
- They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months.
- HIV-infected patients should be monitored every 12 weeks for viral load and CD4 counts.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral...
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- The effects of TRC102 on the developing human fetus are unknown. For this reason and because biochemical inhibitors of the BER pathway agents as well as other therapeutic agents used in this trial are known to be...
- Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and/or family member...
- Patients with prior stage I/II non-small cell lung cancer treated with surgery are eligible. Patients with prior stage I NSCLC treated with stereotactic body radiotherapy (SBRT) without overlapping radiation fields...
What rules you out
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia.
- Patients who are receiving any other investigational agents.
- Patients with treated brain metastases are not eligible as the study is for stage III disease only.
- Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are not eligible as the study includes only stage III disease.
- Patients with EGFR or ALK mutations are ineligible.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to TRC102 or other agents used in study.
- Patients with uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia...
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because TRC102 is a biochemical inhibitor of the BER pathway and durvalumab is an anti-PDL1 antibody, agents with the potential for teratogenic or abortifacient effects...
- Women of child-bearing potential and men 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 6 months...
- Patients with active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic...
- Patients with vitiligo or alopecia.
- Patients with hypothyroidism (e.g. following Hashimoto thyroiditis) stable on hormone replacement.
- Any chronic skin condition that does not require systemic therapy.
- Patients without active disease in the last 5 years may be included but only after consultation with the study physician.
- Patients with celiac disease controlled by diet alone.
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), hepatitis B (known...
- History of allogenic organ transplantation.
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no active disease before the first dose of investigational product (IP) and of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated any carcinoma in situ without evidence of disease.
- Prostate cancer with stable disease with active or prior treatment that will not interfere with current lung cancer treatment will be eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Buena Park, California, United States
- Duarte, California, United States
- Irvine, California, United States
- Lancaster, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Sacramento, California, United States
- South Pasadena, California, United States
- Upland, California, United States
- Coral Gables, Florida, United States
- Deerfield Beach, Florida, United States
- Gainesville, Florida, United States
- Miami, Florida, United States
- Plantation, Florida, United States
- Chicago, Illinois, United States
- New Lenox, Illinois, United States
- Orland Park, Illinois, United States
- Crown Point, Indiana, United States
- Jersey City, New Jersey, United States
- Livingston, New Jersey, United States
+ 10 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buena Park, California, United States; Duarte, California, United States; Irvine, California, United States; Lancaster, California, United States; Los Angeles, California, United States; Newport Beach, California, United States and 24 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.