Actively Recruiting
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
Led by National Cancer Institute (NCI) · Updated on 2026-05-12
42
Participants Needed
34
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. It blocks the ability of a cell to repair damage to its deoxyribonucleic acid (DNA) and may kill tumor cells. It may also help some anticancer drugs work better. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make DNA and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy sources to kill tumor cells and shrink tumors. Giving TRC102 in combination with usual care treatment may be more effective than usual care treatment alone in stabilizing and lengthening survival time in patients with stage III non-squamous NSCLC.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed adenocarcinoma or large cell carcinoma of the lung
- Newly staged IIIA, IIIB, or IIIC lung cancer suitable for aggressive chemoradiotherapy
- Measurable disease with at least one lesion 3 20 mm by chest x-ray or 3 10 mm by CT, MRI, or clinical exam
- Diagnosed NSCLC without prior overlapping radiation for locally advanced disease
- Age 18 years or older
- Body weight over 30 kg with acceptable nutritional status
- ECOG performance status of 0 or 1 (Karnofsky 3 70%)
- Leukocytes 3 3,000/mcL
- Hemoglobin 3 9.0 g/dL
- Absolute neutrophil count 3 1,500/mcL
- Platelets 3 150,000/mcL
- Serum bilirubin within normal limits (exceptions for Gilbert's syndrome)
- AST and ALT 3 2.5 times upper limit of normal
- Creatinine 3 1.3 mg/dL
- Creatinine clearance 3 60 mL/min or GFR 3 50 mL/min/1.73 m2
- Acceptable lung function as assessed by physician
- Post-menopausal status or negative pregnancy test for pre-menopausal females
- Life expectancy of at least 12 months
- Stable HIV infection with controlled viral loads and adequate CD4 counts
- Undetectable HBV viral load if infected and cured or treated HCV infection
- Cardiac function class 2B or better
- Agree to use contraception during and 6 months after study participation if of child-bearing potential
- Ability to understand and sign informed consent
- Prior stage I/II NSCLC treated with surgery or stereotactic radiation without overlap is allowed
- Prior chemotherapy allowed at physician's discretion
You will not qualify if you...
- Not recovered from prior cancer therapy side effects above grade 1 except hair loss
- Receiving other investigational agents
- Treated or active brain metastases or leptomeningeal disease
- EGFR or ALK mutations
- Allergic reactions to TRC102 or similar compounds
- Uncontrolled illnesses including infection, heart failure, hypertension, unstable angina, arrhythmia, interstitial lung disease, serious gastrointestinal conditions, or psychiatric/social issues affecting compliance
- Pregnant or breastfeeding women
- Active or prior autoimmune or inflammatory disorders except certain controlled conditions
- Active infections including tuberculosis, hepatitis B (if not controlled), or hepatitis C (if not cured or treated)
- History of allogenic organ transplantation
- Other primary cancers except adequately treated cancers with low recurrence risk or non-melanoma skin cancers
- Psychiatric illness or social situations limiting compliance or consent capability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 34 locations
1
Keck Medicine of USC Buena Park
Buena Park, California, United States, 90621
Actively Recruiting
2
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
3
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Actively Recruiting
4
City of Hope Antelope Valley
Lancaster, California, United States, 93534
Actively Recruiting
5
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
6
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
7
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States, 92663
Actively Recruiting
8
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
9
City of Hope South Pasadena
South Pasadena, California, United States, 91030
Actively Recruiting
10
City of Hope Upland
Upland, California, United States, 91786
Actively Recruiting
11
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Actively Recruiting
12
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
13
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
14
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
15
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States, 33176
Actively Recruiting
16
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
17
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
18
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
Actively Recruiting
19
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
20
UChicago Medicine Northwest Indiana
Crown Point, Indiana, United States, 46307
Actively Recruiting
21
Jersey City Medical Center
Jersey City, New Jersey, United States, 07302
Actively Recruiting
22
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Actively Recruiting
23
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
Actively Recruiting
24
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
25
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
26
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States, 08876
Actively Recruiting
27
Community Medical Center
Toms River, New Jersey, United States, 08755
Actively Recruiting
28
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States, 10461
Active, Not Recruiting
29
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Active, Not Recruiting
30
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
31
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Actively Recruiting
32
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Actively Recruiting
33
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
34
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0565
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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