What is TRC102 studying for stage III non-squamous non-small cell lung cancer?

TRC102 is being studied to see if adding it to the usual chemotherapy, radiation, and durvalumab treatment can better shrink tumors and improve progression-free survival. Researchers want to find out if this combination provides more benefit than the standard treatment alone. The study is sponsored by the National Cancer Institute (NCI).

Who may be eligible for this stage III non-squamous non-small cell lung cancer clinical trial?

Adults aged 18 years or older with confirmed stage III non-squamous NSCLC may be eligible. Participants must have good organ function, no active brain metastases, and not be pregnant. People with certain infections or autoimmune conditions may qualify with specific restrictions. Please review eligibility criteria for more details.

Is there any cost to participate in this stage III non-squamous non-small cell lung cancer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses vary by participant and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID05198830

Phase II Study of TRC102 Added to Standard Chemotherapy and Radiation Followed by Durvalumab for Stage III Non-Squamous Non-Small Cell Lung Cancer

Led by National Cancer Institute (NCI) · Updated on 2026-08-06

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether adding the drug TRC102 to the usual chemotherapy and radiation treatment followed by durvalumab can better shrink tumors in patients with stage III non-squamous non-small cell lung cancer NSCLC. This phase II trial explores whether the combination therapy improves progression-free survival compared to the standard treatment alone. TRC102 blocks cancer cells ability to repair DNA damage, potentially helping other anticancer drugs work more effectively. Participants are randomly assigned to one of two treatment groups. One group receives TRC102 orally along with pemetrexed and either cisplatin or carboplatin intravenously, plus daily radiation therapy Monday through Friday for two 21-day cycles, followed by durvalumab infusions every 2 weeks or monthly for up to one year. The other group receives the usual chemotherapy and radiation followed by durvalumab on the same schedule. Imaging scans such as CT, MRI, and FDG-PETCT are done at screening and throughout the trial to monitor the cancer. During the study, participants will be closely monitored with regular imaging scans and clinical assessments. After completing treatment, follow-up visits occur at 30 days, then every 3 months for 2 years, and every 6 months for an additional 3 years to track progression-free survival, overall survival, and any side effects. The total participation time can extend up to 5 years to fully evaluate the outcomes and safety of the treatments.

CONDITIONS

Brief 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

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients must have confirmed adenocarcinoma or large cell carcinoma of the lung by histology or cytology
Newly staged IIIA, IIIB, or IIIC disease suitable for aggressive chemoradiotherapy
Measurable disease with at least one lesion ≥ 2 cm by chest x-ray or ≥ 1 cm 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 nutrition
ECOG performance status 0 or 1 (Karnofsky ≥ 70%)
Leukocytes ≥ 3,000/mcL, Hemoglobin ≥ 9.0 g/dL, Neutrophils ≥ 1,500/mcL, Platelets ≥ 150,000/mcL
Normal bilirubin, AST ≤ 2.5x upper normal limit, ALT ≤ 2.5x upper normal limit
Creatinine ≤ 1.3 mg/dL; creatinine clearance ≥ 60 mL/min or GFR ≥ 50 mL/min/1.73 m²
Acceptable lung function as assessed by physician
Women must be post-menopausal or have negative pregnancy tests; men and women must use contraception
Life expectancy at least 12 months
HIV positive patients may participate if stable with undetectable viral load and adequate CD4 counts
Controlled hepatitis B or cured hepatitis C infection
Cardiac function class 2B or better by NYHA classification
Ability to understand and sign informed consent
Prior stage I/II NSCLC treated with surgery or stereotactic body radiotherapy allowed

You will not qualify if you...

Unresolved toxicities greater than grade 1 from prior anti-cancer therapy except hair loss
Receiving other investigational agents
Treated or active brain metastases or leptomeningeal disease
EGFR or ALK mutations
Allergic reactions to study drugs or similar compounds
Uncontrolled illnesses like active infection, heart failure, unstable angina, arrhythmia, interstitial lung disease, serious gastrointestinal conditions, or psychiatric/social issues limiting compliance
Pregnant or breastfeeding women
Active or recent autoimmune or inflammatory disorders except specific controlled exceptions
Active infections such as tuberculosis or hepatitis B (with active viral load)
History of allogenic organ transplant
Other primary malignancies except certain treated cancers with no active disease
Psychiatric illness or social situations limiting study compliance

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Phase II Study of TRC102 Added to Standard Chemotherapy and Radiation Followed by Durvalumab for Stage III Non-Squamous Non-Small Cell Lung Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria