Testing the Addition of TRC102 to Usual Chemotherapy During Radiation for Stage III Non-Squamous Non-Small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT05198830
This study is exploring whether adding a new drug, TRC102, to the usual chemotherapy and radiation treatment can better shrink tumors in patients with stage III non-squamous non-small cell lung cancer. The trial will compare the effectiveness of this combination against the standard treatment alone.
Patient Parameters
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Program Overview
This phase II trial is testing if adding TRC102 to the usual treatment of chemotherapy (pemetrexed, cisplatin, or carboplatin) and radiation therapy, followed by the immunotherapy drug durvalumab, can more effectively shrink tumors in patients with stage III non-squamous non-small cell lung cancer (NSCLC). TRC102 is a drug that may help stop cancer cells from repairing themselves, potentially making other cancer treatments work better. The study aims to see if this combination can improve survival and control the cancer better than the usual treatment alone.
Description
The main goal of this study is to see if the new combination treatment can help patients live longer without their cancer getting worse, compared to the standard treatment. Researchers also want to see how long patients live overall and check for any serious side effects.
Participants will be randomly assigned to one of two groups:
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Group 1: Patients will take TRC102 by mouth, along with chemotherapy drugs pemetrexed and either cisplatin or carboplatin, and receive radiation therapy. This treatment cycle repeats every 21 days for two cycles. Afterward, they will receive durvalumab every two weeks or monthly for up to a year, as long as the cancer does not progress or cause unacceptable side effects. Patients will also have regular scans to monitor their cancer.
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Group 2: Patients will receive the usual chemotherapy drugs pemetrexed and either cisplatin or carboplatin, along with radiation therapy. This treatment cycle also repeats every 21 days for two cycles. Afterward, they will receive durvalumab every two weeks or monthly for up to a year, as long as the cancer does not progress or cause unacceptable side effects. Patients will also have regular scans to monitor their cancer.
After completing the study treatment, patients will have follow-up visits at 30 days, then every three months for two years, and every six months for an additional three years.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with stage IIIA, IIIB, or IIIC non-squamous non-small cell lung cancer (NSCLC).
- Have at least one tumor that can be measured by scans.
- Newly diagnosed with NSCLC, with no prior overlapping radiation therapy for advanced NSCLC.
- Aged 18 years or older.
- Weigh more than 30 kg and have good nutritional status.
- Good overall health with an ECOG performance status of 0 or 1.
- Meet specific blood count and organ function requirements.
- Women must not be pregnant and must agree to use effective contraception during and after the study.
- HIV-positive patients may participate if their condition is stable and they meet specific health criteria.
- Patients with controlled hepatitis B or cured hepatitis C are eligible.
- Patients with a history of heart disease must have a good heart function assessment.
- Agree to use contraception during and after the study.
- Able to understand and sign a consent form.
- Patients with certain genetic mutations or prior early-stage lung cancer treatment may be eligible.
Exclusion Criteria
- Have not recovered from side effects of previous cancer treatments.
- Currently taking other experimental drugs.
- Have active or untreated brain metastases.
- Have a history of severe allergic reactions to similar drugs.
- Have uncontrolled health conditions that could interfere with the study.
- Pregnant or breastfeeding women.
- Have active autoimmune or inflammatory disorders, with some exceptions.
- Have active infections like tuberculosis or hepatitis.
- Have had an organ transplant.
- Have another active cancer, with some exceptions for certain treated cancers.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Keck Medicine of USC Buena Park | 90621 | Buena Park | California |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| City of Hope at Irvine Lennar | 92618 | Irvine | California |
| Los Angeles General Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| USC Norris Oncology/Hematology-Newport Beach | 92663 | Newport Beach | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | 33146 | Coral Gables | Florida |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | 33442 | Deerfield Beach | Florida |
| University of Florida Health Science Center - Gainesville | 32610 | Gainesville | Florida |
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