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Platinum-containing Compound

TRC102 + Chemotherapy/Radiation for Lung Cancer

Phase 2

Recruiting

Led By Tithi Biswas

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body weight > 30 kg with acceptable nutritional status based on evaluation by treating physician

Patients must have newly diagnosed non small cell lung cancer (NSCLC), with no prior overlapping radiation therapy or systemic antineoplastic therapy delivered for locally advanced NSCLC. Prior surgery is allowed

Must not have

Patients with treated brain metastases

Patients who have had prior chemotherapy or overlapping radiotherapy for lung cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization until death from any cause, assessed up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding TRC102 to the usual care treatment of pemetrexed, cisplatin, and radiation therapy followed by durvalumab works better than the usual care treatment alone in patients with stage III non-squamous non-small cell lung cancer.

Who is the study for?

Adults (18+) with stage III non-squamous NSCLC who haven't had chemotherapy or radiotherapy for lung cancer. They must have good heart, liver, and kidney function, controlled hepatitis if present, no severe autoimmune disorders or uncontrolled illnesses, and not be pregnant. Participants need measurable disease and acceptable blood counts.

What is being tested?

The trial is testing TRC102 combined with standard chemo (pemetrexed and cisplatin) plus radiation therapy followed by durvalumab against the usual treatment alone. The goal is to see if adding TRC102 improves tumor shrinkage and survival in patients.

What are the potential side effects?

Possible side effects include damage to DNA in cells which may lead to cell death, immune system reactions that could attack normal organs along with the cancer, fatigue from anemia due to chemotherapy drugs like pemetrexed and cisplatin, as well as potential kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh more than 30 kg and my doctor says my nutrition is good.

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I have newly diagnosed NSCLC and haven't had radiation or systemic therapy for it. Surgery is okay.

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I am 18 years old or older.

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I have chronic hepatitis B but my viral load is undetectable with treatment.

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My lung function is good, with FEV1 over 1.2 liters.

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I am post-menopausal or not pregnant if pre-menopausal.

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I have at least one tumor that can be measured.

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I had hepatitis C but have been treated and cured.

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I am mostly active and can care for myself.

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My kidney function, measured by creatinine clearance or GFR, is within the normal range.

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My cancer is at stage IIIA, IIIB, or IIIC and I can undergo intense treatment.

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My lung cancer is confirmed to be adenocarcinoma or large cell carcinoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatment for cancer that spread to my brain.

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I have had chemotherapy or radiotherapy for lung cancer before.

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I do not have any unmanaged ongoing illnesses.

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I do not have an active infection like TB, hepatitis B, or C.

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I have received an organ transplant from another person.

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I have new or worsening brain metastases or leptomeningeal disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization until death from any cause, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization until death from any cause, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until death from any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival (PFS)

Secondary study objectives

Incidence of grade 3 or higher adverse events

Overall survival (OS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (methoxyamine, usual care)Experimental Treatment9 Interventions

Patients receive methoxyamine PO on day 1 of each cycle, pemetrexed IV over 10 minutes on day 1 of each cycle, and cisplatin IV over 60 minutes or carboplatin IV over 30 minutes on day 3 of each cycle. Beginning day 3, patients also undergo radiation therapy daily Monday-Friday. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after cycle 2, patients receive durvalumab IV over 60 minutes every 2 weeks or monthly for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI throughout the trial and FDG-PET/CT scan during screening and optionally on study.

Group II: Arm II (usual care)Active Control8 Interventions

Patients receive pemetrexed IV over 10 minutes and cisplatin IV over 60 minutes or carboplatin IV over 30 minutes on day 1 of each cycle. Beginning day 1 of each cycle, patients also undergo radiation therapy daily Monday-Friday. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after cycle 2, patients receive durvalumab IV over 60 minutes every 2 weeks or monthly for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI throughout the trial and FDG-PET/CT scan during screening and optionally on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Methoxyamine

2007

Completed Phase 1

~90