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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression free survival (PFS)

Secondary outcome measures

Incidence of grade 3 or higher adverse events

Overall survival (OS)

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 PET/CT scan during screening and 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 PET/CT scan during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2008

Completed Phase 2

~2240

Radiation Therapy

2017

Completed Phase 3

~7250

Carboplatin

2014

Completed Phase 3

~6670

Cisplatin

2013

Completed Phase 3

~1940

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Pemetrexed

2014

Completed Phase 3

~5250

Computed Tomography

2017

Completed Phase 2

~2720

Durvalumab

2017

Completed Phase 2

~3870

Methoxyamine

2007

Completed Phase 1

~90

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,665 Previous Clinical Trials

40,925,812 Total Patients Enrolled

Tithi BiswasPrincipal InvestigatorCase Western Reserve University

1 Previous Clinical Trials

17 Total Patients Enrolled

Media Library

Cisplatin (Platinum-containing Compound) Clinical Trial Eligibility Overview. Trial Name: NCT05198830 — Phase 2

Lung Cancer Research Study Groups: Arm I (methoxyamine, usual care), Arm II (usual care)

Lung Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT05198830 — Phase 2

Cisplatin (Platinum-containing Compound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05198830 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the sample size of this empirical study?

"Yes, current records on clinicaltrials.gov suggest that this research is in the process of enrolling participants. The trial was initially uploaded onto 5/20/2022 and recently updated 10/28/2022. 78 volunteers are needed from 2 different medical centres."

Answered by AI

Is this experiment open to new participants at the present moment?

"The clinical trial registry on clinicialtrials.gov reveals that this research project posted at the beginning of May and has been recently updated in late October is actively recruiting participants."

Answered by AI