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Alkylating agents

Radiation + Chemotherapy for Advanced Lung Cancer

Phase 2

Waitlist Available

Led By John H Heinzerling

Research Sponsored by Atrium Health

Eligibility Criteria Checklist

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

Must have

FEV1 ≥ 1.0 Liter or ≥ 40% predicted with or without bronchodilator within six months prior to initiation of study treatment. Subjects who meet the criterion without O2, but who need acute (started within 10 days prior to enrollment) supplemental oxygen due to tumor-caused obstruction/hypoxia are eligible, provided the amount of the O2 needed has been stable.

Age ≥18 years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial will test if a new cancer treatment is effective in treating locally-advanced NSCLC. The treatment involves radiation and chemotherapy, with or without additional consolidation chemotherapy. A total of 60 people will be enrolled over 4 years.

Who is the study for?

This trial is for adults over 18 with stage II or III non-small cell lung cancer (NSCLC) who haven't had systemic therapy for lung cancer or radiation that overlaps with the study area. They must have a certain level of lung function and agree to use contraception if they can have children. People with tumors too close to central airways, on other trials, or with recent invasive cancers are excluded.Check my eligibility

What is being tested?

The study tests high-dose radiation (SBRT) followed by chemotherapy and more radiation (IMRT) in people with advanced NSCLC. Some may also get consolidation chemo. Durvalumab might be added depending on what the doctor thinks is best. The goal is to see how patients do after one year.See study design

What are the potential side effects?

Possible side effects include skin reactions from radiation, fatigue, nausea from chemotherapy drugs like Carboplatin and Paclitaxel, kidney issues from Cisplatin, low blood counts leading to infection risk, and immune-related effects if given Durvalumab.

Eligibility Criteria

Inclusion Criteria

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

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My lung function is within the required range, and if I'm using oxygen, it's stable.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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My blood counts and kidney and liver functions are within normal ranges.

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My CT scan shows a non-cancerous fluid buildup in my chest that's too small for a fluid removal procedure.

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My doctor thinks I am a good candidate for durvalumab treatment.

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My cancer is at stage II or III, and my primary tumor is 7 cm or smaller.

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My lung cancer diagnosis was confirmed through lab tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

12-Month Progression Free Survival

Secondary outcome measures

Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Score

Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 13 (EORTC QLQ-LC13) Score

Change from Baseline in MD Anderson Symptom Inventory - Lung Cancer (MDASI-LC) Score

+8 more

Other outcome measures

Incidence of Grade 2 or higher adverse events of special interest

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment7 Interventions

SBRT + Concurrent Mediastinal Chemoradiation +/- Consolidation Chemotherapy/Adjuvant Immunotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SBRT

2014

Completed Phase 2

~1060

Carboplatin

2014

Completed Phase 3

~6670

Paclitaxel

2011

Completed Phase 4

~5380

Etoposide

2010

Completed Phase 3

~2440

IMRT

2003

Completed Phase 3

~1570

Durvalumab

2017

Completed Phase 2

~3870

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Atrium HealthLead Sponsor

121 Previous Clinical Trials

34,793 Total Patients Enrolled

Wake Forest University Health SciencesLead Sponsor

1,240 Previous Clinical Trials

1,004,146 Total Patients Enrolled

Atrium Health Levine Cancer InstituteOTHER

17 Previous Clinical Trials

1,459 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03141359 — Phase 2

Lung Cancer Research Study Groups: Single Arm

Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03141359 — Phase 2

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03141359 — Phase 2

Frequently Asked Questions

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

Is this research endeavor currently taking on new participants?

"The clinicaltrials.gov entry for this study reveals that it is no longer recruiting participants; the listing was first made available on May 11th 2017 and last edited November 16th 2022. Despite this, there are presently 1,688 other trials actively enrolling patients."

Answered by AI

To what extent is stereotactic body radiation therapy hazardous for individuals?

"Due to the lack of efficacy data, SBRT's safety was rated as a 2 on our scale. This is justified by the fact that it is only in Phase 2 clinical trials at this moment."

Answered by AI

How many individuals are participating in this medical experiment?

"This clinical trial is no longer actively enrolling patients. Initially posted on May 11th, 2017 and most recently updated on November 16th 2022, this study has reached its recruitment limit. However, 3 ongoing trials pertaining to lung health are still recruiting as well as 1,685 SBRT studies that need participants."

Answered by AI

What other tests have been performed to evaluate the effectiveness of SBRT?

"Currently, there are 1685 trials involving stereotactic body radiation therapy (SBRT), with 431 of them in the late stages. Shanghai is one of the many cities running these studies and globally, SBRT clinical trials are taking place at 89647 sites."

Answered by AI