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Alkylating agents

Radiation + Chemotherapy for Advanced Lung Cancer

Charlotte, NC
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
Age ≥18 years.
ECOG performance status ≤ 2
Must not have
Centrally located primary tumor < 2 cm from involved nodal disease which would result in significant overlap of radiation dose. Centrally located is defined as within or touching the zone of the proximal bronchial tree, which is a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi).
Subjects who have had prior radiation to the region of the chest that would result in overlap of radiation therapy fields and determined by the treating physician to impede the treatment of the study malignancy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to best response while on study treatment; participants remained on study treatment (including sbrt, chemoradiation, and durvalumab) 4.5 months on average.
Awards & highlights
No Placebo-Only Group

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.

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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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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 lung cancer diagnosis was confirmed through lab tests.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My lung tumor is close to the center and near important airways.
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I've had chest radiation before that might affect new treatment.
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I have received treatment that affects my whole body for lung cancer.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to best response while on study treatment; participants remained on study treatment (including sbrt, chemoradiation, and durvalumab) 4.5 months on average.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to best response while on study treatment; participants remained on study treatment (including sbrt, chemoradiation, and durvalumab) 4.5 months on average. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Progression Free and Surviving at 12 Months
Secondary study objectives
Distant Control at 12 and 24 Months
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Quality of Life Score
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Lung Cancer (EORTC QLQ-LC13) Symptom Scores
+8 more
Other study objectives
Number of Participants Who Discontinued Study Treatment Due to Adverse Events
Number of Participants Who Received Durvalumab
Number of Participants With Grade 2 or Higher Radiation Pneumonitis
+4 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
Thrombocytopenia
2%
colitis
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Carboplatin
2014
Completed Phase 3
~6450
Paclitaxel
2011
Completed Phase 4
~5450
Etoposide
2010
Completed Phase 3
~2970
SBRT
2014
Completed Phase 2
~1100
IMRT
2003
Completed Phase 3
~1540
Durvalumab
2017
Completed Phase 4
~3890

Find a Location

Closest Location:Levine Cancer Institute· Charlotte, NC

Who is running the clinical trial?

Atrium HealthLead Sponsor
121 Previous Clinical Trials
34,861 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,429 Previous Clinical Trials
2,503,167 Total Patients Enrolled
Atrium Health Levine Cancer InstituteOTHER
29 Previous Clinical Trials
4,658 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,485 Previous Clinical Trials
290,538,259 Total Patients Enrolled
John H HeinzerlingPrincipal InvestigatorWake Forest University Health Sciences

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
~7 spots leftby Mar 2026
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