What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, radiation therapy, and targeted therapies. Daily Online Adaptive Radiotherapy, which adjusts the radiation plan based on daily imaging, aims to better target the tumor while sparing normal tissues. The side effects of such advanced radiation techniques can include acute esophagitis, pneumonitis, and fatigue. Compared to non-adaptive radiotherapy, these techniques may reduce the severity of these side effects by minimizing radiation exposure to healthy tissues.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Small Cell Lung Cancer (NSCLC) that combine radiotherapy with chemotherapy or immunotherapy. Notable approvals include the use of chemoradiotherapy regimens such as cisplatin plus etoposide, and carboplatin plus paclitaxel, often in conjunction with radiation therapy. Additionally, the FDA has approved the use of immunotherapy agents like durvalumab for patients with unresectable stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiotherapy. These treatments aim to enhance the effectiveness of radiotherapy while minimizing damage to normal tissues.

What other types of research exist?

Promising novel alternatives to Daily Online Adaptive Radiotherapy for NSCLC patients include: 1) Standard-dose (60 Gy) Intensity-Modulated Radiotherapy (IMRT) combined with chemotherapy, which has shown lower heart doses and reduced severe pneumonitis compared to higher-dose RT. 2) Hypofractionated radiotherapy, which delivers higher doses per fraction over fewer sessions, potentially improving convenience and reducing overall treatment time. 3) The combination of carboplatin and paclitaxel with or without cetuximab, although cetuximab did not significantly improve overall survival, it remains a consideration for specific patient profiles.

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Radiation Therapy

Adaptive Radiation Therapy for Stage III Lung Cancer (ARTIA-Lung Trial)

N/A

Waitlist Available

Led By Andrew McDonald, MD

Research Sponsored by Varian, a Siemens Healthineers Company

Eligibility Criteria Checklist

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

Must have

Measurable disease must be present

Clinical stage IIIC due to contralateral mediastinal lymph node involvement only (e.g., no contralateral hilar or any supraclavicular/cervical lymph node metastases). Mediastinal stations 2R and 4R are considered contralateral for patients whose primary tumor is within the left lung. Mediastinal stations 2L, 4L, 5, and 6 are considered contralateral for patients whose primary tumor is in the right lung

Must not have

Severe active chronic obstructive pulmonary disease or respiratory illness other than NSCLC precluding study therapy

Evidence of malignant pleural effusion, defined as either FDG PET avidity within effusion fluid or presence of malignant cells identified by cytology of thoracentesis fluid

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to 90 days after completion of chemoradiotherapy

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way of giving radiation therapy that adjusts regularly based on the patient's condition, combined with chemotherapy. It aims to help people with stage III non-small cell lung cancer. The goal is to reduce side effects like breathing and swallowing problems by targeting the cancer more precisely.

Who is the study for?

This trial is for adults over 18 with stage IIIA-IIIB non-small cell lung cancer (NSCLC) who are not candidates for surgery. Participants must have no distant metastases, normal organ and marrow function, and an ECOG performance status of 0-2. They should not have had previous thoracic radiation or other cancers within the last three years.

What is being tested?

The study compares daily online adaptive radiotherapy combined with chemotherapy against standard non-adaptive radiotherapy with chemotherapy in treating stage III NSCLC. The goal is to see if the adaptive method reduces acute respiratory and esophageal toxicity one month post-treatment.

What are the potential side effects?

Potential side effects include acute respiratory issues like coughing or difficulty breathing, as well as esophageal problems such as pain when swallowing. These will be measured using patient-reported outcomes.

Eligibility Criteria

Inclusion Criteria

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

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My cancer can be measured by tests.

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My cancer is stage IIIC with specific lymph node involvement.

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My organs and bone marrow are functioning normally.

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I had a PET-CT scan within the last 2 months.

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My cancer is at stage IIIA-IIIB.

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My treatment team has decided that surgery is not an option for me.

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My kidney function test shows creatinine is 1.5 mg/dL or less.

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My lung cancer has been confirmed through tissue examination.

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I can care for myself and am considered fit for chemoradiotherapy.

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I have chosen not to undergo surgery for my condition.

Exclusion Criteria

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

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I do not have severe COPD or other lung problems that would stop me from receiving the study treatment.

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My tests show cancer cells in the fluid around my lungs.

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I haven't been hospitalized for lung issues other than my cancer in the last year.

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I am a woman who can have children and I am not using birth control.

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I have severe difficulty breathing, coughing, or swallowing.

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My cancer has spread to lymph nodes above my collarbone or on the opposite side of my chest.

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I have had radiation therapy to my chest area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to 90 days after completion of chemoradiotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to 90 days after completion of chemoradiotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to 90 days after completion of chemoradiotherapy for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Acute toxicity

Secondary study objectives

Global quality of life

Healthcare resource utilization

Local progression

+5 more

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531

29%

Nausea

19%

Leukopenia

14%

Anaemia

14%

Vomiting

14%

Neutropenia

14%

White blood cell count decreased

14%

Thrombocytopenia

14%

Alanine aminotransferase increased

10%

Neutrophil count decreased

10%

Platelet count decreased

10%

Aspartate aminotransferase increased

Musculoskeletal pain

Dizziness

Diarrhea

Back pain

100%

80%

60%

40%

20%

Study treatment Arm

Erlotinib-Chemotherapy

Chemotherapy-Erlotinib

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: Adaptive ArmExperimental Treatment3 Interventions

Subjects in this arm will receive their external beam radiotherapy on the Ethos Radiotherapy System version 2.0 with HyperSight cone beam computed tomography imaging, with daily online adaptation of their radiation dosimetry plan to account for day-to-day changes in the tumor and surrounding anatomical structures. All subjects will received standard concurrent chemotherapy and may receive adjuvant immunotherapy, if indicated.

Group II: Non-Adaptive ArmActive Control3 Interventions

Subjects in this arm will receive their radiotherapy using standard image-guided radiation therapy (IMRT) techniques. All subjects will receive standard concurrent chemotherapy and may receive adjuvant immunotherapy, if indicated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chemotherapy

2003

Completed Phase 4

~3050

Adaptive Radiotherapy

2007

Completed Phase 2

~160

Immunotherapy

2016

Completed Phase 4

~1530

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, which kills rapidly dividing cancer cells; targeted therapy, which blocks specific molecules involved in cancer growth and spread; immunotherapy, which boosts the body's immune system to fight cancer; and radiotherapy, which uses high-energy radiation to destroy cancer cells. Daily Online Adaptive Radiotherapy, a form of radiotherapy, adjusts the radiation treatment plan based on daily imaging to better target the tumor and spare normal tissues. This approach is particularly important for NSCLC patients as it can reduce acute respiratory and esophageal toxicity, improving the overall safety and effectiveness of the treatment.