What side effects are associated with this type of intervention?

Common treatments for lung cancer, such as Stereotactic Body Radiation Therapy (SBRT), Image-Guided Radiation Therapy (IGRT), chemotherapy, and immunotherapy, have various side effects. SBRT and IGRT, known for their precision, can cause fatigue, skin irritation, and localized pain. Chemotherapy drugs like cisplatin, carboplatin, paclitaxel, pemetrexed, and etoposide often lead to nausea, vomiting, hair loss, and increased infection risk due to bone marrow suppression. Immunotherapy with durvalumab may result in immune-related side effects, including inflammation of the lungs, liver, and other organs. Combining these treatments can intensify these side effects, requiring careful management.

What prior FDA approvals exist?

The FDA has approved several treatments for lung cancer that align with the principles of high precision and targeted therapy, similar to Stereotactic Body Radiation Therapy (SBRT). SBRT itself is a recognized treatment modality for early-stage non-small cell lung cancer (NSCLC) and is particularly beneficial for patients who are not candidates for surgery. Additionally, the FDA has approved various systemic therapies that can be used in conjunction with radiation, such as immunotherapy agents like durvalumab, which is used after chemoradiotherapy in patients with stage III NSCLC. These treatments aim to enhance the precision and efficacy of lung cancer management while minimizing collateral damage to healthy tissues.

What other types of research exist?

Promising novel alternatives to SBRT for lung cancer patients include: 1) Intensity-Modulated Radiation Therapy (IMRT), which offers precise targeting with reduced side effects; 2) Proton Beam Therapy, which minimizes radiation exposure to surrounding tissues; 3) Central Nervous System-Penetrant Tyrosine Kinase Inhibitors (TKIs) like alectinib and ceritinib for specific genetic mutations (e.g., ALK-positive NSCLC); and 4) Immunotherapy with agents like durvalumab, which can enhance the body's immune response against tumor cells.

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Chemotherapy

High-Dose Radiation + Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer

Phase 3

Recruiting

Led By Charles B Simone

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

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

Must have

Presence of identified primary tumor and at least one nodal metastasis

Subjects with non-malignant pleural effusion are eligible provided the effusion is not known or demonstrated to be an exudative effusion

Must not have

Participants who are pregnant or unwilling to discontinue nursing

Patients without identifiable primary tumor and at least 1 pathologically enlarged lymph node are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests whether adding a precise form of radiation therapy to the usual treatment improves outcomes for patients with advanced lung cancer that can't be operated on. The goal is to see if this combination helps patients live longer and prevents cancer from worsening. This form of radiation therapy has shown promise in improving survival rates in patients with various stages of lung cancer.

Who is the study for?

Adults aged 18+ with stage II or III non-small cell lung cancer (NSCLC) that can't be surgically removed, but haven't had extensive prior treatment. They must have a performance status indicating they're still fairly active and able to care for themselves. Participants need functioning organs, no serious concurrent illnesses, and if of childbearing potential, agree to use contraception.

What is being tested?

The trial is testing whether adding high-dose targeted radiation (SBRT) to the usual combination of image-guided radiation therapy (IGRT), chemotherapy drugs like cisplatin or carboplatin with paclitaxel, pemetrexed or etoposide, followed by immunotherapy drug durvalumab improves outcomes in inoperable NSCLC compared to standard treatment alone.

What are the potential side effects?

Possible side effects include damage to surrounding healthy tissue from radiation; nausea, kidney issues from platinum-based chemo drugs; nerve problems from paclitaxel; immune-related reactions from durvalumab such as inflammation in various organs; fatigue and blood count changes.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has spread to at least one lymph node.

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My lung fluid buildup is not due to cancer.

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My blood counts are good enough for chemotherapy and radiation.

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I can take care of myself and perform daily activities.

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My cancer has EGFR or ALK mutations.

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I am 18 years old or older.

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My primary tumor is 7 cm or smaller.

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My lung cancer is stage II or III and I know my PD-L1 status.

Exclusion Criteria

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

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I am not pregnant and not nursing.

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I do not have cancer that started in an unknown place with a swollen lymph node.

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My main tumor is very close to the affected lymph nodes.

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I've had radiation in the same area as my current cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 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

Overall Survival (OS)

Progression-Free Survival (PFS)

Secondary study objectives

Changes in pulmonary function

Incidence of adverse events

Objective Response Rate (ORR)

+3 more

Other study objectives

Functional mean lung dose

Incidence of toxicities

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 II (SBRT, image guided RT, chemotherapy, immunotherapy)Experimental Treatment12 Interventions

Patients undergo SBRT and conventional IGRT and receive standard of care chemotherapy consisting of paclitaxel IV and carboplatin IV or pemetrexed IV and carboplatin IV or etoposide IV and cisplatin IV or pemetrexed IV and cisplatin IV and then receive durvalumab IV on study. Patients also undergo CT and/or PET/CT during follow up.

Group II: Arm I (image guided RT, chemotherapy, immunotherapy)Active Control11 Interventions

Patients undergo conventional IGRT and receive standard of care chemotherapy consisting of paclitaxel IV and carboplatin IV or pemetrexed IV and carboplatin IV or etoposide IV and cisplatin IV or pemetrexed IV and cisplatin IV and then receive durvalumab IV on study. Patients also undergo CT and/or PET/CT during follow up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Paclitaxel

2011

Completed Phase 4

~5450

Image Guided Radiation Therapy

2016

Completed Phase 2

~20

Pemetrexed

2014

Completed Phase 3

~5550

Carboplatin

2014

Completed Phase 3

~6120

Cisplatin

2013

Completed Phase 3

~3120

Computed Tomography

2017

Completed Phase 2

~2740

Durvalumab

2017

Completed Phase 2

~3750

Etoposide

2010

Completed Phase 3

~2960

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~790

0 / 12Eligibility 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

Stereotactic Body Radiation Therapy (SBRT) is a high-precision radiation treatment that targets lung cancer tumors with high doses of radiation over fewer sessions, minimizing damage to surrounding healthy tissue. This precision is crucial for lung cancer patients as it reduces side effects and improves the quality of life while effectively controlling tumor growth. Chemotherapy, using drugs like cisplatin and carboplatin, works by killing or inhibiting the growth of rapidly dividing cancer cells, but it can also affect normal cells, leading to broader side effects. Immunotherapy, such as durvalumab, enhances the body's immune response against cancer cells, offering a targeted approach that can lead to prolonged survival. Combining these treatments can provide a comprehensive approach to managing lung cancer, balancing efficacy with quality of life.

Stereotactic body radiotherapy for centrally located early-stage non-small cell lung cancer or lung metastases from the RSSearch(®) patient registry.