What side effects are associated with this type of intervention?

Common treatments for lung cancer, particularly those involving radiation therapy and immunotherapy, can have several side effects. Radiation therapy, including techniques like SBRT and hypofractionated RT, may cause pneumonitis, esophagitis, fatigue, and skin reactions. Immunotherapy, such as durvalumab, can lead to adverse events like pneumonia, diarrhea, pneumonitis, rash, and pruritus. These treatments aim to control the tumor while managing side effects to maintain patient quality of life.

What prior FDA approvals exist?

Several FDA-approved treatments for lung cancer focus on generating an anti-tumoral immune response, similar to the goals of Non-ablative Oligofractionated Radiation Therapy (NORT). Pembrolizumab (Keytruda) and atezolizumab (Tecentriq) are notable immunotherapy drugs approved for advanced non-small cell lung cancer (NSCLC). These drugs work by inhibiting the PD-1/PD-L1 pathway, thereby enhancing the body's immune response against tumor cells. Additionally, durvalumab (Imfinzi) is approved for unresectable stage III NSCLC following chemoradiotherapy, leveraging the immune system to target cancer cells. These treatments, like NORT, aim to harness the body's immune system to fight cancer more effectively.

What other types of research exist?

Promising novel alternatives to Non-ablative Oligofractionated Radiation Therapy (NORT) for lung cancer patients include: 1) Alectinib dose escalation for patients with Anaplastic Lymphoma Kinase (ALK)-positive non-small cell lung cancer (NSCLC) relapsing on standard dose alectinib, which has shown to reinduce central nervous system responses. 2) Entrectinib for ROS1 fusion-positive NSCLC, which has demonstrated efficacy and safety in integrated analyses of phase 1-2 trials. 3) Lorlatinib for advanced ROS1-positive NSCLC, which has shown promising results in a multicenter, open-label, single-arm phase 1-2 trial. 4) Repotrectinib for advanced ROS1 fusion-positive NSCLC, which has shown preliminary clinical activity and safety in the TRIDENT-1 study. These therapies represent significant advancements in targeted treatments for specific genetic mutations in lung cancer.

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Radiation Therapy

Pre-Transplant Radiation for Lung Cancer (NORTh STAR Trial)

Q: What is the mechanism of action of this treatment?

Lung cancer treatments work through various mechanisms to target and eliminate cancer cells. Surgery physically removes tumors, which is effective for localized disease. Radiation therapy, including Non-ablative Oligofractionated Radiation Therapy (NORT), uses high-energy rays to destroy cancer cells and can stimulate an anti-tumoral immune response by creating heterogeneous dose distributions. Chemotherapy uses drugs to kill rapidly dividing cells, affecting both cancerous and healthy cells. Targeted therapy focuses on specific genetic mutations within cancer cells, minimizing damage to normal cells. Immunotherapy boosts the body's immune system to recognize and attack cancer cells. These treatments are crucial for lung cancer patients as they offer multiple strategies to control and potentially eradicate the disease, improving survival and quality of life.

N/A

Recruiting

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

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

Must have

Patients with end-stage lung disease and suspected stage I primary lung cancer based on CT and PET scan not accessible to curative treatment, including surgery and ablative SBRT.

Patients with isolated metastases in one or both lungs after complete resection of the primary tumor in the absence of other sites of metastatic disease, not accessible to curative treatment, including surgery and ablative SBRT.

Must not have

Age < 18

Mediastinal nodes metastasis demonstrated on EBUS-TBNA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to four years

Awards & highlights

No Placebo-Only Group

Summary

This trial involves giving short bursts of radiation to lung cancer tumors before a lung transplant. It targets patients with lung cancer who are getting a lung transplant. The radiation might help the body’s immune system recognize and fight the cancer, reducing the chance of it coming back after the transplant.

Who is the study for?

This trial is for adults over 18 with end-stage lung disease and suspected early-stage lung cancer, who are eligible for a lung transplant but can't have curative surgery. It's not for those with previous chest radiation, mediastinal node or distant metastasis, or other conditions that could affect participation.

What is being tested?

The study tests non-ablative oligofractionated radiation therapy (NORT) before lung transplantation to see if it's safe and can act as a 'radiovaccination', potentially reducing cancer recurrence by triggering an immune response against the tumor.

What are the potential side effects?

While specific side effects aren't listed here, NORT may cause typical radiation-related issues like skin changes at the treatment site, fatigue, inflammation of treated organs, and potential impacts on normal tissue near tumors.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is in early stage but can't be treated with surgery or targeted radiation.

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I had surgery to remove a lung tumor and have no other cancer spread that can be treated.

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I am 18 years old or older.

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I have multiple lung cancer spots that cannot be removed or cured with surgery or targeted radiation.

Exclusion Criteria

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

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I am under 18 years old.

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My cancer has spread to the lymph nodes in my chest, confirmed by a specific biopsy.

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My cancer has spread to distant parts of my body, confirmed by a scan.

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I've had chest radiation before that makes more radiation risky.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to four years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to four years

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

Maximum Tolerated Dose for Radiation

Secondary study objectives

Local recurrence

Patient Morbidity

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: Experimental: RadiationExperimental Treatment1 Intervention

Patients will be differentiated into 4 groups: 1. Patients with end-stage interstitial lung disease (ILD) and suspected stage I (up to 4 cm) primary lung cancer 2. Patients with end-stage lung disease other than ILD (e.g. emphysema/COPD, cystic fibrosis and pulmonary hypertension) and suspected stage I (up to 4 cm) primary lung cancer 3. Patients with multifocal primary lung cancer (e.g. multifocal adenocarcinoma) in the absence of nodal metastasis and distant metastasis. 4. Patients with isolated pulmonary metastasis in the absence of other sites of malignancy (primary and metastatic). For this study, different doses will be used for each different group depending on their tumour size. The first 3 patients will start with a dose of 4 Gy, for the ILD group, or 8 Gy, for the non ILD group. The doses are then increased incrementally until the dose limiting toxicity is reached.

0 / 8Eligibility 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

Lung cancer treatments work through various mechanisms to target and eliminate cancer cells. Surgery physically removes tumors, which is effective for localized disease. Radiation therapy, including Non-ablative Oligofractionated Radiation Therapy (NORT), uses high-energy rays to destroy cancer cells and can stimulate an anti-tumoral immune response by creating heterogeneous dose distributions. Chemotherapy uses drugs to kill rapidly dividing cells, affecting both cancerous and healthy cells. Targeted therapy focuses on specific genetic mutations within cancer cells, minimizing damage to normal cells. Immunotherapy boosts the body's immune system to recognize and attack cancer cells. These treatments are crucial for lung cancer patients as they offer multiple strategies to control and potentially eradicate the disease, improving survival and quality of life.

Optimize Local Therapy for Oligometastatic and Oligoprogressive Non-Small Cell Lung Cancer to Enhance Survival.