New Treatment for Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Other cancer, Pregnancy, Lactation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2 years

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for multifocal lung adenocarcinoma?

The research highlights that multifocal lung adenocarcinoma is a unique type of lung cancer with a slower progression and less likelihood of spreading compared to other types. This suggests that treatments targeting its specific characteristics may be effective, although direct evidence for the new treatment's effectiveness is not provided. ^{1 2 3 4 5}

What safety data exists for the new lung cancer treatment?

The safety of PD-1/PD-L1 inhibitors, used in treating non-small cell lung cancer, has been studied, showing they can improve survival but may cause side effects like skin, stomach, lung, and heart issues. Monitoring for these side effects is important during treatment. ^{6 7 8 9 10}

What makes the new treatment for multifocal lung adenocarcinoma unique?

The new treatment for multifocal lung adenocarcinoma is unique because it may involve targeted therapy based on specific genetic mutations, such as the KIAA1468-RET fusion gene, which can be identified through advanced genetic testing. This approach allows for personalized treatment strategies that are more effective for individual patients compared to standard therapies. ^{1 2 3 9 11}

What is the purpose of this trial?

To gather preliminary safety and outcome data for the multimodality treatment of lung adenocarcinoma in the setting of multifocal BAC.

Research Team

Dennis A. Wigle

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults over 18 with multifocal lung adenocarcinoma, no distant metastases, and capable lungs for surgery. It's not for pregnant women or those who've had other cancers (except certain early-stage ones), prior chest radiation, chemotherapy, or lung cancer surgery.

Inclusion Criteria

You are not diagnosed with cancer that has spread to nearby lymph nodes.

I am older than 18 years.

My cancer has not spread to distant parts of my body.

Exclusion Criteria

I have two or more lesions that may indicate my disease is in multiple places.

I haven't had radiation therapy in my chest area for lung cancer.

I haven't had any cancer in the last 5 years, except for early prostate cancer or skin basal cell.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multimodality treatment including aggressive local and targeted systemic therapy, informed by tumor genome sequencing

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pulmonary function testing and survival assessments

2 years

Every 3 months

Treatment Details

Interventions

• Multifocal Lung Adenocarcinoma

Trial Overview The study aims to evaluate the safety and outcomes of a combined treatment approach for patients with multifocal bronchioloalveolar carcinoma (BAC), a form of non-small cell lung cancer.

Participant Groups

Group I: Multifocal Lung Adenocarcinoma Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

Recent advancements in pharmacogenomics have led to the development of novel agents for treating non-small cell lung cancer adenocarcinoma, emphasizing the importance of testing for specific mutations like EGFR and ALK in clinical practice.

Immunotherapy, particularly with agents like nivolumab and pembrolizumab, has emerged as a promising treatment for advanced non-small cell lung cancer, although monitoring for adverse effects is crucial during patient follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Possible adverse effects of immunotherapy in non-small cell lung cancer; treatment and follow-up of three cases. Zarogoulidis, P., Chinelis, P., Athanasiadou, A., et al.[2020]

In a phase II trial involving 88 chemotherapy-naive patients with advanced adenocarcinoma with bronchioloalveolar carcinoma subtype (ADC-BAC), gefitinib achieved a disease control rate of 29.4%, indicating its efficacy as a first-line treatment.

Gefitinib was associated with low toxicity, with common side effects including dermatological issues, diarrhea, and nausea, making it a suitable option for patients, especially those with the nonmucinous subtype of ADC-BAC, who showed better progression-free and overall survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IFCT-0401 Trial: a phase II study of gefitinib administered as first-line treatment in advanced adenocarcinoma with bronchioloalveolar carcinoma subtype. Cadranel, J., Quoix, E., Baudrin, L., et al.[2018]

Targeted therapies for non-small cell lung cancer (NSCLC) have significantly improved treatment options, but their effectiveness can be compromised by issues like poor patient adherence and adverse events.

The review highlights the need for standardized monitoring protocols for the various toxicities associated with these therapies, which can include skin, gastrointestinal, lung, and heart-related side effects, to ensure better patient management and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted Toxicities: Protocols for Monitoring the Adverse Events of Targeted Therapies Used in the Treatment of Non-Small Cell Lung Cancer. Hines, JB., Bowar, B., Levine, E., et al.[2023]

In a meta-analysis of 4413 patients from 8 randomized controlled trials, PD-1/PD-L1 inhibitors showed a significantly lower risk of all-grade adverse events (66.20% vs. 86.08%) and high-grade adverse events (14.26% vs. 43.53%) compared to chemotherapy, indicating a better safety profile.

While PD-1/PD-L1 inhibitors are generally safer, they are associated with a unique set of immune-related adverse events (irAEs) that can be severe, such as pneumonitis and thyroid dysfunction, which clinicians need to monitor closely to manage patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of PD-1/PD-L1 inhibitors in the treatment of non-small cell lung cancer: a meta-analysis of randomized controlled trials. Luo, W., Wang, Z., Tian, P., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Lesions in patients with multifocal adenocarcinoma are more frequently in the right upper lobes. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Progress in genome-inspired treatment decisions for multifocal lung adenocarcinoma. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Management of Multifocal Lung Cancer: Results of a Survey. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Resection of multifocal non-small cell lung cancer when the bronchioloalveolar subtype is involved. [2019]

5. China pubmed.ncbi.nlm.nih.gov

[Study on Clinicopathological Features and Prognostic Factors of Multifocal Lung Cancer]. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Possible adverse effects of immunotherapy in non-small cell lung cancer; treatment and follow-up of three cases. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

IFCT-0401 Trial: a phase II study of gefitinib administered as first-line treatment in advanced adenocarcinoma with bronchioloalveolar carcinoma subtype. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Targeted Toxicities: Protocols for Monitoring the Adverse Events of Targeted Therapies Used in the Treatment of Non-Small Cell Lung Cancer. [2023]

9. Singapore pubmed.ncbi.nlm.nih.gov

Molecular characteristics of multifocal invasive mucinous adenocarcinoma of the lung: Report of a rare case. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

Safety and tolerability of PD-1/PD-L1 inhibitors in the treatment of non-small cell lung cancer: a meta-analysis of randomized controlled trials. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Clonality of multifocal nonsmall cell lung cancer: implications for staging and therapy. [2018]