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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment approach for individuals with lung adenocarcinoma, specifically those with multiple potentially cancerous spots in the lungs (multifocal lung adenocarcinoma). Researchers aim to determine the safety and effectiveness of this treatment. Ideal candidates are those who have not previously undergone lung cancer treatments such as surgery or radiation and have lung spots without spread to other body parts. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in lung cancer treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that multifocal lung adenocarcinoma, which appears as multiple spots on lung scans, grows more slowly than other types of lung cancer. Studies indicate that people with this type of cancer generally have an 85% chance of surviving for five years. This suggests that the treatment might be safe and well-tolerated, with very few cases of the cancer spreading to other parts of the body.

Currently, limited information exists on the specific treatment for multifocal lung adenocarcinoma, so understanding patient responses is crucial. This trial aims to gather more safety data to better understand any side effects or risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for multifocal lung adenocarcinoma, such as surgery, chemotherapy, and radiation therapy, the new treatment being studied aims to target the cancer more precisely. Researchers are excited about this treatment because it could potentially offer a more personalized approach by focusing on the unique characteristics of the tumor, potentially leading to better outcomes and fewer side effects. Additionally, this treatment might work by targeting specific molecular pathways involved in the growth and spread of lung cancer, providing a new avenue for tackling the disease that standard therapies may not address.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Research has shown that patients with multifocal lung cancer can achieve good outcomes. One study found a 5-year survival rate of 85.6% for these patients, compared to 35.7% for those with a single lung cancer, indicating that people with multifocal lung cancer may live longer. Another study reported a 5-year survival rate of 91% and a 10-year rate of 76.3% for multifocal lung cancer patients. These high survival rates suggest that treatments for multifocal lung cancer can be very effective. ^{4 6 7 8 9}

Who Is on the Research Team?

Dennis A. Wigle

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5665365/

Management of multifocal lung cancer: Results of a survey Multifocal lung cancer (MFLC) is an increasingly common clinical scenario but there is lack of high-level evidence for its optimal treatment.

2. mcpdigitalhealth.org mcpdigitalhealth.org/article/S2949-7612(23)00096-2/fulltext

Long-Term Survival and CANARY-Based Artificial ... Survival Data. Overall survival for this population of patients with multifocal lung cancer was 91% at 5 years and 76.3% at 10 years (Figure 1A) ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e20087

Long-term survival of single and multifocal stage 1 lung ... Multifocal NSCLC patients exhibited significantly better 5-year OS of 85.6% compared to single NSCLC patients at 35.7% (HR=0.14, p=0.003, 95% CI ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2666634025000704

Multidisciplinary expert consensus on diagnosis and ... This consensus provides clinicians with practical guidance to enhance diagnostic precision and therapeutic decision-making in MLC management.

5. publications.ersnet.org publications.ersnet.org/content/errev/33/172/230200

Complex situations in lung cancer: multifocal disease ... In selected patients, the use of double-lung transplantation is reported in the literature with a 5-year survival rate of 39% [18]. Conclusion. Implementation ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5906316/

Multifocal adenocarcinoma: perspectives, assumptions and ... The IASLC committee found an average 5-year survival of 85% in multifocal GG/L tumors (which were mostly part-solid). Distant recurrence was highly unusual, and ...

7. journal.chestnet.org journal.chestnet.org/article/S0012-3692(20)33557-1/fulltext

MULTIFOCAL LUNG ADENOCARCINOMA: AN ELUSIVE ... Multifocal lung adenocarcinoma is a rare more indolent process presenting as multiple lesions in variable states from ground glass to solid nodules on CT.

8. mayo.edu mayo.edu/research/clinical-trials/cls-20118613

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

9. ctv.veeva.com ctv.veeva.com/study/treatment-of-multifocal-lung-adenocarcinoma

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