Treatment of Multifocal Lung Adenocarcinoma

A Clinical Pathway for the Treatment of Multifocal Lung Adenocarcinoma Using Genome Sequencing

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

Study Overview

• Status: Terminated
• Conditions: Adenocarcinoma; Lung Neoplasms; Carcinoma Non-small-cell Lung
• Intervention / Treatment: Genetic: Multifocal Lung Adenocarcinoma

Detailed Description

Lung bronchoalveolar carcinoma (BAC) or adenocarcinoma in situ (AIS) continues to represent a poorly understood clinical entity. A frequent clinical dilemma in lung cancer care is the management of a documented or suspected invasive adenocarcinoma in the setting of multifocal ground glass opacity (GGO) consistent with multifocal AIS. These patients are typically classified as stage IV disease, and treated with palliative chemotherapy. No existing pathologic or molecular test is currently capable of making the distinction between independent primary versus metastatic tumors, a distinction for which substantial treatment impact exists. Many treating physicians suspect that outcomes for this specific patient subgroup are better than norms for stage IV disease, as such patients are frequently node-negative and without distant metastases despite multiple lesions present. To address this issue, we will evaluate a multimodality treatment protocol using aggressive local and targeted systemic therapy for multifocal lung adenocarcinoma, incorporating information from tumor genome sequencing for individualized treatment planning. The results will have significant impact in advancing the biologic understanding and treatment approach for lung adenocarcinoma in the setting of multifocal AIS.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• Patient must be > 18 years of age
• Two or more GGO's or solid lesions suspicious for multifocal disease.
• Clinical diagnosis of N0
• No evidence of distant metastases
• No prior intra-thoracic radiation therapy (NOTE: Previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted.), previous chemotherapy, or surgical resection for non-small cell lung cancer (NSCLC).
• No other cancer in the past 5 years except early stage prostate cancer, or basal cell of skin.
• PFT's that show patient is capable of tolerating a lung resection.
• Non-pregnant and non-lactating. Women of child-bearing potential must have a negative urine or serum pregnancy test to participate in the study.
• Patient must be able to understand and willing to sign an IRB-approved informed consent document.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Multifocal Lung Adenocarcinoma	Genetic: Multifocal Lung Adenocarcinoma; Tissue collection at the time of surgery for genetic testing and blood sample for germ line DNA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall survival compared to survival for Stage IV NSCLC on NCCTG trials	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progressive free survival	Progressive free survival	Every 3 months for 2 years
Treatment Morbidity and Mortality	Treatment Morbidity and Mortality	2 years
Post-treatment Pulmonary Function	Post-treatment Pulmonary Function measured by pulmonary function testing (spirometry)	2 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Dennis Wigle, MD, PhD, Mayo Clinic

Publications and helpful links

General Publications

• Saddoughi SA, Powell C, Stroh GR, Rajagopalan S, Bartholmai BJ, Boland JM, Aubry MC, Harmsen WS, Blackmon SH, Cassivi SD, Nichols FC, Reisenauer JS, Shen KR, Mansfield AS, Maldonado F, Peikert T, Wigle DA. Long-Term Survival and CANARY-Based Artificial Intelligence for Multifocal Lung Adenocarcinoma. Mayo Clin Proc Digit Health. 2024 Jan 11;2(1):44-52. doi: 10.1016/j.mcpdig.2023.10.006. eCollection 2024 Mar.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2013
• Primary Completion (Actual): May 29, 2025
• Study Completion (Actual): May 29, 2025

Study Registration Dates

• First Submitted: September 16, 2013
• First Submitted That Met QC Criteria: September 18, 2013
• First Posted (Estimated): September 19, 2013

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: genetic; multifocal; next generation sequencing; bronchoalveolar carcinoma; adenocarcinoma in situ; ground glass opacity
• Additional Relevant MeSH Terms: Adenocarcinoma of Lung; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma in Situ; Pathological Conditions, Signs and Symptoms; Morphological and Microscopic Findings; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Adenocarcinoma, Bronchiolo-Alveolar; Adenocarcinoma in Situ
• Other Study ID Numbers: 12-007569

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No