Clinical and Molecular Findings in Patients With Cervical/Supraclavicular Metastasis From Non-small-cell Lung Cancer (NSCLC) (ProphetaPro)

Mutational Profile of Patients With and Without Neck and Supraclavicular Lymph Nodes Metastasis From Advanced Non-squamous Non-small-cell Lung Cancer: a Prospective Cohort Study

Despite the availability of highly effective endoscopy-based and computed tomography (CT)-based biopsy procedures, up to 50% of patients with advanced lung cancer potentially eligible for targeted therapies or immunotherapy do not have access to a diagnosis or to a thorough molecular profiling for different reasons. Enlarged and/or positron emission tomography (PET) positive cervical/supraclavicular lymph nodes (CSLs) are ideal targets for a minimally invasive diagnosis of lung cancer through a percutaneous ultrasound-guided biopsy (US-NAB). However, the prevalence of metastatic involvement of CSLs in patients with advanced lung cancer was never specifically assessed. Furthermore, the possible association of malignant CSLs involvement with molecular status was never investigated, unlike what was done for several other metastatic sites.

Study Overview

• Status: Completed
• Conditions: Lung Cancer Metastatic
• Intervention / Treatment: Procedure: Needle or forceps biopsy of cervical and/or supraclavicular lymph nodes; Procedure: Needle, forceps or surgical biopsy of any lesion other than cervical and/or supraclavicular lymph nodes

• Study Type: Observational
• Enrollment (Actual): 348

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Patients with clinical and radiological suspicion of advanced lung cancer

Description

Inclusion Criteria:

• Age >18 years at the time of the procedure;
• Suspected advanced, treatment naïve non-squamous NSCLC ;
• Indication to biopsy for diagnosis and/or molecular profiling;
• Written informed consent to the study participation.

Exclusion Criteria:

• Patients with known non-squamous NSCLC sent for re-biopsy after first or second line treatment;
• Inability to stop anticoagulant or antiplatelet therapy before the procedure (except acetylsalicylic acid 100 mg/day);
• Platelet count <50.000 per μL;
• Inability or unwillingness to provide a written informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental group; Patients with advanced lung cancer featuring cervical and/or supraclavicular lymph node metastasis	Procedure: Needle or forceps biopsy of cervical and/or supraclavicular lymph nodes; Patients with evidence of enlarged and/or PET positive cervical and/or supraclavicular lymph nodes suspected of being metastasis from lung cancer will be submitted to the biopsy from this location.; Other Names: Ultrasound guided biopsy
Control group; Patients with advanced lung cancer NOT featuring cervical and/or supraclavicular lymph node metastasis	Procedure: Needle, forceps or surgical biopsy of any lesion other than cervical and/or supraclavicular lymph nodes; Patients without evidence of enlarged and/or PET positive cervical and/or supraclavicular lymph nodes will be submitted to the biopsy considered less invasive and effective based on imaging data and clinical health status.; Other Names: Ultrasound guided biopsy; Forceps biopsy during bronchoscopy; Surgical biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of KRAS mutation	Number of participants with KRAS mutation in the 2 groups (patients with and without cervical/supraclavicular lymph node metastasis)	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of EGFR, ALK, ROS1, BRAF, RET, MET, NTRK	Number of participants with EGFR, ALK, ROS1, BRAF, RET, MET, NTRK mutation in the 2 groups (patients with and without cervical/supraclavicular lymph node metastasis)	2 months
Tumor proportion score of PD-L1	Number of participants with a tumor proportion score of PD-L1 < 1%; 1-50%; >50% in the two groups (patients with and without cervical/supraclavicular lymph node metastasis)	2 months
Prevalence of cervical/supraclavicular lymph node metastasis	Number of participants with cervical/supraclavicular lymph node metastasis in the whole cohort of patients with stage IV lung cancer	2 months
Predictors of cervical/supraclavicular lymph node metastasis	Association between the presence of cervical/supraclavicular lymph node metastasis and the following factors: age, sex, smoking habit, tumor histologic type, central vs peripheral primary tumor, enlarged and/or PET positive N2 or N3 lymph nodes in the middle mediastinum, and molecular profile.	6 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Rocco Trisolini, MD, Fondazione Policlinico Universitario A. gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 5394

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No