Recruiting

Neoadjuvant Chemo-immunotherapy

Sponsor:

Scientific Institute San Raffaele

Code:

NCT06626243

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The study is a retrospective observational study. The study is designed to be multicentric and international and it will analyze medical records from selected patients diagnosed with locally advanced and resectable NSCLC who underwent lung resection by robotic, VATS and open approach after receiving neoadjuvant chemo-immunotherapy.

There are no risks for the patients, as this is a retrospective data collection.

Conditions

Non-Small Cell Lung Cancer

Study ID

NCT06626243

Start date

Sep 30, 2024

Status verified date

Nov, 2024

Completion date

Oct 15, 2025

Anticipated

Primary completion date

Feb 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of clinical or pathological stage IIB (T1-2, hilar N1, M0) and III (any T, N1-2, M0) NSCLC surgically treated with robotic, VATS and open approach with radical intent from 1st of January 2016 to 31st of March 2024
  • Received neoadjuvant chemo-immunotherapy or immunotherapy alone
  • Age >= 18 years old at the moment of surgery

Exclusion Criteria:

  • Age <18 years old at the moment of surgery

Study Design

Enrollment

140 participants

Anticipated

Interventions and Outcome Measures

Arms

Robotic Approach

Adult patients diagnosed with locally advanced and resectable non-small cell lung cancer (NSCLC) who underwent robotic lung resection

video-assisted thoracoscopic surgery (VATS) Approach

Adult patients diagnosed with locally advanced and resectable non-small cell lung cancer (NSCLC) who underwent video-assisted thoracoscopic surgery (VATS) lung resection

Open Approach

Adult patients diagnosed with locally advanced and resectable non-small cell lung cancer (NSCLC) who underwent open lung resection

Primary outcome measure

  • The perioperative complication of video-assisted thoracoscopic surgery (VATS) approach [ Time Frame: 30-90 days after surgery ]
  • The perioperative complications of robotic approach [ Time Frame: from the surgery at 30-90 days after ]
  • The perioperative complications of the open approach [ Time Frame: 30-90 days after surgery ]

Central Contacts and Locations

Central contacts

Pierluigi Novellis, Medical Doctor

0226437202novellis.pierluigi@hsr.it

Locations

Baptist Health South Florida

Recruiting

Miami, Florida, United States, 33176

Contacts

Mark R. Dylewski, MD

MarkD@baptisthealth.net

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Bernard J. Park, MD

parkb@mskcc.org

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Alper Toker, MD

alper.toker@wvumedicine.org

More Information

Sponsor

Scientific Institute San Raffaele

Last update posted

Nov 29, 2024

Last verified

Nov, 2024

Keywords

  • Video-Assisted Thoracoscopic Surgery
  • Robot-Assisted Thoracoscopic Surgery
  • open approach

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Scientific Institute San Raffaele on 2024-11-29.