ClinicalTrials.gg
RecruitingNCT06038227LARCSUpdated Sep 14, 2026

Lung cAncer Robotic Comparative Study

An observational study in Lung Cancer, sponsored by Intuitive Surgical. Recruiting at 13 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Intuitive Surgical · Observational

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Study summary

To compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer.

Read the detailed description

Detection of lung cancer is occurring at increasingly earlier stages due to improved screening and the discovery of incidental nodules. Coinciding with this trend is recent data from two international randomized, control trials, RAVAL - (Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer) and, JCOG0802 (The Japan Clinical Oncology Group) that show oncologic outcomes from segmentectomy are equivalent to lobectomy for cancers ≤2 cm. However, segmentectomy is a more complex technical operation that may not be easily feasible using video assisted thoracic surgery (VATS) but could be facilitated by robotic-assisted thoracic surgery (RATS), allowing improved vision, precision and controlled anatomic dissection.

The LARCS study is designed to understand the perioperative outcomes of patients and identify the real-world selection process of either VATS and RATS segmentectomy and lobectomy for lung cancers ≤2 cm. It aims to generate evidence to support integration of patient-centered care using minimally invasive technology.

In addition, health related quality of life captured in the study will also provide valuable insight into time to recovery, determining burden of the disease, and guide future treatment strategy.

02

Conditions studied

  • Lung Cancer

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Keywords

  • Minimally invasive surgery
  • Robotics
03

In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 600 is above the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Intuitive Surgical is the lead sponsor of 62 studies on the registry; 6 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Data from adult participants who have a lobectomy or segmentectomy for treatment of non small cell lung cancer (clinical stages IA1-2) will be collected.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient diagnosed with clinical stage IA1-2 non-small cell lung cancer at time of procedure
  • Patient scheduled to undergo minimally invasive surgery for NSCLC with either da Vinci robotic assisted surgery or VATs
  • Aged ≥ 18 years
  • Must be willing and able to comply with study requirements
  • Must indicate their understanding of the study and willingness to participate by signing an appropriate form

Exclusion criteria

Exclusion Criteria:

  • Patients with clinical stage IA3, II, III, and IV lung cancer
  • Patient receiving a lobectomy/segmentectomy as an emergency procedure
  • Patients receiving a lobectomy/segmentectomy for cancer
  • Patients scheduled to receive a bilobectomy or sleeve-lobectomy
  • Mental incapacity to understand or consent to study procedures
  • Anticipated difficulty for patient to comply with protocol requirements
  • Unable to comply with the follow up schedule
  • Pregnant or are planning to become pregnant during the study
  • \< 12 months
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No

Groups and cohorts

  • Robotic Assisted Thoracic Surgery

    Participants will undergo robotic assisted thoracic surgery (RATS) for segmentectomy or lobectomy.

    Procedure: Robotic Assisted Thoracic Surgery

  • Video Assisted Thoracic Surgery

    Participants will undergo video assisted thoracic surgery (VATS) for segmentectomy or lobectomy.

    Procedure: Video Assisted Thoracic Surgery

Interventions

  • ProcedureRobotic Assisted Thoracic Surgery

    Surgeons will pre-determine to perform a segmentectomy or lobectomy using RATS.

  • ProcedureVideo Assisted Thoracic Surgery

    Surgeons will pre-determine to perform a segmentectomy or lobectomy using VATS.

06

What researchers measure

Primary outcomes

  1. Patient reported Quality of Life 1

    EQ 5D 5L (European Quality of Life Five Dimension) The EQ-5D-5L is a validated and established generic Patient Reported Outcome (PRO) instrument that uses 6 questions to assess patients' quality of life. It includes a vertical EQ visual analog scale (EQ VAS, 0-100 points) and a descriptive EQ-5D-5L system. An algorithm is used to calculate the scores. For the descriptive section of the scale, an index value of 1 represents the best possible health state, while an index value of \<0 (variable) represents the worst possible health state. The EQ VAS score is rated on a scale of 0-100 points. 0 points correspond to the worst possible health status, while 100 points correspond to the best possible health status.

    Time frame: 1 month post surgery

  2. Patient reported Quality of Life 2

    RNLI (Reintegration to Normal Living Index) The RNLI has 11 questions and is scored on a visual analogue scale (VAS). On one end: "does not describe my situation" (1 or minimal integration) and "fully describes my situation" (10 or complete integration). Individual item scores are summed to provide the total score. The higher the score, the better the patients perceived integration.

    Time frame: 1 month post surgery

Secondary outcomes

  1. Number of conversions from pre-operative surgical plan

    Number of participants who undergo conversion surgery from the pre-operative surgical plan captured on the surgical decision making form. Conversion may be from segmentectomy to lobetomy, RATS or VATS to open surgery.

    Time frame: immediately post operative

07

Study locations

13 of 13 sites recruiting
  • Copenhagen University Hospital Rigshospitalet
    Copenhagen, Denmark
    Recruiting
    • Rene Petersen · Contact
    • Rene Petersen · Principal investigator
  • AP-HM
    Marseille, France
    Recruiting
    • Pascal-Alexandre THOMAS · Contact
    • Pascal-Alexandre Thomas · Principal investigator
  • CHU de Rouen
    Rouen, France
    Recruiting
    • Jean Marc Baste · Contact
    • Jean-Marc Baste · Principal investigator
  • CHU de Toulouse
    Toulouse, France
    Recruiting
    • Laurent Brouchet · Contact
    • Laurent Brouchet · Principal investigator
  • Thoraxklinik
    Heidelberg, Germany
    Recruiting
    • Martin Eichhorn · Contact
    • Martin Eichhorn · Principal investigator
  • Krankenhaus Barmherzige Brüder
    Regensburg, Germany
    Recruiting
    • Hans-Stefan Hofmann · Contact
    • Hans-Stefan Hofmann · Principal investigator
  • Azienda Ospedaliero Universitaria Pisana
    Pisa, Italy
    Recruiting
    • Carmelina Cristina, Zirafa · Contact
    • Carmelina Cristina Zirafa · Principal investigator
  • Akershus University Hospital
    Loerenskog, Norway
    Recruiting
    • Rune, Eggum · Contact
    • Rune Eggum · Principal investigator
  • University Hospital Zurich
    Zurich, Switzerland
    Recruiting
    • Isabelle Schmitt-Opitz · Contact
    • Isabelle Schmitt-Opitz · Principal investigator
  • University Hospitals Bristol and Weston NHS Foundation Trust
    Bristol, United Kingdom
    Recruiting
    • Igor Saftic · Contact
    • Igor Saftic · Principal investigator
  • University Hospitals Coventry and Warwickshire NHS Trust
    Coventry, United Kingdom
    Recruiting
    • Luis Hernandez · Contact
    • Luis Hernandez · Principal investigator
  • Guy's and St Thomas' NHS Foundation Trust
    London, SE1 9RT, United Kingdom
    Recruiting
    • Tom Routledge · Contact
    • Tom Routledge · Principal investigator
  • St Bartholomew Hospital
    London, United Kingdom
    Recruiting
    • Steven Stamenkovic · Contact
    • Steven Stamenkovic · Principal investigator
08

References and documents

Publications

  • Patel YS, Hanna WC, Fahim C, Shargall Y, Waddell TK, Yasufuku K, Machuca TN, Pipkin M, Baste JM, Xie F, Shiwcharan A, Foster G, Thabane L. RAVAL trial: Protocol of an international, multi-centered, blinded, randomized controlled trial comparing robotic-assisted versus video-assisted lobectomy for early-stage lung cancer. PLoS One. 2022 Feb 2;17(2):e0261767. doi: 10.1371/journal.pone.0261767. eCollection 2022. PubMed 35108265 ↗
  • Saji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, Aoki T, Okami J, Yoshino I, Ito H, Okumura N, Yamaguchi M, Ikeda N, Wakabayashi M, Nakamura K, Fukuda H, Nakamura S, Mitsudomi T, Watanabe SI, Asamura H; West Japan Oncology Group and Japan Clinical Oncology Group. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial. Lancet. 2022 Apr 23;399(10335):1607-1617. doi: 10.1016/S0140-6736(21)02333-3. PubMed 35461558 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2023 (actual). Primary completion is estimated for Dec 2027, 53 months after the start.

Of 90 industry-sponsored observational studies under Lung Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 58. This study's planned 53 months is above that.

Counting every sponsor, half of 681 studies reached it within 57 months; a quarter within 25 and three quarters within 135.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2023
First posted
Sep 14, 2023
StartActual
Jul 15, 2023
Primary completionEst.
Dec 30, 2027
CompletionEst.
Dec 30, 2027
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06038227
Lead sponsor
Intuitive Surgical
Responsible party
Sponsor
First posted
Sep 14, 2023
Start date
Jul 15, 2023
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Sep 14, 2026

Study contacts

Marie Allouis
Contact
Marie.Allouis@intusurg.com
+33786480495
James Grainger
Contact
james.grainger@intusurg.com
Tom Routledge
principal investigator · Guy's St Thomas' NHS Foundation Trust, UK
Rune Eggum
principal investigator · University Hospital, Akershus
Martin Eichhorn
principal investigator · Thoraxklinik Heidelberg, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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