AzTrials
AzTrials

Non-Small Cell Lung CancerLidCRMNCT07347977

Lidocaine Decreases Postoperative Lung Cancer Reoccurance and Metatasis Risk

A study testing Lidocaine (drug) in people with Non-Small Cell Lung Cancer and Recurrence, run by First Affiliated Hospital of Ningbo University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to explore if perioperative lidocaine infusion decreases disease reoccurrence and metastasis risk in non-small cell lung cancer patients. Participants will be randomly assigned (1:1) to the lidocaine or placebo group. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Lidocaine (drug)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,400 participants
Where
1 siteChina
Study dates
1 Jan 2026to 30 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age range: 18-80 years old.
  • Electively undergo minimally invasive (thoracoscopic or robotic) surgery for the treatment of lung cancer
  • Is willing and capable of providing consent.

Who cannot join

  • Palliative surgery without intention of cure.
  • Extensive comorbidities (ASA IV).
  • Patients with known or suspected allergy to lidocaine.
  • Patients who are currently pregnant or breastfeeding.
  • Patients who may experience adverse reactions due to accumulation of lidocaine during intravenous infusion, as stated in the Summary of Product Characteristics (SmPC) for lidocaine.
  • Currently, there is abnormal liver function, with ALT or AST levels exceeding the laboratory reference range by a factor of 2.
Show all 12Show fewer
  • Currently, there is severe renal insufficiency (serum creatinine ≥451umol/L or glomerular filtration rate (calculated using the MDRD formula) <30ml/min).
  • Epilepsy.
  • Patients with cardiac conduction abnormalities, including second-degree or third-degree heart block without a pacemaker, left bundle branch block, sick sinus syndrome, and pre-excitation syndrome (confirmed by medical history and electrocardiogram), as well as those with low cardiac output due to reduced left ventricular ejection fraction.
  • Concurrent use with continuous infusion of other local anesthetic drugs (such as epidural).
  • Patients who use drugs that may cause reasons for exclusion, including Class I and Class III antiarrhythmic drugs (such as mexiletine and amiodarone), cimetidine, and antiviral drugs. Eligibility will be determined by local clinicians and verified by clinical trial doctors.
  • Patients with body weight <40kg

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Changshun Huang, MD contact

+8613957882779

fyyhuangchangshun@nbu.edu.cn

Yong Li contact

+8615168541165

yongli332603@163.com

China1 site

  • The first affiliated hospital of Ningbo University

    Ningbo, Zhejiang, 315000

Other trials in China

About this study

Official title: Lidocaine Infusion Decreases Postoperative Lung Cancer Reoccurance and Metatasis Risk: a Multicenter Randomized Controlled Study

The goal of this clinical trial is to explore if perioperative lidocaine infusion decreases disease reoccurrence and metastasis risk in non-small cell lung cancer patients.

Participants will be randomly assigned (1:1) to the lidocaine or placebo group. The intervention initiates within 30 minutes before anesthesia induction with an intravenous loading dose of 1.5 mg/kg administered over 10-20 minutes. This is followed by a continuous maintenance infusion of 1.5-3 mg/kg/h (calculated as 1-1.5 mg/kg/h in protocol text, see note below) during surgery, terminating 1 hour after skin closure. Participants will be followed up for 36 months post-surgery. Blood samples will be collected at baseline, postoperative day 1, day 3, and upon discharge

Read the detailed description
  1. Research design: This is a 1:1 parallel, double-blind (participants, investigators, and outcomes assessors) randomized controlled trial. Intravenous lidocaine or saline will be assigned to patients with lung cancer undergoing minimally invasive (thoracoscopic or robotic) surgery.
  2. Research Methods: 2.1. Intervention: 2% lidocaine hydrochloride or placebo (0.9% sodium chloride). 2.2. Dose planning: The intervention initiates within 30 minutes before anesthesia induction with an intravenous loading dose of 1.5 mg/kg (ideal body weight, IBW) administered over 10-20 minutes. This is followed by a continuous maintenance infusion of 1-1.5 mg/kg/h during surgery, terminating 1 hour after skin closure. The maximum infusion rate is capped at 120 mg/h. IBW is used to calculate dosage to prevent toxicity in overweight patients; however, for patients weighing less than their IBW, actual body weight is used. Patients in the placebo group receive the same volume and rate as the treatment group. Dose Guidelines Based on IBW (Broca Index): Males: height (cm) - 100; Females: height (cm) - 105. 2.3. Dose adjustment: No dosage changes are permitted. If systemic local anesthetic toxicity is suspected, the infusion must be stopped immediately and not resumed. Supportive care and lipid emulsion therapy will be provided. If infusion is interrupted due to mechanical issues (e.g., pump malfunction), it may be restarted at the original rate. 2.4. Additional care and procedures: To minimize confounding, general anesthesia will be maintained using a balanced technique. Postoperative care follows the unit's standard Enhanced Recovery After Surgery (ERAS) protocol. Concurrent continuous infusion of other local anesthetics (e.g., epidural or wound catheters) is prohibited during the IMP infusion period. 2.5. Postoperative analgesia management: After surgery, all patients will receive intravenous patient-controlled analgesia (or continuous infusion) with sufentanil (2 µg/kg diluted to 100 ml) at a background rate of 2 ml/h. 2.6. Sample size calculation: Based on a median recurrence-free survival (RFS) of 18 months in the control group and an expected extension to 24 months in the treatment group, the estimated Hazard Ratio (HR) is 0.75 (representing a 25% risk reduction). With a two-sided alpha of 0.05 and 90% power, 635 patients per group are required. Adjusting for a 10% dropout rate, the total sample size is set at 1400 patients (700 per group). 2.7. Randomization: Participants will be randomly assigned (1:1) using a minimization algorithm. Stratification factors include age (<45, 45-65, 65-80 years), gender, trial center, and pathological type of lung cancer.
  3. Efficacy evaluation criteria: The primary efficacy endpoint is Disease-Free Survival (DFS) within 36 months post-surgery. Chest CT scans will be performed at 6, 12, 18, 24, and 36 months to assess recurrence or metastasis. Additionally, the FACT-L questionnaire will be used to assess cancer-specific quality of life.
  4. Adverse events: The lidocaine dose and duration in this study align with international consensus statements on safety. The infusion is limited to the intraoperative period and ends 1 hour post-skin closure, minimizing accumulation risks. Safety monitoring will be conducted throughout the infusion. In the event of toxicity, lipid emulsion (20%) is available for immediate rescue following AAGBI guidelines.
  5. Quality control and quality assurance: SOPs will be strictly followed. Since the IMP infusion ends 1 hour after skin closure, monitoring will primarily occur in the operating room and PACU. Data will be recorded using EDC software. The investigators aim to collect outcome data for all randomized participants according to the intention-to-treat principle.
  6. Statistical analysis: Data will be analyzed using SPSS 21 based on the intention-to-treat (ITT) principle. Primary Analysis: The primary outcome (DFS at 36 months) will be analyzed using a multivariate Cox regression model to estimate the Hazard Ratio (HR) between the lidocaine and placebo groups, adjusting for covariates. Covariates: Age, gender, comorbidities, ASA classification, cancer stage, and neoadjuvant therapies. Survival Analysis: Kaplan-Meier curves and Log-rank tests will be used to compare survival distributions. Missing Data: Missing data will be handled using multiple imputation to ensure robustness.
  7. Ethics: The study adheres to the Declaration of Helsinki and local regulations. Ethics committee approval is required prior to initiation. Written informed consent will be obtained from all participants, ensuring they understand the risks and their right to withdraw. Privacy and data confidentiality will be strictly maintained.
Being tested
Lidocaine (drug)
Keywords
Lidocaine, Non-small cell lung cancer, Recurrence, Survival analysis
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lidocaine (drug)Drug

    Also called Lidocaine IV

    According to the random number table, grouping and coding are set, and the coding rules are predetermined by the statistical analyst. The intervention information is placed in a sealed opaque envelope and managed by an independent randomization specialist. After signing the informed consent form, the randomization specialist will configure drugs based on the grouping information and label them with codes, and hand them over to the anesthesiologist conducting blind intervention operations

Study groups in NCT07347977
Study groupRoleWhat they receive
lidocine infusion groupExperimentalLidocaine is administered intravenously at an ideal body weight (IBW) of 1.5 mg/kg starting from anesthesia induction, for 10-20 minutes, and then continuously infused at 1-1.5 mg/kg/h until 1 hour after skin closure, with a maximum rate of 120 mg/h. Use ideal weight instead of actual weight to prevent toxicity in very overweight patients. In patients with a weight lower than the ideal weight, the actual weight should be used to calculate the dose.
Receives: Drug: Lidocaine (drug)
normal saline groupPlacebo comparatorThe normal saline is administered at the volume calculated based on the equivalent volume of lidocaine dose according to body weight
Receives: Drug: Lidocaine (drug)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-Free Survival (DFS)

    DFS is defined as the time from the date of surgery to the first documentation of disease recurrence (including local recurrence, regional lymph node metastasis, or distant metastasis) or death from any cause.

    Measured: Up to 36 months after operation

Secondary outcomes (3)

  1. Overall Survival (OS)

    Overall survival is defined as the time from randomization to death from any cause

    Measured: 36month after operation

  2. EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)

    The EQ-5D-5L is used to assess health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

    The EQ-5D-5L index score is calculated using population-based preference weights and typically ranges from less than 0 (health states worse than death) to 1 (full health), with higher scores indicating better health-related quality of life.In addition, the EQ Visual Analogue Scale (EQ-VAS) records the participant's self-rated health on a vertical scale ranging from 0 (worst imaginable health) to 100 (best imaginable health), with higher scores indicating better perceived health.

    Measured: Baseline, Postoperative Day 1, Day 3, Discharge, and at 6, 12, 18, 24, 36 months post-surgery

  3. Cancer-specific quality of life measured using the Functional Assessment of Cancer Therapy - Lung (FACT-L)

    The FACT-L is a validated instrument that includes the Functional Assessment of Cancer Therapy - General (FACT-G) and a lung cancer-specific subscale. The total FACT-L score ranges from 0 to 136, with higher scores indicating better cancer-specific quality of life.

    Measured: Baseline, Postoperative Day 1, Day 3, Discharge, and at 6, 12, 18, 24, 36 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2026
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion30 Sep 2029 (estimated)
  4. Study completion30 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07347977
Sponsor's protocol ID
2025B024
Acronym
LidCRM
Status last verified
Jan 2026
First submitted
5 Dec 2025
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) may not be shared because the informed consent does not include provisions for public data sharing, and data are subject to institutional and ethical review restrictions.

Publications

  • Hiller JG, Perry NJ, Poulogiannis G, Riedel B, Sloan EK. Perioperative events influence cancer recurrence risk after surgery. Nat Rev Clin Oncol. 2018 Apr;15(4):205-218. doi: 10.1038/nrclinonc.2017.194. Epub 2017 Dec 28.

    PubMed 29283170

  • Ben-Eliyahu S, Golan T. Harnessing the Perioperative Period to Improve Long-term Cancer Outcomes. J Natl Cancer Inst. 2018 Oct 1;110(10):1137-1138. doi: 10.1093/jnci/djy055. No abstract available.

    PubMed 29718287

  • Wall TP, Buggy DJ. Perioperative Intravenous Lidocaine and Metastatic Cancer Recurrence - A Narrative Review. Front Oncol. 2021 Aug 2;11:688896. doi: 10.3389/fonc.2021.688896. eCollection 2021.

    PubMed 34408981

  • Zhang L, Hu R, Cheng Y, Wu X, Xi S, Sun Y, Jiang H. Lidocaine inhibits the proliferation of lung cancer by regulating the expression of GOLT1A. Cell Prolif. 2017 Oct;50(5):e12364. doi: 10.1111/cpr.12364. Epub 2017 Jul 24.

    PubMed 28737263

  • Chida K, Kanazawa H, Kinoshita H, Roy AM, Hakamada K, Takabe K. The role of lidocaine in cancer progression and patient survival. Pharmacol Ther. 2024 Jul;259:108654. doi: 10.1016/j.pharmthera.2024.108654. Epub 2024 May 1.

    PubMed 38701900

  • Manoleras AV, Sloan EK, Chang A. The sympathetic nervous system shapes the tumor microenvironment to impair chemotherapy response. Front Oncol. 2024 Sep 24;14:1460493. doi: 10.3389/fonc.2024.1460493. eCollection 2024.

    PubMed 39381049

  • Ramirez MF, Tran P, Cata JP. The effect of clinically therapeutic plasma concentrations of lidocaine on natural killer cell cytotoxicity. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):43-8. doi: 10.1097/AAP.0000000000000191.

    PubMed 25469757

  • Zhang H, Wang J, Li F. Modulation of natural killer cell exhaustion in the lungs: the key components from lung microenvironment and lung tumor microenvironment. Front Immunol. 2023 Nov 6;14:1286986. doi: 10.3389/fimmu.2023.1286986. eCollection 2023.

    PubMed 38022613

  • Piegeler T, Votta-Velis EG, Liu G, Place AT, Schwartz DE, Beck-Schimmer B, Minshall RD, Borgeat A. Antimetastatic potential of amide-linked local anesthetics: inhibition of lung adenocarcinoma cell migration and inflammatory Src signaling independent of sodium channel blockade. Anesthesiology. 2012 Sep;117(3):548-59. doi: 10.1097/ALN.0b013e3182661977.

    PubMed 22846676

  • Sullivan R, Alatise OI, Anderson BO, Audisio R, Autier P, Aggarwal A, Balch C, Brennan MF, Dare A, D'Cruz A, Eggermont AM, Fleming K, Gueye SM, Hagander L, Herrera CA, Holmer H, Ilbawi AM, Jarnheimer A, Ji JF, Kingham TP, Liberman J, Leather AJ, Meara JG, Mukhopadhyay S, Murthy SS, Omar S, Parham GP, Pramesh CS, Riviello R, Rodin D, Santini L, Shrikhande SV, Shrime M, Thomas R, Tsunoda AT, van de Velde C, Veronesi U, Vijaykumar DK, Watters D, Wang S, Wu YL, Zeiton M, Purushotham A. Global cancer surgery: delivering safe, affordable, and timely cancer surgery. Lancet Oncol. 2015 Sep;16(11):1193-224. doi: 10.1016/S1470-2045(15)00223-5.

    PubMed 26427363

  • Foo I, Macfarlane AJR, Srivastava D, Bhaskar A, Barker H, Knaggs R, Eipe N, Smith AF. The use of intravenous lidocaine for postoperative pain and recovery: international consensus statement on efficacy and safety. Anaesthesia. 2021 Feb;76(2):238-250. doi: 10.1111/anae.15270. Epub 2020 Nov 3.

    PubMed 33141959

  • Paterson H, Vadiveloo T, Innes K, Balfour A, Atter M, Stoddart A, Cotton S, Arnott R, Aucott L, Batham Z, Foo I, MacLennan G, Nimmo S, Speake D, Norrie J. Intravenous Lidocaine for Gut Function Recovery in Colonic Surgery: A Randomized Clinical Trial. JAMA. 2025 Jan 7;333(1):39-48. doi: 10.1001/jama.2024.23898.

    PubMed 39602290

Questions about this trial

What is this clinical trial studying?

A study testing Lidocaine (drug) in people with Non-Small Cell Lung Cancer and Recurrence, run by First Affiliated Hospital of Ningbo University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Changshun Huang, MD (+8613957882779, fyyhuangchangshun@nbu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-Free Survival (DFS) (time frame: Up to 36 months after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07347977, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in