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Stage IIIA Non-small Cell Lung CancerPhase 2NCT04062708

CHIO3 Trial: CHemotherapy Combined With Immune Checkpoint Inhibitor for Operable Stage IIIA/B Non-Small Cell Lung Cancer

A Phase 2 study testing Durvalumab, Surgery and Radiotherapy in people with Stage IIIA Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, run by Alliance Foundation Trials, LLC. at 9 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a single arm, phase II trial of combined neoadjuvant platinum doublet chemotherapy plus durvalumab followed by surgery, postoperative radiation and adjuvant durvalumab for 13 cycles for patients with potentially resectable stage IIIA and IIIB (T1-3, N2) NSCLC (per the 8th International Association for the… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Durvalumab, Surgery and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
9 sitesUnited States
Study dates
10 Mar 2021to Jul 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who are at least 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
  • Life expectancy of at least 12 weeks.
  • Patients with potentially resectable IIIA/B (T1-3, N2) NSCLC (per the 8th International Association for the Study of Lung Cancer classification) who are candidates for surgery with intent of R0 resection. Invasive T3 disease (eg, phrenic nerve, pericardium, chest wall other than Pancoast superior sulcus) may be included if the surgeon and study team deem it to be resectable. T4 disease per AJCC 8th edition staging system is excluded given the lack of benefit of surgery in T4N2.
  • Patients must be evaluated by a thoracic surgeon within 4 weeks of registration.
  • Operability is defined as having adequate pulmonary, cardiac, renal, nutritional, musculoskeletal, neurologic, and cognitive capacity to undergo major pulmonary resection with acceptable morbidity and mortality.
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  • N2 nodes must be discrete (ie, not invading surrounding structures) and less than 3 cm in maximum diameter.
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
  • Pathologically proven N2 disease within 4 weeks of registration. PET/CT positivity in the ipsilateral mediastinal nodes will not be sufficient to establish N2 nodal status. Mediastinal lymph node sampling biopsy is required pre-operatively by at least one of the following:
  • Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA);
  • Mediastinoscopy;
  • Mediastinotomy (Chamberlain procedure);
  • Endoscopic ultrasound guided node aspiration (EUS);
  • Video-assisted thoracoscopy; OR
  • Fine needle aspiration by image guidance.
  • Endobronchial ultrasound (EBUS) or mediastinoscopy or other tissue sampling (at least 2 stations must be biopsied, with at least one station positive for N2 disease). If there are any mediastinal nodes suspicious by CT (>1.5 cm) or PET in N3 stations, they must be biopsied. If biopsy proven involvement in an N3 station, the patient is excluded.
  • Mediastinal nodal biopsy or aspiration can only be omitted in the special circumstance in which ALL of the following are true:
  • The tumor is left sided;
  • The only mediastinal nodal involvement is a node visible in the AP (level 5) region on CT scan;
  • Distinct primary tumor separate from the nodes; AND
  • Biopsy proven non-small cell histology from the primary tumor.
  • No prior history of thoracic radiation.
  • Organ and marrow function definitions (example below)
  • leukocytes ≥3,000/mcL
  • absolute neutrophil count ≥1,500/mcL
  • platelets ≥100,000/mcL
  • Hemoglobin >9.0 g/dL
  • total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
  • creatinine within normal institutional limits OR
  • creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
  • Patients are capable of giving informed consent and/or have an acceptable surrogate capable of giving consent on the subject's behalf.
  • Nonpregnant and non-nursing. The effect of durvalumab on the fetus is unknown.
  • Women of childbearing potential (WOCBP) must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 3 months after the last dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free of menses >1 year.
  • Evidence of postmenopausal status or negative urinary or serum pregnancy test for female premenopausal patients. Women will be considered postmenopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Women <50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Women ≥50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • Male patients must agree to use an adequate method of contraception starting with the first dose of study therapy through 12 weeks after the last dose of study therapy.

Who cannot join

  • Any prior treatment for NSCLC.
  • Prior thoracic radiation.
  • Patients with ≥Grade 2 peripheral neuropathy.
  • Any active or history of autoimmune disease (including any history of inflammatory bowel disease) or history of a syndrome that required systemic steroids or immunosuppressive medications, except for patients with vitiligo or resolved childhood asthma/atopy.
  • Patients requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses <10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Patients with previous malignancies (except nonmelanoma skin cancers, in situ bladder, gastric, breast, colon or cervical cancers/dysplasia) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.
Show all 19Show fewer
  • History of solid organ transplant.
  • N3 nodal disease.
  • Mixed small cell/NSCLC will be excluded.
  • Pregnant or breastfeeding.
  • History of allogenic organ transplantation.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], active diverticulitis with the exception of diverticulosis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
  • Patients with vitiligo or alopecia.
  • Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement.
  • Any chronic skin condition that does not require systemic therapy.
  • Patients without active disease in the last 5 years may be included but only after consultation with the study physician.
  • Patients with celiac disease controlled by diet alone.
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
  • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • NorthWestern University

    Chicago, Illinois, 60611

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • Baptist Cancer Center

    Memphis, Tennessee, 38120

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

Other trials in United States

About this study

This is a single arm, phase II trial of combined neoadjuvant platinum doublet chemotherapy plus durvalumab followed by surgery, postoperative radiation and adjuvant durvalumab for 13 cycles for patients with potentially resectable stage IIIA and IIIB (T1-3, N2) NSCLC (per the 8th International Association for the Study of Lung Cancer classification). The primary objective of this study is to increase N2 nodal clearance (N2NC) to 50% or greater for combined platinum doublet chemotherapy with durvalumab induction therapy from historical rate of 30% for platinum doublet chemotherapy alone in patients with potentially resectable stage IIIA/B (N2) NSCLC.

Read the detailed description

In the preoperative period, patients who have undergone adequate mediastinal evaluation and are considered operable will be treated with durvalumab 1125 mg IV every 3 weeks (Q3W) in combination with platinum doublet chemotherapy (cisplatin with pemetrexed or docetaxel, depending upon histology).

Patients will undergo postoperative radiation (54Gy) within 4-10 weeks after surgery (unless single station N2 at registration with resultant ypT0N0 after neoadjuvant therapy).

One to 6 weeks after completion of radiation, patients will receive adjuvant durvalumab 1500 mg IV every 4weeks (Q4W) for 1 year.

Patients who do not have surgery due to refusal, physician decision, or local and distant progression will have to discontinue study treatment.

All participants will have imaging assessment prior to surgery after Cycle 2 (Week 6) and after Cycle 4 (Weeks 13 15). Patients will undergo potentially curable surgery as per standard of care.

Patients will undergo imaging assessment every 12 weeks after surgery for 2 years, then every 6 months for 3 years.

Being tested
Durvalumab, Surgery, Radiotherapy
Keywords
Stage IIIA/IIIB (T1-3,N2) Non-Small Cell Lung Cancer (NSCLC)
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • DurvalumabDrug

    Also called Imfinzi

    Preoperative Treatment:

    • Non-squamous NSCLC: durvalumab 1125 mg, followed by pemetrexed 500 mg/m2 IV with cisplatin 75 mg/m2 IV, every 3 weeks, for 4 cycles
    • Squamous NSCLC: durvalumab 1125 mg, followed by docetaxel 75 mg/m2 IV with cisplatin 75 mg/m2 IV, every 3 weeks, for 4 cycles

    Adjuvant Therapy:

    • 1-6 weeks after completion of radiotherapy, durvalumab 1500 mg IV every 4 weeks will be administered for 13 cycles.

  • SurgeryProcedure or surgery

    Patients will be re-evaluated following preoperative treatment to assess if patient is still medically fit to withstand surgery. Eligible patients will then undergo lobectomy, bilobectomy, sleeve lobectomy or other extended resection, or a pneumonectomy will be performed at the discretion of the attending thoracic surgeon.

  • RadiotherapyRadiation

    4-10 weeks after surgery, patients will receive 54 Gy of radiotherapy with single daily fractions.

Study groups in NCT04062708
Study groupRoleWhat they receive
TreatmentExperimentalCombined neoadjuvant platinum doublet chemotherapy plus durvalumab followed by surgery, postoperative radiation and adjuvant durvalumab for 13 cycles.
Receives: Drug: Durvalumab; Procedure: Surgery; Radiation: Radiotherapy

What is being measured

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

  1. N2 Nodal Clearance (N2NC)

    The percent of patient to increase N2 nodal clearance (N2NC) to 50% or greater for combined platinum doublet chemotherapy with durvalumab induction from an historical rate of 30% for platinum doublet chemotherapy alone in patients with potentially resectable stage IIIA/B (N2) NSCLC.

    Measured: 3 years 11 months

Secondary outcomes (7)

  1. Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

    To evaluate the safety and tolerability of neoadjuvant platinum doublet chemotherapy and durvalumab followed by surgery followed by adjuvant radiation and durvalumab.

    Measured: 5 years

  2. Radiographic Response Rate

    To assess the radiographic response rate of neoadjuvant platinum doublet chemotherapy and durvalumab.

    Measured: 5 years

  3. Rate of Major Pathologic Response and Pathologic Complete Response

    To evaluate the rate of major pathologic response and pathologic complete response in the resected primary tumor and lymph nodes following neoadjuvant combination therapy as evaluated per criteria stated in the study protocol.

    Measured: 16 weeks

  4. Evaluate Event Free Survival (EFS)

    EFS evaluated from the time of registration to one of the following events, whichever comes first: a) radiographic disease progression, b) local progression as defined by lymph node progression precluding surgery, c) inability to resect the tumor, d) local or distant recurrence, e) death due to any cause.

    Measured: 5 years

  5. Overall Survival Rate

    To evaluate overall survival rate from the time of registration

    Measured: 5 years

  6. Rate of Complete Resection.

    To assess the rate of complete resection.

    Measured: 16 weeks

  7. Post-operative Complications

    To assess post-operative complications

    Measured: Within 30 days of surgery

Timeline

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

  1. First posted20 Aug 2019
  2. Study start10 Mar 2021
  3. Primary completion24 Feb 2025
  4. Study completionJul 2027 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04062708
Sponsor's protocol ID
AFT-46
Status last verified
Jul 2026
First submitted
8 Aug 2019
Last updated
23 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Goldstraw P, Chansky K, Crowley J, Rami-Porta R, Asamura H, Eberhardt WE, Nicholson AG, Groome P, Mitchell A, Bolejack V; International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee, Advisory Boards, and Participating Institutions; International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee Advisory Boards and Participating Institutions. The IASLC Lung Cancer Staging Project: Proposals for Revision of the TNM Stage Groupings in the Forthcoming (Eighth) Edition of the TNM Classification for Lung Cancer. J Thorac Oncol. 2016 Jan;11(1):39-51. doi: 10.1016/j.jtho.2015.09.009.

    PubMed 26762738

  • Albain KS, Swann RS, Rusch VW, Turrisi AT 3rd, Shepherd FA, Smith C, Chen Y, Livingston RB, Feins RH, Gandara DR, Fry WA, Darling G, Johnson DH, Green MR, Miller RC, Ley J, Sause WT, Cox JD. Radiotherapy plus chemotherapy with or without surgical resection for stage III non-small-cell lung cancer: a phase III randomised controlled trial. Lancet. 2009 Aug 1;374(9687):379-86. doi: 10.1016/S0140-6736(09)60737-6. Epub 2009 Jul 24.

    PubMed 19632716

  • Darling GE, Li F, Patsios D, Massey C, Wallis AG, Coate L, Keshavjee S, Pierre A, De Perrot M, Yasufuku K, Cypel M, Waddell T. Neoadjuvant chemoradiation and surgery improves survival outcomes compared with definitive chemoradiation in the treatment of stage IIIA N2 non-small-cell lung cancer. Eur J Cardiothorac Surg. 2015 Nov;48(5):684-90; discussion 690. doi: 10.1093/ejcts/ezu504. Epub 2015 Jan 6.

    PubMed 25567960

  • Pless M, Stupp R, Ris HB, Stahel RA, Weder W, Thierstein S, Gerard MA, Xyrafas A, Fruh M, Cathomas R, Zippelius A, Roth A, Bijelovic M, Ochsenbein A, Meier UR, Mamot C, Rauch D, Gautschi O, Betticher DC, Mirimanoff RO, Peters S; SAKK Lung Cancer Project Group. Induction chemoradiation in stage IIIA/N2 non-small-cell lung cancer: a phase 3 randomised trial. Lancet. 2015 Sep 12;386(9998):1049-56. doi: 10.1016/S0140-6736(15)60294-X. Epub 2015 Aug 11.

    PubMed 26275735

  • Higgins K, Chino JP, Marks LB, Ready N, D'Amico TA, Clough RW, Kelsey CR. Preoperative chemotherapy versus preoperative chemoradiotherapy for stage III (N2) non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1462-7. doi: 10.1016/j.ijrobp.2009.01.069. Epub 2009 May 19.

    PubMed 19467798

  • Edelman MJ, Hu C, Le QT, Donington JS, D'Souza WD, Dicker AP, Loo BW, Gore EM, Videtic GMM, Evans NR, Leach JW, Diehn M, Feigenberg SJ, Chen Y, Paulus R, Bradley JD. Randomized Phase II Study of Preoperative Chemoradiotherapy +/- Panitumumab Followed by Consolidation Chemotherapy in Potentially Operable Locally Advanced (Stage IIIa, N2+) Non-Small Cell Lung Cancer: NRG Oncology RTOG 0839. J Thorac Oncol. 2017 Sep;12(9):1413-1420. doi: 10.1016/j.jtho.2017.06.007. Epub 2017 Jun 16.

    PubMed 28629896

  • Gandhi L, Rodriguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Viqueira B, Novello S, Kurata T, Gray JE, Vida J, Wei Z, Yang J, Raftopoulos H, Pietanza MC, Garassino MC; KEYNOTE-189 Investigators. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer. N Engl J Med. 2018 May 31;378(22):2078-2092. doi: 10.1056/NEJMoa1801005. Epub 2018 Apr 16.

    PubMed 29658856

  • Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16.

    PubMed 29658848

  • Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR; KEYNOTE-024 Investigators. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016 Nov 10;375(19):1823-1833. doi: 10.1056/NEJMoa1606774. Epub 2016 Oct 8.

    PubMed 27718847

  • Postoperative radiotherapy in non-small-cell lung cancer: systematic review and meta-analysis of individual patient data from nine randomised controlled trials. PORT Meta-analysis Trialists Group. Lancet. 1998 Jul 25;352(9124):257-63.

    PubMed 9690404

  • Dautzenberg B, Arriagada R, Chammard AB, Jarema A, Mezzetti M, Mattson K, Lagrange JL, Le Pechoux C, Lebeau B, Chastang C. A controlled study of postoperative radiotherapy for patients with completely resected nonsmall cell lung carcinoma. Groupe d'Etude et de Traitement des Cancers Bronchiques. Cancer. 1999 Jul 15;86(2):265-73. doi: 10.1002/(sici)1097-0142(19990715)86:23.0.co;2-b.

    PubMed 10421262

  • Debevec M, Bitenc M, Vidmar S, Rott T, Orel J, Strojan P, Kovac V. Postoperative radiotherapy for radically resected N2 non-small-cell lung cancer (NSCLC): randomised clinical study 1988-1992. Lung Cancer. 1996 Feb;14(1):99-107. doi: 10.1016/0169-5002(95)00515-3.

    PubMed 8696724

  • Stephens RJ, Girling DJ, Bleehen NM, Moghissi K, Yosef HM, Machin D. The role of post-operative radiotherapy in non-small-cell lung cancer: a multicentre randomised trial in patients with pathologically staged T1-2, N1-2, M0 disease. Medical Research Council Lung Cancer Working Party. Br J Cancer. 1996 Aug;74(4):632-9. doi: 10.1038/bjc.1996.413.

    PubMed 8761382

  • Burdett S, Rydzewska L, Tierney J, Fisher D, Parmar MK, Arriagada R, Pignon JP, Le Pechoux C; PORT Meta-analysis Trialists Group. Postoperative radiotherapy for non-small cell lung cancer. Cochrane Database Syst Rev. 2016 Oct 11;10(10):CD002142. doi: 10.1002/14651858.CD002142.pub4.

    PubMed 27727451

  • Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.

    PubMed 28885881

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab, Surgery and Radiotherapy in people with Stage IIIA Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, run by Alliance Foundation Trials, LLC. at 9 sites in United States.

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 39 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

N2 Nodal Clearance (N2NC) (time frame: 3 years 11 months). 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 NCT04062708, which also lists 35 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 23 Sep 2026.

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