Stage IIA-IIIB NSCLCPhase 3NCT07617389
Selective Mediastinal Lymph Node Sampling Versus Systematic medIastinal Lymph Node Dissection After Neoadjuvant Chemoimmunotherapy for Non-small Cell Lung Cancer (SCIENCE Study)
A Phase 3 study testing selective mediastinal lymph node sampling and systematic mediastinal lymph node dissection in people with Stage IIA-IIIB NSCLC and Selective Mediastinal Lymph Node Sampling, run by Wen-zhao ZHONG at 1 site in China.
Trial summary
The SCIENCE trial is a multicenter, open-label, randomized, parallel, noninferiority investigator-initiated trial (IIT). This study aims to evaluate the prognostic differences between selective mediastinal lymph node sampling and systematic mediastinal lymph node dissection in patients with node-negative stage IIA to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stage IIA-IIIB NSCLC, Selective Mediastinal Lymph Node Sampling, Systematic medIastinal Lymph Node Dissection
- What is being tested?
- selective mediastinal lymph node sampling and systematic mediastinal lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to 1 Jun 2030
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation with a signed written informed consent form.
- Aged ≥ 18 and < 75 years, of either gender.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Anticipated life expectancy of ≥ 12 months.
- Histologically or pathologically confirmed peripheral non-small cell lung cancer (NSCLC), with clinical tumor, node, metastasis(TNM) stage IIA-IIIB, which according to the International Association for the Study of Lung Cancer(IASLC) 9th edition, and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
- Absence of satellite nodules involving different lung lobes.
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- No history of prior ipsilateral thoracotomy.
- Completion of neoadjuvant therapy prior to enrollment, consisting of a PD-1 inhibitor combined with platinum-based doublet chemotherapy.
- Adequate organ function.
- Cardiopulmonary function assessed by the investigator as meeting surgical standards, specifically: forced expiratory volume in one second (FEV1) > 1.0 L or diffusing capacity of the lung for carbon monoxide (DLCO) > 40% of the predicted value; and no other cardiopulmonary impairments that, in the investigator's judgment, would preclude surgery.
- Evaluation by a multidisciplinary team (MDT) or an evaluation committee* confirming that R0 resection can be achieved via anatomical lobectomy.
- Evaluation Committee: Composed of multidisciplinary experts with at least 10 years of clinical experience. Each participant's eligibility is discussed and evaluated by at least two experts to reach a consensus; in the event of a disagreement, a third expert will be invited for assessment.
Who cannot join
- Anticipated inability to tolerate an anatomical lobectomy;
- Anticipated requirement for sleeve resection, pneumonectomy, or pulmonary autotransplantation to remove the affected lobe;
- Prior thoracic radiotherapy before the initiation of surgical treatment;
- History of allogeneic tissue or solid organ transplantation;
- Diagnosis of an autoimmune disease within 3 months prior to surgery, or currently receiving long-term systemic corticosteroid therapy (at a dose >10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy;
- History of or current non-infectious interstitial lung disease requiring corticosteroid therapy;
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- Presence of viral infectious diseases during the screening period:
- Seropositivity for human immunodeficiency virus (HIV);
- Active hepatitis B: positive for hepatitis B surface antigen (HBsAg) with an HBV-DNA viral load >500 IU/mL or >2000 copies/mL;
- Active hepatitis C: positive for hepatitis C virus (HCV) antibody with an HCV-RNA viral load above the upper limit of normal (ULN);
- Poorly controlled hypertension despite medical therapy, defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg (adjustment of antihypertensive medications is permitted prior to study initiation, provided that the average of the last three consecutive blood pressure readings taken prior to enrollment is ≤150/90 mmHg, with at least a 2-minute interval between each measurement);
- Active infection requiring intravenous anti-infective therapy at the time of screening;
- History of another malignancy within 3 years prior to providing informed consent, excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix or breast, superficial bladder cancer, and localized prostate cancer. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, PSA <10 ng/mL) are eligible to enroll if they have received radical treatment or are under active surveillance with stable disease, regardless of prior treatment status;
- Any condition that, in the investigator's judgment, might interfere with the interpretation of study results, compromise the participant's ability to complete the study, or render study participation contrary to the participant's best interests;
- Pregnant, lactating, or planning to become pregnant; or having a positive serum pregnancy test within 7 days prior to the first study treatment;
- Poor compliance, or unwilling or unable to adhere to the protocol-specified procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Wen-Zhao Zhong, MD, 86-15920473691, 13609777314@163.com
Wen-Zhao Zhong, MD
About this study
Official title: Selective Mediastinal Lymph Node Sampling Versus Systematic medIastinal Lymph Node Dissection After Neoadjuvant Chemotherapy Combined With Immunotherapy for the Treatment of Clinical Stage IIA-IIIB (N2) Non-small Cell Lung Cancer
The SCIENCE trial is a multicenter, open-label, randomized, parallel, noninferiority investigator-initiated trial (IIT). This study aims to evaluate the prognostic differences between selective mediastinal lymph node sampling and systematic mediastinal lymph node dissection in patients with node-negative stage IIA to IIIB (N2) non-small-cell lung cancer (NSCLC) undergoing anatomical lobectomy following neoadjuvant chemoimmunotherapy.
- Conditions
- Stage IIA-IIIB NSCLC, Selective Mediastinal Lymph Node Sampling, Systematic medIastinal Lymph Node Dissection
- Being tested
- selective mediastinal lymph node sampling, systematic mediastinal lymph node dissection
- Keywords
- NSCLC, stage IIA-IIIB NSCLC, neoadjuvant, chemoimmunotherapy, selective mediastinal lymph node sampling, systematic medIastinal lymph node dissection, toripalimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selective mediastinal lymph node samplingProcedure or surgery
Patients randomized to the investigational group will undergo an anatomical lobectomy. Subsequently, no further lymph node resection or dissection will be performed in regional stations confirmed negative for metastasis by preoperative or intraoperative pathological evaluation (including negative preoperative endobronchial ultrasound [EBUS]-guided biopsies and negative intraoperative frozen sections). Postoperatively, patients will receive 1 cycle of platinum-based doublet chemotherapy combined with toripalimab immunotherapy, followed by 13 cycles of toripalimab immunotherapy.
systematic mediastinal lymph node dissectionProcedure or surgery
Patients randomized to the control group will undergo a systematic mediastinal lymph node dissection following the completion of an anatomical lobectomy. A radical dissection and clearance of the mediastinal lymph nodes will be performed. For right-sided procedures, this encompasses the right upper paratracheal, right lower paratracheal, and subcarinal regions; for left-sided procedures, this encompasses the para-aortic, aortopulmonary window, left lower paratracheal, and subcarinal regions. Postoperatively, patients will receive 1 cycle of platinum-based doublet chemotherapy combined with toripalimab immunotherapy, followed by 13 cycles of toripalimab immunotherapy.
| Study group | Role | What they receive |
|---|---|---|
| selective mediastinal lymph node sampling group | Experimental | Not described Receives: Procedure: selective mediastinal lymph node sampling |
| systematic medIastinal lymph node dissection group | Active comparator | Not described Receives: Procedure: systematic mediastinal lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year event-free survival (EFS) rate
Measured: Up to 2 years
Secondary outcomes (8)
2-year disease-free survival (DFS) rate
Measured: Up to 2 years
2-year overall survival (OS) rate
Measured: Up to 2 years
Dynamic changes in absolute and relative peripheral blood lymphocyte counts
Measured: Up to 2 years
Length of hospital stay
Measured: Up to 30 days post-operation
time of operation
Measured: Intraoperative
Intraoperative blood loss
Measured: Intraoperative
postoperative recurrence rate (including the incidence of local recurrence and distant metastasis).
Measured: Up to 2 years
Quality of life (QoL) scores at 6, 12, and 36 months postoperatively (assessed via the EORTC QLQ-C30).
Scale Title: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
Minimum and Maximum Values: 0 to 5. Score Interpretation: The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients. The EORTC QLQ-C30 consists of global health status, functional scales, and symptom scales. For the global health status and functional scales, higher scores represent a better quality of life/higher level of functioning. For the symptom scales, higher scores represent a higher level of symptomatology/worse outcome.
Measured: 6, 12, and 24 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start20 May 2026 (estimated)
- Primary completion15 May 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIA-IIIB NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wen-zhao ZHONG
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Responsible party
- Sponsor-investigator, Wen-zhao ZHONG, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617389
- Sponsor's protocol ID
- KY2026-391-02
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Mediastinal Lymph Node Sampling Versus Systematic medIastinal Lymph Node Dissection After Neoadjuvant Chemotherapy Combined With Immunotherapy for the Treatment of Clinical Stage IIA-IIIB (N2) Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07617389
- Acronym / sponsor ID
- KY2026-391-02
- Conditions
- Stage IIA-IIIB NSCLC, Selective Mediastinal Lymph Node Sampling, Systematic medIastinal Lymph Node Dissection
- Keywords
- NSCLC, stage IIA-IIIB NSCLC, neoadjuvant, chemoimmunotherapy, selective mediastinal lymph node sampling, systematic medIastinal lymph node dissection, toripalimab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Wen-zhao ZHONGUniversity, hospital or other
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 15 May 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The SCIENCE trial is a multicenter, open-label, randomized, parallel, noninferiority investigator-initiated trial (IIT). This study aims to evaluate the prognostic differences between selective mediastinal lymph node sampling and systematic mediastinal lymph node dissection in patients with node-negative stage IIA to IIIB (N2) non-small-cell lung cancer (NSCLC) undergoing anatomical lobectomy following neoadjuvant chemoimmunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| selective mediastinal lymph node sampling group | Experimental | Procedure: selective mediastinal lymph node sampling |
| systematic medIastinal lymph node dissection group | Active comparator | Procedure: systematic mediastinal lymph node dissection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntary participation with a signed written informed consent form.
- Aged ≥ 18 and < 75 years, of either gender.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Anticipated life expectancy of ≥ 12 months.
- Histologically or pathologically confirmed peripheral non-small cell lung cancer (NSCLC), with clinical tumor, node, metastasis(TNM) stage IIA-IIIB, which according to the International Association for the Study of Lung Cancer(IASLC) 9th edition, and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
Key exclusion criteria (16 listed)
- Anticipated inability to tolerate an anatomical lobectomy;
- Anticipated requirement for sleeve resection, pneumonectomy, or pulmonary autotransplantation to remove the affected lobe;
- Prior thoracic radiotherapy before the initiation of surgical treatment;
- History of allogeneic tissue or solid organ transplantation;
- Diagnosis of an autoimmune disease within 3 months prior to surgery, or currently receiving long-term systemic corticosteroid therapy (at a dose >10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selective mediastinal lymph node samplingPatients randomized to the investigational group will undergo an anatomical lobectomy. Subsequently, no further lymph node resection or dissection will be performed in regional stations confirmed negative for metastasis by preoperative or intraoperative pathological evaluation (including negative preoperative endobronchial ultrasound [EBUS]-guided biopsies and negative intraoperative frozen sections). Postoperatively, patients will receive 1 cycle of platinum-based doublet chemotherapy combined with toripalimab immunotherapy, followed by 13 cycles of toripalimab immunotherapy. | Procedure or surgery | selective mediastinal lymph node sampling group |
| systematic mediastinal lymph node dissectionPatients randomized to the control group will undergo a systematic mediastinal lymph node dissection following the completion of an anatomical lobectomy. A radical dissection and clearance of the mediastinal lymph nodes will be performed. For right-sided procedures, this encompasses the right upper paratracheal, right lower paratracheal, and subcarinal regions; for left-sided procedures, this encompasses the para-aortic, aortopulmonary window, left lower paratracheal, and subcarinal regions. Postoperatively, patients will receive 1 cycle of platinum-based doublet chemotherapy combined with toripalimab immunotherapy, followed by 13 cycles of toripalimab immunotherapy. | Procedure or surgery | systematic medIastinal lymph node dissection group |
Primary outcome
2-year event-free survival (EFS) rate
Time frame: Up to 2 years
8 secondary outcomes
2-year disease-free survival (DFS) rate
Time frame: Up to 2 years
2-year overall survival (OS) rate
Time frame: Up to 2 years
Dynamic changes in absolute and relative peripheral blood lymphocyte counts
Time frame: Up to 2 years
Length of hospital stay
Time frame: Up to 30 days post-operation
time of operation
Time frame: Intraoperative
Intraoperative blood loss
Time frame: Intraoperative
postoperative recurrence rate (including the incidence of local recurrence and distant metastasis).
Time frame: Up to 2 years
Quality of life (QoL) scores at 6, 12, and 36 months postoperatively (assessed via the EORTC QLQ-C30).
Time frame: 6, 12, and 24 months post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing selective mediastinal lymph node sampling and systematic mediastinal lymph node dissection in people with Stage IIA-IIIB NSCLC and Selective Mediastinal Lymph Node Sampling, run by Wen-zhao ZHONG 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 12 inclusion and 16 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 1 Jun 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Wen-Zhao Zhong, MD (86-13609777314, 13609777314@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year event-free survival (EFS) rate (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2026.