NSCLCPhase 2NCT07286942
Stereotactic Body Radiotherapy With Sequential Iparomlimab and Tuvonralimab (QL1706) + Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Non-small-cell Lung Cancer in China (LUNG-Nanjing01): a Single-arm, Single-centre, Phase 2 Trial
A Phase 2 study testing apalolimab and toripalimab (QL1706) in people with NSCLC and NSCLC (Non-small Cell Lung Cancer), run by Jiangsu Cancer Institute & Hospital at 1 site in China.
Trial summary
The primary objective of this study is to evaluate whether neoadjuvant SBRT as an immunomodulator in combination with apalolimab and toripalimab (QL1706) plus chemotherapy improves the pathological complete response (pCR) rate in patients with resectable stage IIA-IIIB LUAD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC, NSCLC (Non-small Cell Lung Cancer)
- What is being tested?
- apalolimab and toripalimab (QL1706)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2025to 18 Dec 2029
- Phase
- Phase 2
- 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
- Voluntarily participates in the study and provides written informed consent;
- Aged 18-75 years, with no restriction on sex;
- Histologically or cytologically confirmed diagnosis of non-small-cell lung cancer (NSCLC);
- Has not received prior systemic therapy and is willing to undergo neoadjuvant treatment for stage cⅡ-Ⅲ (N2a) disease, according to the 9th edition of the AJCC staging system (Appendix 1);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (see Appendix 2 for scoring criteria);
- Considered by the thoracic surgeon to have adequate pulmonary reserve to tolerate the planned lung resection;
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- Availability of tumor tissue prior to enrollment for pathological confirmation of EGFR/ALK wild-type status and PD-L1 expression assessment;
- No significant hematologic, cardiac, pulmonary, hepatic, renal, or immunologic dysfunction, with the following laboratory parameters meeting the specified criteria:
- Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count ≥80×10⁹/L; hemoglobin ≥9 g/dL;
- Liver function: total bilirubin ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5× ULN;
- Renal function: serum creatinine ≤1.5× ULN or creatinine clearance ≥60 mL/min; blood urea nitrogen ≤200 mg/L;
- Women of childbearing potential must have a negative serum pregnancy test within 3 days before the first dose of study treatment.
Who cannot join
- 1. Presence of locally advanced unresectable or metastatic disease. Unresectable disease is defined according to the 2019 Multidisciplinary Consensus on Stage III Non-Small-Cell Lung Cancer (NSCLC), including certain stage IIIA and IIIB cases and all stage IIIC cases. Typically, this includes N2 disease with a single mediastinal lymph node ≥3 cm in short axis or multiple fused lymph nodes (≥2 cm in short axis on CT), as well as T4 lesions invading the esophagus, heart, aorta, or pulmonary veins, and all N3 disease.
- 2. Superior sulcus (Pancoast) NSCLC, large-cell neuroendocrine carcinoma (LCNEC), or sarcomatoid carcinoma.
- 3. Known EGFR-sensitive mutations or ALK rearrangements (non-squamous participants must have confirmed EGFR and ALK mutation status).
- 4. Prior systemic anticancer therapy for early-stage NSCLC, including investigational agents.
- 5. Active infection, or unexplained fever >38.5 °C within 2 weeks prior to screening (participants with tumor-related fever, as judged by the investigator, may be enrolled).
- 6. Male or female participants of reproductive potential who are unwilling to use effective contraception during the study; pregnant or breastfeeding women.
- 7. Any condition that, in the opinion of the investigator, could interfere with study participation or completion, including severe comorbidities (including psychiatric disorders) requiring concurrent treatment, or family or social factors that may compromise participant safety or data integrity.
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
Jiangsu Cancer Hospital
Nanjing, Jiangsu
Zhang, +86 139 5176 6976, zz5223404@163.com
About this study
The primary objective of this study is to evaluate whether neoadjuvant SBRT as an immunomodulator in combination with apalolimab and toripalimab (QL1706) plus chemotherapy improves the pathological complete response (pCR) rate in patients with resectable stage IIA-IIIB LUAD. The secondary objectives include major pathological response (MPR), disease-free survival (DFS), R0 resection rate, the feasibility and safety. Moreover, the potential predictors for pathological response also will be explored.
Read the detailed description
This is a prospective, single-center, single-arm, phase II trial (LUNG-Nanjing01 study), patients will be recruited from Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu, China. Eligible participants are adults aged 18 or older, a biopsy-confirmed diagnosis of locally advanced NSCLC, clinical stage IIA to IIIB (according to the 9th edition of the American Joint Committee on Cancer staging system), determined by computed tomography and/or magnetic resonance imaging before treatments and deemed surgical resectable with curative intent. Every patient will be evaluated by a multidisciplinary team consisting of thoracic surgeons, medical oncologists, radiation oncologists, radiologists, and pathologists. Enrolled patients have no prior cancer treatments, with an Eastern Cooperative Oncology Group performance status of 0 or 1, regardless of smoking history and PD-L1/PD-1 expression.
- Conditions
- NSCLC, NSCLC (Non-small Cell Lung Cancer)
- Being tested
- apalolimab and toripalimab (QL1706)
- Keywords
- NSCLC, SBRT, neoadjuvant
- 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.
apalolimab and toripalimab (QL1706)Drug
QL1706 is a bispecific antibody developed using the MabPair™ biotechnology platform. It comprises two engineered monoclonal antibodies targeting PD-1 and CTLA-4, respectively, in a fixed ratio of approximately 2:1 (65:35 ± 10%).
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant SBRT in combination with apalolimab and toripalimab (QL1706) plus | Experimental | Not described Receives: Drug: apalolimab and toripalimab (QL1706) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
Measured: up to surgery
Secondary outcomes (3)
MPR
Measured: up to surgery
DFS
Measured: assessments were performed every 3 months during the first 3 years after surgery and every 6 months during years 3-5 of follow-up
Safety(AEs)
Measured: All participants were followed for safety until 90 days after the last dose of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start18 Dec 2025 (estimated)
- Primary completion18 Dec 2027 (estimated)
- Study completion18 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Zhi, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286942
- Sponsor's protocol ID
- LUNG-Nanjing 01
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiotherapy With Sequential Iparomlimab and Tuvonralimab (QL1706) + Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Non-small-cell Lung Cancer in China (LUNG-Nanjing01): a Single-arm, Single-centre, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT07286942
- Acronym / sponsor ID
- LUNG-Nanjing 01
- Conditions
- NSCLC, NSCLC (Non-small Cell Lung Cancer)
- Keywords
- NSCLC, SBRT, neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Study start
- 18 Dec 2025 (estimated)
- Primary completion
- 18 Dec 2027 (estimated)
- Study completion
- 18 Dec 2029 (estimated)
- First posted
- 16 Dec 2025 (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 primary objective of this study is to evaluate whether neoadjuvant SBRT as an immunomodulator in combination with apalolimab and toripalimab (QL1706) plus chemotherapy improves the pathological complete response (pCR) rate in patients with resectable stage IIA-IIIB LUAD. The secondary objectives include major pathological response (MPR), disease-free survival (DFS), R0 resection rate, the feasibility and safety. Moreover, the potential predictors for pathological response also will be explored.
Detailed description
This is a prospective, single-center, single-arm, phase II trial (LUNG-Nanjing01 study), patients will be recruited from Affiliated Cancer Hospital of Nanjing Medical University, Jiangsu, China. Eligible participants are adults aged 18 or older, a biopsy-confirmed diagnosis of locally advanced NSCLC, clinical stage IIA to IIIB (according to the 9th edition of the American Joint Committee on Cancer staging system), determined by computed tomography and/or magnetic resonance imaging before treatments and deemed surgical resectable with curative intent. Every patient will be evaluated by a multidisciplinary team consisting of thoracic surgeons, medical oncologists, radiation oncologists, radiologists, and pathologists. Enrolled patients have no prior cancer treatments, with an Eastern Cooperative Oncology Group performance status of 0 or 1, regardless of smoking history and PD-L1/PD-1 expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant SBRT in combination with apalolimab and toripalimab (QL1706) plus | Experimental | Drug: apalolimab and toripalimab (QL1706) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily participates in the study and provides written informed consent;
- Aged 18-75 years, with no restriction on sex;
- Histologically or cytologically confirmed diagnosis of non-small-cell lung cancer (NSCLC);
- Has not received prior systemic therapy and is willing to undergo neoadjuvant treatment for stage cⅡ-Ⅲ (N2a) disease, according to the 9th edition of the AJCC staging system (Appendix 1);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (see Appendix 2 for scoring criteria);
Key exclusion criteria (7 listed)
- 1. Presence of locally advanced unresectable or metastatic disease. Unresectable disease is defined according to the 2019 Multidisciplinary Consensus on Stage III Non-Small-Cell Lung Cancer (NSCLC), including certain stage IIIA and IIIB cases and all stage IIIC cases. Typically, this includes N2 disease with a single mediastinal lymph node ≥3 cm in short axis or multiple fused lymph nodes (≥2 cm in short axis on CT), as well as T4 lesions invading the esophagus, heart, aorta, or pulmonary veins, and all N3 disease.
- 2. Superior sulcus (Pancoast) NSCLC, large-cell neuroendocrine carcinoma (LCNEC), or sarcomatoid carcinoma.
- 3. Known EGFR-sensitive mutations or ALK rearrangements (non-squamous participants must have confirmed EGFR and ALK mutation status).
- 4. Prior systemic anticancer therapy for early-stage NSCLC, including investigational agents.
- 5. Active infection, or unexplained fever >38.5 °C within 2 weeks prior to screening (participants with tumor-related fever, as judged by the investigator, may be enrolled).
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 |
|---|---|---|
| apalolimab and toripalimab (QL1706)QL1706 is a bispecific antibody developed using the MabPair™ biotechnology platform. It comprises two engineered monoclonal antibodies targeting PD-1 and CTLA-4, respectively, in a fixed ratio of approximately 2:1 (65:35 ± 10%). | Drug | neoadjuvant SBRT in combination with apalolimab and toripalimab (QL1706) plus |
Primary outcome
pCR
Time frame: up to surgery
3 secondary outcomes
MPR
Time frame: up to surgery
DFS
Time frame: assessments were performed every 3 months during the first 3 years after surgery and every 6 months during years 3-5 of follow-up
Safety(AEs)
Time frame: All participants were followed for safety until 90 days after the last dose of study treatment.
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 16 Dec 2025.
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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 2 study testing apalolimab and toripalimab (QL1706) in people with NSCLC and NSCLC (Non-small Cell Lung Cancer), run by Jiangsu Cancer Institute & Hospital 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 7 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 Dec 2025. 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 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?
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 Zhi Zhang (+86 13951766976, zz5223404@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: up to surgery). 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 16 Dec 2025.