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

NCT07286942 | Not Yet Recruiting Phase 2

• 1 other identifier: LUNG-Nanjing 01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

NSCLC; NSCLC (Non-small Cell Lung Cancer)

Keywords

NSCLC; SBRT; neoadjuvant

Outcome Measures

Primary Outcomes (1)

• pCR

  up to surgery

Secondary Outcomes (3)

• MPR

  up to surgery

• DFS

  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)

  All participants were followed for safety until 90 days after the last dose of study treatment.

Study Arms (1)

neoadjuvant SBRT in combination with apalolimab and toripalimab (QL1706) plus

EXPERIMENTAL

Drug: apalolimab and toripalimab (QL1706)

Interventions

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%).

neoadjuvant SBRT in combination with apalolimab and toripalimab (QL1706) plus

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• \. 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.
• \. Superior sulcus (Pancoast) NSCLC, large-cell neuroendocrine carcinoma (LCNEC), or sarcomatoid carcinoma.
• \. Known EGFR-sensitive mutations or ALK rearrangements (non-squamous participants must have confirmed EGFR and ALK mutation status).
• \. Prior systemic anticancer therapy for early-stage NSCLC, including investigational agents.
• \. 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).
• \. Male or female participants of reproductive potential who are unwilling to use effective contraception during the study; pregnant or breastfeeding women.
• \. 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.

Sponsors & Collaborators

• Jiangsu Cancer Institute & Hospital: lead

Study Sites (1)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Zhi Zhang

CONTACT

+86 13951766976; zz5223404@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: December 18, 2025
• Primary Completion (Estimated): December 18, 2027
• Study Completion (Estimated): December 18, 2029
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

CN (1)