NCT07286942

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Jiangsu Cancer Institute & Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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)

Interventions

Type	Name	Description
DRUG	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%).

Timeline

• Start date: 2025-12-18
• Primary completion: 2027-12-18
• Completion: 2029-12-18
• First posted: 2025-12-16
• Last updated: 2025-12-16

Locations

1 site across 1 country: China