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A prospective, single arm, phase II clinical study on the combination of QL1706 and chemotherapy as neoadjuvant therapy for stage II-IIIB squamous non-small cell lung cancer

A prospective, single arm, phase II clinical study on the combination of QL1706 and chemotherapy as neoadjuvant therapy for stage II-IIIB squamous non-small cell lung cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104283
Enrollment
Unknown
Registered
2025-06-13
Start date
2025-10-01
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung squamous cell carcinoma

Interventions

Neoadjuvant therapy group:Research drug+chemotherapy neoadjuvant therapy

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age: 18-75 years old; 2.ECOG behavior status score 0-1; 3.Diagnosed with squamous non-small cell lung cancer through cytology or histopathology; 4.All suspicious mediastinal lymph nodes, including those with pathological enlargement or increased FDG metabolism on PET/CT, require further sampling for pathological confirmation (if possible through EBUS or mediastinoscopy); 5.According to AJCC 9th edition, the clinical stage is II-IIIB, which has been evaluated as operable or potentially resectable; 6.According to RECIST 1.1 standard, it has measurable lesions; 7.The level of organ function must meet the following requirements: a. Bone marrow: absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelets >= 100 × 10^9/L, hemoglobin >= 9 g/dl; b. Good coagulation function: defined as International Normalized Ratio (INR) or Prothrombin Time (PT) = 60 ml/min; 8.According to the assessment of the surgeon, the patient's lung function can tolerate the planned lobectomy surgery; 9.Women of childbearing age must undergo a pregnancy test with a negative result within 7 days before starting treatment, and take contraceptive measures during and within 3 months after treatment; Male of childbearing age: Take contraceptive measures during and within 3 months after surgical sterilization or treatment; 10.Understand and voluntarily sign a written informed consent form;

Exclusion criteria

Exclusion criteria: 1.There are locally advanced, unresectable, or metastatic diseases present; 2.Previously received any systemic anti-tumor therapy, including chemotherapy, radiotherapy, immunotherapy, or targeted therapy; 3.Patients with active, known or suspected autoimmune diseases or immunodeficiency; 4.Previous interstitial lung disease, drug-induced interstitial pneumonia, or any clinically proven active pneumonia/interstitial lung disease; 5.History of active pulmonary tuberculosis; 6.According to the researchers' assessment, there are any unstable systemic diseases present; 7.Uncontrolled active hepatitis B infection; 8.The patient previously suffered from other malignant tumors (except for fully treated basal cell or squamous cell skin cancer and the following in situ cancers: bladder cancer, gastric cancer, intestinal cancer, endometrial cancer, cervical/dysplasia, melanoma or breast cancer); 9.Known to have human immunodeficiency virus (HIV) infection; 10.Known severe allergy to QL1706, investigational chemotherapy drugs, and/or any of their excipients;

Design outcomes

Primary

MeasureTime frame
Pathologic complete response rate;

Secondary

MeasureTime frame
Major pathological remission;R0 resection rate;Event-free survival;Clinical response rat;Overall survival;

Countries

China

Contacts

Public ContactJian Zeng

Zhejiang Cancer Hospital

68640770@qq.com+86 571 88128101

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026