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A phase II clinical trial of chemotherapy combined with Tislelizumab neoadjuvant therapy for resectable stage IIIA lung squamous cell carcinoma and exploration of related biomarkers

A phase II clinical trial of chemotherapy combined with Tislelizumab neoadjuvant therapy for resectable stage IIIA lung squamous cell carcinoma and exploration of related biomarkers

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058785
Enrollment
Unknown
Registered
2022-04-17
Start date
2022-04-17
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Non-small cell lung cancer

Interventions

Sponsors

Cancer Hospital Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Cytological or histological diagnosis of non-small cell lung cancer; 2. Resectable IIIA non-small cell lung cancer (IASLC/UICC staging eighth edition); 3. No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment; 4. ECOG score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery; 5. At least one measurable lesion (RECIST v1.1); 6. Age >= 18 years old and <= 75 years old; 7. Sign the written informed consent, and be able to abide by the visits and related procedures stipulated in the program.

Exclusion criteria

Exclusion criteria: 1. Patients with positive driver genes; 2. Immunosuppressive drugs have been used within 3 weeks before the first dose of treatment (excluding prednisone or other glucocorticoids with no more than 10 mg/day of equivalent dose); 3. Known or suspected active autoimmune disease; 4. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 5. Allergic to any component of monoclonal antibody; 6. Currently suffering from interstitial lung disease; 7. Suffering from other uncontrolled serious diseases; 8. Other acute or chronic diseases that may interfere with the test results of the research.

Design outcomes

Primary

MeasureTime frame
Major pathological response;

Secondary

MeasureTime frame
pCR (pathological complete response);ORR (objective reponse rate);DFS (disease free survival);OS (overall survival);

Countries

China

Contacts

Public ContactMao Yousheng

Cancer Hospital Chinese Academy of Medical Sciences

maoysherx@qq.com+86 13651386702

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026