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An observational, bidirectional cohort real-world study evaluating the efficacy and safety of perioperative immunotherapy in resectable stage II-III NSCLC patients

An observational, bidirectional cohort real-world study evaluating the efficacy and safety of perioperative immunotherapy in resectable stage II-III NSCLC patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097551
Enrollment
Unknown
Registered
2025-02-20
Start date
2025-02-21
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

NSCLC

Interventions

Treatment group:None

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18–75 years, regardless of gender. 2. Patients with stage II–III non-small cell lung cancer (NSCLC) confirmed by histological or cytological examination, based on the 8th edition of the AJCC (American Joint Committee on Cancer) staging system. 3. Patients who have previously undergone curative lung cancer surgery. 4. Patients who have previously received =2 cycles of neoadjuvant platinum-based doublet chemotherapy combined with PD-1/PD-L1 antibody treatment. 5. EGFR or ALK wild-type status or unknown mutation status before neoadjuvant treatment.

Exclusion criteria

Exclusion criteria: 1. Patients with clinical stage I, unresectable stage III, or stage IV non-small cell lung cancer (NSCLC). 2. Patients with a history of other malignancies, or those who have other malignancies during neoadjuvant treatment (except for malignancies that have been completely resected and have not recurred for 5 years postoperatively, such as cervical carcinoma in situ, basal cell carcinoma of the skin, and papillary thyroid carcinoma). 3. Patients who have previously received other systemic anti-tumor treatments. 4. Patients who have received neoadjuvant targeted therapy ± chemotherapy. 5. Patients who have not undergone surgical treatment. 6. Patients with incomplete key clinical and treatment information are excluded.

Design outcomes

Primary

MeasureTime frame
Objective response rate;Disease control rate;Radiological Downstaging Rate;R0 resection rate;Major Pathological Response Rate;Pathological Complete Response Rate;Pathological Downstaging Rate;Event-free survival;overall survival;

Countries

China

Contacts

Public ContactJun Chen

Tianjin Medical University General Hospital

huntercj2004@qq.com+86 158 2219 2921

Outcome results

None listed

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