Resectable/Potentially Resectable NSCLC
Conditions
Brief summary
This is a prospective, observational, multicenter real-world study aiming to investigate the efficacy and safety of NSCLC patients with or without adjuvant immunotherapy who have achieved pathologic complete remission after neoadjuvant immunotherapy.
Interventions
DRUGImmunotherapy
Monotherapy with PD-1 inhibitors, up to 1 year.
Sponsors
Xiangya Hospital of Central South University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 18 years ≤ age ≤ 80 years; 2. Histologically or cytologically confirmed NSCLC; 3. Resectable stage IB, II, IIIA, or IIIB (N2) NSCLC according to the staging criteria of the American Joint Committee on Cancer (8th edition); 4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 at baseline; 5. With measurable or evaluable diseases according to the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) at baseline; 6. Achieving pathological complete response (pCR) after three cycles of neoadjuvant chemoimmunotherapy, which was assessed by independent pathological examination of surgical specimens; 7. With or without adjuvant immunotherapy postoperatively; 8. Signed and dated written informed consent provided by the patient prior to admission to the study.
Exclusion criteria
1. EGFR or ALK aberrations positive; 2. With primary/secondary immunodeficiency diseases or symptomatic interstitial lung diseases; 3. With a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of study drug administration; 4. With other active malignant tumors currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drugs; 5. Receipt of other investigational drugs during the observation period; 6. Unable to follow the procedures required in the protocol due to any medical, mental or psychological conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DFS (Disease-Free Survival) | Approximately 3 years | Evaluated by investigator based on RECIST1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year DFS (disease-free survival) rate | Approximately 3 years | Evaluated by investigator based on RECIST1.1 |
| OS (Overall Survival) | Approximately 3 years | Evaluated by investigator based on RECIST1.1 |
| Recurrence and Metastasis Pattern | Approximately 3 years | — |
| AE (Adverse Event) | Approximately 3 years | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered an investigational product. Safety and tolerance evaluated by incidence, severity and outcomes of AEs (according to NCICTCAE 5.0) |
Countries
China
Outcome results
None listed