The Efficacy and Safety of Adjuvant Immunotherapy After Pathological Complete Response Following Neoadjuvant Chemoimmunotherapy in Patients with Resectable NSCLC

Central South University

Status: Active, not recruiting

Conditions: Resectable/Potentially Resectable NSCLC

Treatments: Drug: Immunotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06243679

RWNEOADJ-01

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Adjuvant immunotherapy

Treatment:

Drug: Immunotherapy

Observational