Clinical trial NCT06243679: The Efficacy and Safety of Adjuvant Immunotherapy After Pathological Complete Response Following Neoadjuvant Chemoimmunotherapy in Patients with Resectable NSCLC
Official title: The Efficacy and Safety of Adjuvant Immunotherapy After Pathological Complete Response Following Neoadjuvant Chemoimmunotherapy in Patients with Resectable NSCLC: a Prospective Real-World Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Resectable/Potentially Resectable NSCLC
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with resectable non-small cell lung cancer (NSCLC) who have received immune checkpoint inhibitor neoadjuvant therapy and achieved pathological complete response (pCR).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: DFS (Disease-Free Survival)
timeFrame: Approximately 3 years
Secondary outcomes:
measure: 3-year DFS (disease-free survival) rate
timeFrame: Approximately 3 years
measure: OS (Overall Survival)
timeFrame: Approximately 3 years
measure: Recurrence and Metastasis Pattern
timeFrame: Approximately 3 years
measure: AE (Adverse Event)
timeFrame: Approximately 3 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital, Central South University Affiliated
state: Hunan
Study officials:
References: