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

Active, not recruiting

• Conditions: Resectable/Potentially Resectable NSCLC
• Interventions: Drug: Immunotherapy

• Registration Number: NCT06243679
• Lead Sponsor: Xiangya Hospital of Central South University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-06
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2027-09-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adjuvant immunotherapy	Immunotherapy	-

Primary Outcome Measures

Name	Time	Method
DFS (Disease-Free Survival)	Approximately 3 years	Evaluated by investigator based on RECIST1.1

Secondary Outcome Measures

Name	Time	Method
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)
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

Trial Locations

Locations (1)

Xiangya Hospital, Central South University Affiliated; 🇨🇳 Changsha, Hunan, China