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

NCT06243679 | Active Not Recruiting

• 1 other identifier: RWNEOADJ-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Resectable/Potentially Resectable NSCLC

Outcome Measures

Primary Outcomes (1)

• DFS (Disease-Free Survival)

  Evaluated by investigator based on RECIST1.1

  Approximately 3 years

Secondary Outcomes (4)

• 3-year DFS (disease-free survival) rate

  Approximately 3 years

• OS (Overall Survival)

  Approximately 3 years

• Recurrence and Metastasis Pattern

  Approximately 3 years

• AE (Adverse Event)

  Approximately 3 years

Study Arms (2)

Adjuvant immunotherapy

Drug: Immunotherapy

Observational

Interventions

Immunotherapy DRUG

Monotherapy with PD-1 inhibitors, up to 1 year.

Adjuvant immunotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• years ≤ age ≤ 80 years;
• Histologically or cytologically confirmed NSCLC;
• Resectable stage IB, II, IIIA, or IIIB (N2) NSCLC according to the staging criteria of the American Joint Committee on Cancer (8th edition);
• Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 at baseline;
• With measurable or evaluable diseases according to the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) at baseline;
• Achieving pathological complete response (pCR) after three cycles of neoadjuvant chemoimmunotherapy, which was assessed by independent pathological examination of surgical specimens;
• With or without adjuvant immunotherapy postoperatively;
• Signed and dated written informed consent provided by the patient prior to admission to the study.

You may not qualify if:

• EGFR or ALK aberrations positive;
• With primary/secondary immunodeficiency diseases or symptomatic interstitial lung diseases;
• 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;
• With other active malignant tumors currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drugs;
• Receipt of other investigational drugs during the observation period;
• Unable to follow the procedures required in the protocol due to any medical, mental or psychological conditions.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital, Central South University Affiliated

Changsha, Hunan, 410008, China

Location

MeSH Terms

Interventions

Immunotherapy

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: July 1, 2020
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 6, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)