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

NCT ID: NCT06243679

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2027-12-01

Brief Summary

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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

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Conditions

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Resectable/Potentially Resectable NSCLC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adjuvant immunotherapy

Immunotherapy

Intervention Type DRUG

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

Observational

No interventions assigned to this group

Interventions

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Immunotherapy

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xiangya Hospital, Central South University Affiliated

Changsha, Hunan, China

Site Status

Countries

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China

Other Identifiers

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RWNEOADJ-01

Identifier Type: -

Identifier Source: org_study_id