Neoadjuvant Immune Checkpoint Inhibitor Combined With Chemotherapy in Non-small Cell Lung Cancer

NCT ID: NCT04945200

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-12-31

Brief Summary

The primary object of this study is to determine tumor major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer who subjected to neoadjuvant immune checkpoint inhibitor combined with chemotherapy and molecular biomarkers related to the clinical response.

Conditions

Non-small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1.Able to understand the nature of this trial and provide written informed consent.

2.18 years ≤ age ≤ 80 years

3.Histologically documented non-small cell lung cancer

4.NSCLC with resection option for potential cure.This may include clinical stage IB, II and IIIA.

5.Subjected to neoadjuvant immune checkpoint inhibitor combined with chemotherapy according to disease evaluation.

6.Measurable disease by RECIST v1.1

7.Tumor tissue sample and/or alveolar lavage fluid must be available for biomarker evaluation before operation.

Exclusion Criteria

1. Subjects are excluded if they are enrolled in any other interventional studies.

2. Administration of chemotherapy, device therapy or any other cancer therapy in 4 weeks before the study drug administration.

3. Subjects are excluded if they have an active, known or suspected autoimmune disease requiring systemic treatment (e.g.corticosteroids or other immunosuppressive medications) in 2 years before the study drug administration. substitution therapy ( e.g. thyroxine, insulin) are permitted.

4. Subjects with active concurrent malignancies are excluded i.e. cancers other than NSCLC.

5. History of allergy to study drug components

6. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results.

7. Any other conditions that, in the Investigator's opinion, unfit to attend this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Pingli Wang, M.D

Role: CONTACT

pingliwang@zju.edu.cn

+86 135 1680 8409

Facility Contacts

Pingli Wang, M.D

Role: primary

pingliwang@zju.edu.cn

+86 135 1680 8409

Other Identifiers

2020-1003

Identifier Type: -

Identifier Source: org_study_id