The Real World Study of Neoadjuvant Immunotherapy in Early Stage NSCLC in China

NCT ID: NCT04286841

Last Updated: 2020-02-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2029-12-31

Brief Summary

Several published clinical trials have shown the superiority of immunotherapy in neoadjuvant setting. Here we conducted this real world study to see whether neoadjuvant immunotherapy would bring MPR and survival benefits in NSCLC, for example, single agent immunotherapy or immunotherapy combination with chemotherapy. Furthermore biomarker analysis would be also performed to achieve personalized neoadjuvant immunotherapy.

Conditions

Immunotherapy; Lung Cancer

Study Design

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

Study Groups

Neoadjuvant immunotherapy

Immunotherapy

Intervention Type: DRUG

Patients in this group should be histologically confirmed potentially resectable NSCLC with stage II-IIIA. Furthermore patients would receive either single agent immunotherapy or immunotherapy combined with chemotherapy.

Interventions

Immunotherapy

Patients in this group should be histologically confirmed potentially resectable NSCLC with stage II-IIIA. Furthermore patients would receive either single agent immunotherapy or immunotherapy combined with chemotherapy.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Written informed consent provided
• Males or females aged ≥18 years
• Able to comply with the required protocol and follow-up procedures、
• Pathologically diagnosed of potentially resectable non-small cell lung cancer with stage II-IIIA (TNM 8th edition)
• Measurable disease must be characterized according to RECIST 1.1 criteria
• ECOG performance status 0-1
• Regardless of PD-L1 expression
• EGFR mutation (-) and ALK translocation (-)
• Pulmonary function could be well tolerated by lobectomy or pneumonectomy

Exclusion Criteria

• EGFR mutation (+) or ALK translocation (+)
• Active Central nervous system (CNS) metastases
• Patients with active, known or suspected autoimmune disease.
• Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included
• Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment
• Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
• Patients with a history of interstitial lung disease cannot be included if they have symptomatic ILD (Grade 3-4) and/or poor lung function. Patients with other active malignancy requiring concurrent intervention and/ or concurrent treatment with other investigational drugs or anti-cancer therapy
• Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/ dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
• Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information
• Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways Patients with positive test for hepatitis B virus surface antigen (HBVsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating active hepatitis
• Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) Patients with history of allergy to study drug components excipients
• Women who are pregnant or in the period of breastfeeding
• Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study
• In case of doubt please contact trial team.

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

Sponsors

Guangdong Association of Clinical Trials

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Si-Yang Liu

Role: CONTACT

momogogogo@126.com

13242305346 ext. 13242305346

Facility Contacts

Wen-Zhao Zhong, MD

Role: primary

Yi-Long Wu, MD

Role: backup

syylwu@live.cn

+86 20 83827812 ext. 51221

Other Identifiers

RW1804

Identifier Type: -

Identifier Source: org_study_id