Evaluating neoadjuvant immunotherapy for early stage lung cancer in China
The Real World Study of Neoadjuvant Immunotherapy in Early Stage NSCLC in China
This study is testing if a new type of immunotherapy, alone or with chemotherapy, can help people with early-stage lung cancer in China feel better and live longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guangdong Association of Clinical Trials Academic / other |
| Drugs / interventions | prednisone, chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04286841 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of neoadjuvant immunotherapy in patients with early-stage non-small cell lung cancer (NSCLC) in China. It will analyze the impact of single-agent immunotherapy and immunotherapy combined with chemotherapy on major pathological response (MPR) and overall survival. Additionally, biomarker analysis will be conducted to tailor immunotherapy approaches for individual patients. The study will include patients with stage II-IIIA NSCLC who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pathologically diagnosed, potentially resectable stage II-IIIA NSCLC and an ECOG performance status of 0-1.
Not a fit: Patients with EGFR mutations or ALK translocations, as well as those with active CNS metastases or autoimmune diseases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and personalized therapy for patients with early-stage lung cancer.
How similar studies have performed: Previous studies have shown promising results for neoadjuvant immunotherapy in lung cancer, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Si-Yang Liu
- Email: momogogogo@126.com
- Phone: 13242305346
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.