Observational study of Atezolizumab with chemotherapy for lung cancer treatment
A Real-World Study of Atezolizumab in Combination With Platinum-Based Doublet Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-IIIB Driver Gene-Negative Non-Small Cell Lung Cancer (NSCLC)
This study looks at how well Atezolizumab works with chemotherapy for patients with early-stage lung cancer before surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hunan Province Tumor Hospital Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT05991206 on ClinicalTrials.gov |
What this trial studies
This observational study collects data on the use of Atezolizumab in combination with platinum-based doublet chemotherapy as neoadjuvant therapy for patients with resectable stage II to IIIB non-small cell lung cancer (NSCLC). The study aims to gather epidemiological data without intervening in the current medical practices of the participants. Patients will be monitored to assess the effectiveness and outcomes of this treatment approach in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with previously untreated, histologically confirmed resectable stage II, IIIA, or IIIB NSCLC.
Not a fit: Patients with unresectable NSCLC or those who have received prior treatment for their lung cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of Atezolizumab combined with chemotherapy, potentially improving treatment strategies for NSCLC.
How similar studies have performed: While this study is observational, similar approaches combining immunotherapy with chemotherapy have shown promise in other trials, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must be ≥18 years. * Provision of fully informed consent prior to any study specific procedures. * Previously untreated, histologically confirmed resectable stage II, IIIA, IIIB (N2) (AJCC stage VIII) NSCLC; cTNM stage can be confirmed by PET-CT or pathological biopsy; resectable stage II non-small cell lung cancer is defined as radical resection as assessed by a qualified thoracic surgeon; resectable is resectable and potentially resectable as defined by the Expert Consensus on Multidisciplinary Diagnosis and Treatment of Stage III Non-small Cell Lung Cancer (2019 version); resectable includes IIIA (N0-1), some single-station mediastinal lymph node metastases with N2 and some T4 (satellite nodules present in adjacent lobes) N1; potentially resectable includes some stage IIIA and IIIB, including single-station N2 mediastinal lymph node short diameter \< 3 cm stage IIIA NSCLC, potentially resectable T3 or T4 central tumors; Solid/solid pulmonary nodules, not pure ground-glass opacity (GGO), are strongly recommended for pathological puncture verification. * According to the RECIST 1.1 standard, the patient must have at least one measurable lesion. Exclusion Criteria: * None Exclusion Criteria: \-
Where this trial is running
Changsha, Hunan
- Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Yongchang Zhang, MD
- Email: zhangyongchang@csu.edu.cn
- Phone: +8613873123436
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.