Predicting cancer treatment outcomes in early stage lung cancer
Analysis of Variables Predicting Pathological Complete Response and Immune Related Adverse Events in Patients With Resectable Non-Small Cell Lung Cancer Receiving Neoadjuvant Immunotherapy With Chemotherapy - A Prospective Cohort Study
This study is trying to find out which factors can help predict how well early-stage lung cancer patients will respond to a combination of chemotherapy and immunotherapy before surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Drugs / interventions | prednisone, chemotherapy, immunotherapy, nivolumab |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT06250829 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze predictors of pathological complete response (pCR) in patients with resectable early-stage non-small cell lung cancer (NSCLC) undergoing neoadjuvant chemotherapy combined with immunotherapy. By utilizing a range of parameters that reflect both tumor characteristics and the immune system's integrity, the study seeks to develop a predictive model for pCR. The findings could help identify which patients are likely to benefit from this treatment approach and understand the factors influencing treatment responses and immune-related adverse events.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed Stage IB, II, or IIIA NSCLC who are considered to have resectable disease.
Not a fit: Patients with locally advanced, unresectable, or metastatic disease, as well as those with specific genetic mutations or active autoimmune diseases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient selection for neoadjuvant immunotherapy, enhancing treatment outcomes and reducing unnecessary side effects.
How similar studies have performed: Other studies have shown promising results with similar predictive modeling approaches in cancer treatment, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. Participants with histologically confirmed Stage IB (≥ 4 cm), II, IIIA (N2) NSCLC (as per the 8th American Joint Committee on Cancer (AJCC)) who are considered to have resectable disease. 2. Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). 3. Participants must have tumor tissue available for PD-L1 immunohistochemical (IHC) testing. 4. Eastern Cooperative Group (ECOG) Performance Status 0-2. 5. Able to give informed consent. Exclusion Criteria: * 1. Presence of locally advanced, unresectable, or metastatic disease. 2. Participants with known EGFR mutations, ALK or ROS1 translocation. 3. Subjects with active, known, or suspected autoimmune disease (except subjects with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment). 4. Subjects with a condition requiring systemic treatment with either corticosteroids (10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. 5. Subjects with previous malignancies are excluded unless a complete remission was achieved at least 5 years prior to study entry and no additional therapy is required or anticipated to be required during the study (non-melanoma skin cancer and other indolent malignancies not requiring any treatment and that are unlikely to affect blood-based biomarkers are allowed).
Where this trial is running
London, Ontario
- London Regional Cancer Program — London, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Saurav Verma, MD
- Email: saurav.verma@lhsc.on.ca
- Phone: 519 685 8500
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.