Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC

Launched by GUANGDONG PROVINCIAL PEOPLE'S HOSPITAL · Mar 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with non-small cell lung cancer (NSCLC) who have a specific genetic change called an EGFR mutation. The trial will involve giving participants a medication called almonertinib before surgery, followed by a combination of chemotherapy and another drug called adebrelimab. The goal is to see if this treatment is safe and effective in helping patients who are eligible for surgery to remove their tumors.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of resectable stage II-IIIB non-small cell lung cancer with an EGFR mutation. They should also be in good overall health, with a performance status that indicates they can carry out daily activities. Participants can expect to receive the study treatments, regular check-ups, and support throughout their participation. It’s important to know that patients with certain conditions, such as other types of lung cancer or active autoimmune diseases, may not be eligible for this trial. If you or a loved one is interested in participating, it's a good idea to discuss it further with your healthcare team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female，Age: 18 Years and older,
• • 2. Subjects voluntarily joined the study and signed informed consent,
• • 3. pathological proven resectable stage II-IIIB non small cell lung cancer (AJCC 8th edition),
• • 4. ECOG PS=0 or 1,
• • 5. resectable or potentially resectable, or resectability discussed by MDT,
• • 6. harboring EGFR mutation: Ex19del, L858R, T790M, G719X, Exon20 insertions, S768I or L861Q
• • 7. measurable lesion as per RECIST1.1.
• Exclusion Criteria:
• • 1. pathologica or cytological proven small cell lung cancer, mixed small cell lung cancer or other than non small cell lung cancer,
• • 2. non small cell lung cancer harboring other driver gene alteration with approved targeted drugs,
• • 3. with malignant plural effusion,
• • 4. previous treatment to non small cell lung cancer other than this regimen,
• • 5. received thoracic radiotherapy,
• • 6. currently enrolled in other clinical trial,
• • 7. active or known or suspected autoimmune disease.