Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC

Launched by GUANGDONG PROVINCIAL PEOPLE'S HOSPITAL · Apr 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with a specific type of lung cancer called Non-Small Cell Lung Cancer (NSCLC) that has rare genetic mutations. The trial is testing the combination of an immunotherapy drug, Toripalimab, along with chemotherapy before surgery to see if it is safe and effective for people with these rare mutations. Patients will receive three cycles of this treatment, and then doctors will decide if any additional treatment is necessary afterward.

To participate in this study, individuals must be at least 18 years old and diagnosed with stage IIB to IIIB NSCLC with certain rare mutations. They need to be in relatively good health, with no major medical issues that could complicate treatment, and should not have received other cancer treatments before. Participants can expect close monitoring and support throughout the trial, and their involvement will help researchers learn more about treating this challenging condition. This study is currently recruiting participants of all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 18 Years and older
• • 2. ECOG physical score 0-1 points; expected survival time ≥ 3 months;
• • 3. Pathologically confirmed diagnosis with Stage IIB-IIIB NSCLC which harbored rare driver alteration including RET fusions, BRAF (V600E or non-V600E but confirmed driver mutations), ERBB2 exon20 insertion, MET amplification (FISH confirmed) or exon 14 skipping. Suspected N2 disease should be confirmed by either mediastinoscopy or EBUS. N1 disease could be determined through PET/CT but biopsy of primary lung cancer is needed;
• • 4. Lung function capacity capable of tolerating the proposed lung surgery
• • 5. Available tissue of tumor for PD-L1 test
• • 6. Subjects voluntarily joined the study and signed informed consent, with good compliance to follow-up.
• Exclusion Criteria:
• • 1. Stage I and stage IV NSCLC;
• • 2. Patients who have previously used any other anti-tumor drugs or radiotherapy;
• • 3. Large panel NGS indicated sensitive EGFR alteration, ALK fusion, ROS1 fusion or any other driver mutations combined with MDM2/MDM4 amplification;
• • 4. Histologically confirmed small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);
• • 5. A history of active bleeding within the 6 months before enrollment, or receiving thrombolysis or anticoagulant therapy, or the investigator believes that there is a clear tendency to gastrointestinal bleeding (such as esophageal varices with bleeding risk, local activity) Ulcer lesions, etc.) or active hemoptysis;
• • 6. Patients with any underlying disease that investigators consider it may affect patient's prognosis including sever cardiovascular, pulmonary disease or serious infections; Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients with total gastrectomy;
• • 7. Known or suspected autoimmune disease with activity. Participants may be enrolled if they have type 1 diabetes, hypothyroidism that requires only hormone replacement therapy, skin diseases that require no systemic treatment (such as purpura, psoriasis, or hair loss), or other conditions that are not expected to return without external trigger.
• • 8. Patients with active hepatitis B (positive for HBsAg) or hepatitis C (positive for HCV RNA).
• • 9. Patients with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
• • 10. Patients with other active malignancies within five years
• • 11. Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures;
• • 12. Patients with low compliance or willingness to take the drugs and surveillance.