Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Guangzhou Medical University

About this trial

Previous trials, such as ADURA and CTONG, have demonstrated the benefits of neoadjuvant targeted therapy in patient with EGFR mutations , which can effectively reduce the extent of tumors and improve the survival outcomes. However, clinical trials of neoadjuvant targeted therapy in NSCLC have rarely enrolled patients with EGFR-mutated lung squamous cell carcinoma due to its rarity, which means that the safety and feasibility of neoadjuvant osimertinib in patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma remains controversial.

Eligibility criteria

Qualifiers

Chest CT and pathological examination confirmed as resectable II-IIIB lung squamous cell carcinoma;

Gene text confirmed EGFR mutation;

PET-CT confirmed no metastasis;

ECOG physical status score 0-1;

Disqualifiers

Patients with other malignant tumors in the five years before the start of this trial.

Complicated with unstable systemic diseases, including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure [higher than II (New York College of Cardiology)], severe arrhythmias, liver, kidney or metabolic diseases;

Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndrome requiring systemic treatment;

A history of active bleeding or embolism within 6 months, or received thrombolysis or anticoagulation therapy, or the researchers believe that there is an obvious tendency of gastrointestinal bleeding (such as esophageal varices have the risk of bleeding, local active ulcer lesions, etc.);

Trial design

Treatments tested in this trial

  • Osimertinib

Treatment groups

51 Participants
are divided into 1 treatment group