Neoadjuvant Immunotherapy in EGFR-mutant Localized NSCLC

• Status: Not yet recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase II, single-arm, open-label multicenter study that assess clinical feasibility and safety of 3 cycles neoadjuvant Sintilimab plus chemotherapy in EGFR-mutant stage II-IIIB NSCLC followed by optional adjuvant treatment upon investigators' decisions.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong Provincial People's Hospital
• Collaborator: Eli Lilly and Company
• Treatments: Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

1. Age :18 Years to 75 Years;

2. ECOG physical score 0-1 points; expected survival time ≥ 3 months;

3. Pathologically confirmed diagnosis with Stage II-IIIB(N2) NSCLC which harbored sensitive and rare EGFR alteration. 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. At least one measurable target lesion according to the RECIST 1.1 standard;

5. The main organ function meets the following criteria: 1) blood routine: absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80 g / L; 2) blood biochemistry: total bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal value (if liver metastasis, ≤ upper limit of normal value 5 times), serum creatinine ≤ 1.5 times the upper limit of normal;

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. Large panel NGS indicated ALK fusion or any other driver mutations;

3. Histologically confirmed small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);

4. Patients who have previously used any other anti-tumor drugs or radiotherapy;

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;

7. 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;

8. Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures;

9. Patients with low compliance or willingness to take the drugs and surveillance.