Phase Ib/II Study of Almonertinib Combined With SHR-1701 in the Treatment of Relapsed or Advanced Non-small Cell Lung Cancer

Inclusion criteria

• Patients voluntarily joined the study and signed informed consent
• Age 18~75 years old, both male and female
• Advanced NSCLC diagnosed by histology or cytology, or recurrent NSCLC after radical treatment such as surgery, radiotherapy, chemoradiotherapy
• At least one measurable lesion based on RECIST v1.1 criteria
• ECOG PS score: 0-1
• Have a life expectancy of at least 3 months
• Fertile women must have a negative serum pregnancy test within 3 days before the first dose and must be non-lactating

Exclusion criteria

• Untreated Brain metastases with clinical symptoms; Or accompanied by meningeal metastasis, spinal cord compression，etc.
• Uncontrolled pleural, pericardial, or abdominal effusion with clinical symptoms
• Suffering from other malignant tumors in the past 3 years or at the same time
• Presence of any active or known autoimmune disease
• Subjects who had been systematically treated with corticosteroids (>10 mg/ day of prednisone or other equivalent hormone) or other immunosuppressive agents within 2 weeks prior to the first dose (randomization)
• Any severe or uncontrolled ocular lesions that, in the judgment of the investigator, may increase the subject's safety risk
• Have clinical symptoms or diseases of the heart that are not well controlled
• Patients with hypertension who are not well controlled by antihypertensive medication
• Any bleeding event of grade 2 or more or hemoptysis (volume of hemoptysis ≥2ml in a single episode) occurring within 2 weeks before the first dose (randomization); Clinically significant bleeding symptoms or definite bleeding tendency before the first medication (randomization)
• Have known history of serious infections within 1 month prior to the first dose(randomization), including but not limited to infectious complications that require hospitalization, bacteremia, and severe pneumonia; use antibiotics within 1 week prior to the first dose(randomization); have any active infections requiring intravenous systemic therapy, or have a fever > 38.5°C of unknown cause before the first dose(randomization).
• Have active or prior documented interstitial pneumonia/interstitial lung disease or pneumonitis that requires glucocorticoid treatment (e.g., radiation pneumonitis); Have active pneumonia at present
• Have active pulmonary tuberculosis.
• Have known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS). Have known active hepatitis B or C.
• Had received lung radiation therapy within 6 months before the first dose (randomization); Had received major surgical treatment (except diagnostic surgery), systemic chemotherapy, immunotherapy, or other investigational drugs within 4 weeks prior to the first medication (randomization); Received palliative radiotherapy within 2 weeks before the first dose (randomization); Oral administration of molecular targeted drugs, less than 5 half-lives before discontinuation of the drug to the first dose (randomization); Failure to recover from toxicity and/or complications of previous interventions to NCI-CTC AE grade≤1