A Phase II Clinical Study of FH-006 for Injection Combined With Other Anticancer Therapies in Subjects With Lung Cancer

Inclusion criteria

• Age range: 18-75 years old (including both ends), gender is not limited.
• Subjects with locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology as unsuitable for radical surgery or radiotherapy treatment
• ECOG score is 0 or 1
• Expected survival period ≥ 12 weeks
• According to the RECIST v1.1 standard, there must be at least one measurable lesion.
• Good level of organ function
• The patient voluntarily joined this study and signed informed consent
• Left ventricular ejection fraction (LVEF) ≥ 50%

Exclusion criteria

• Suffering from other malignant tumors within the past 5 years
• Subjects with active central nervous system (CNS) tumor metastasis, a history of meningeal metastasis, or current meningeal metastasis
• Patients with uncontrollable tumor related pain
• Has serious cardiovascular and cerebrovascular diseases
• Significant clinically significant bleeding symptoms occurred within 3 months prior to the first study medication
• Uncontrollable third interstitial fluid accumulation within 2 weeks of initial study medication
• History of clinically significant pulmonary diseases
• Receive other anti-tumor treatments within 4 weeks before the first medication
• Severe infection within 4 weeks before the first medication
• Active, known or suspected autoimmune diseases, and a history of autoimmune diseases.
• History of immunodeficiency
• Individuals with active pulmonary tuberculosis infection within the year prior to enrollment
• Chest radiation therapy patients who received>30 Gy within 24 weeks prior to the first use of the investigational drug
• The adverse reactions of previous anti-tumor treatments have not yet recovered to ≤ Grade I
• Surgical treatment of important organs within 4 weeks prior to the first use of medication
• Use attenuated live vaccine within 28 days prior to the first use of the investigational drug
• There are other serious physical or mental illnesses or laboratory abnormalities present
• Pregnant, lactating women, or female participants who plan to become pregnant within 14 months after the last use of the investigational drug during the study period
• Having bleeding tendency, high risk of bleeding, coagulation dysfunction or thrombophilia tendency
• Previously experienced hypertensive crisis or hypertensive encephalopathy
• Suffering from significant vascular disease within 6 months prior to the first use of medication
• Have undergone a biopsy or other minor surgery within 7 days prior to the first use of medication
• Having severe, unhealed wounds, active ulcers, or untreated fractures
• Gastrointestinal perforation occurred within 6 months prior to the first use of medication
• 24-hour proteinuria quantification ≥ 1g within 7 days before the first medication
• CT/MRI indicates tumor surrounding or invading large blood vessels