NCT07241767 A Phase II Clinical Study of FH-006 for Injection Combined With Other Anticancer Therapies in Subjects With Lung Cancer

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 200 participants in total. It began in 2025-11-12 with a primary completion date of 2027-11.

Brief Summary

Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in combination with other anti-tumor treatments in lung cancer subjects, and determine the recommended dose (RP2D) and initial efficacy for phase II clinical trials.

Eligibility Criteria

Inclusion Criteria: 1. Age range: 18-75 years old (including both ends), gender is not limited. 2. Subjects with locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology as unsuitable for radical surgery or radiotherapy treatment 3. ECOG score is 0 or 1 4. Expected survival period ≥ 12 weeks 5. According to the RECIST v1.1 standard, there must be at least one measurable lesion. 6. Good level of organ function 7. The patient voluntarily joined this study and signed informed consent 8. Left ventricular ejection fraction (LVEF) ≥ 50% Exclusion Criteria: 1. Suffering from other malignant tumors within the past 5 years 2. Subjects with active central nervous system (CNS) tumor metastasis, a history of meningeal metastasis, or current meningeal metastasis 3. Patients with uncontrollable tumor related pain 4. Has serious cardiovascular and cerebrovascular diseases 5. Significant clinically significant bleeding symptoms occurred within 3 months prior to the first study medication 6. Uncontrollable third interstitial fluid accumulation within 2 weeks of initial study medication 7. History of clinically significant pulmonary diseases 8. Receive other anti-tumor treatments within 4 weeks before the first medication 9. Severe infection within 4 weeks before the first medication 10. Active, known or suspected autoimmune diseases, and a history of autoimmune diseases. 11. History of immunodeficiency 12. Individuals with active pulmonary tuberculosis infection within the year prior to enrollment 13. Chest radiation therapy patients who received\>30 Gy within 24 weeks prior to the first use of the investigational drug 14. The adverse reactions of previous anti-tumor treatments have not yet recovered to ≤ Grade I 15. Surgical treatment of important organs within 4 weeks prior to the first use of medication 16. Use attenuated live vaccine within 28 days prior to the first use of the investigational drug 17. There are other serious physical or mental illnesses or laboratory abnormalities present 18. 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 19. Having bleeding tendency, high risk of bleeding, coagulation dysfunction or thrombophilia tendency 20. Previously experienced hypertensive crisis or hypertensive encephalopathy 21. Suffering from significant vascular disease within 6 months prior to the first use of medication 22. Have undergone a biopsy or other minor surgery within 7 days prior to the first use of medication 23. Having severe, unhealed wounds, active ulcers, or untreated fractures 24. Gastrointestinal perforation occurred within 6 months prior to the first use of medication 25. 24-hour proteinuria quantification ≥ 1g within 7 days before the first medication 26. CT/MRI indicates tumor surrounding or invading large blood vessels

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