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

Recruiting now · Phase 2

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT07241767

Run by

Jiangsu HengRui Medicine Co., Ltd.

People needed

200

Starts

2025-11-12

Expected to finish

2028-11-01

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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