FH-006 combined with other anticancer therapies for lung cancer

An Open Label, Multicenter Phase II Clinical Study on the Safety, Tolerability, and Efficacy of FH-006 Injection Combined With Other Anti-tumor Therapies in Lung Cancer Subjects

This study will see if giving FH-006 together with other anti-cancer drugs is safe and shows early benefit for people with advanced non-small cell lung cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07241767 on ClinicalTrials.gov

What this trial studies

This Phase II, open-label interventional study enrolls adults with locally advanced or metastatic non-small cell lung cancer who are not candidates for curative surgery or radiotherapy. Participants receive FH-006 by injection in combination with other anticancer agents in separate cohorts (including SHR-1316, BP102, cisplatin or carboplatin, and SHR-8068) with dose-finding to determine the recommended Phase II dose (RP2D). Primary assessments include safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity measured by RECIST v1.1 in patients with measurable disease. The trial requires ECOG 0–1, adequate organ function, measurable lesions, and left ventricular ejection fraction ≥50%, and is conducted at Sun Yat-sen University Cancer Center in Guangzhou.

Who should consider this trial

Good fit: Adults 18–75 with locally advanced or metastatic non-small cell lung cancer who have ECOG 0–1, at least one measurable lesion, adequate organ function, LVEF ≥50%, and who can give informed consent.

Not a fit: Patients with another malignancy within the past five years, active or untreated CNS metastases or meningeal disease, uncontrolled tumor-related pain, serious cardiovascular or cerebrovascular disease, or recent clinically significant bleeding are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, the combination could provide a new treatment option that improves disease control for people with advanced non-small cell lung cancer.

How similar studies have performed: Other combination approaches pairing novel biologics or immunotherapies with chemotherapy have shown benefit in NSCLC, but FH-006 itself is investigational and has not yet demonstrated proven efficacy.

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

Where this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: Xiaouxe Pi

Conditions Lung Cancer