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

NCT ID: NCT07241767

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-12
• Study Completion Date: 2028-11-30

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A

Group Type: EXPERIMENTAL

FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin

Intervention Type: DRUG

FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin

Part B

Group Type: EXPERIMENTAL

FH-006 ; SHR-1316 ; BP102

Intervention Type: DRUG

FH-006 ; SHR-1316 ; BP102

Interventions

FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin

FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin

Intervention Type: DRUG

FH-006 ; SHR-1316 ; BP102

FH-006 ; SHR-1316 ; BP102

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaouxe Pi

Role: CONTACT

Xiaoxue.pi@hengrui.com

0518-82342973

Other Identifiers

FH-006-201-LC

Identifier Type: -

Identifier Source: org_study_id