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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin; Drug: FH-006 ; SHR-1316 ; BP102; Drug: FH-006; SHR-1316 ; SHR-8068

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaouxe Pi; Phone Number: 0518-82342973; Email: Xiaoxue.pi@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-Sen University Cancer Center
      • Principal Investigator: Li Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A	Drug: FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin; FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin
Experimental: Part B	Drug: FH-006 ; SHR-1316 ; BP102; FH-006 ; SHR-1316 ; BP102
Experimental: Part C	Drug: FH-006; SHR-1316 ; SHR-8068; FH-006; SHR-1316 ; SHR-8068

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLT (Dose-limiting toxicity)：Severe toxicity occurred 21 or 28 days after each subject received their first systemic anticancer treatment.		21or28 days after the first administration of each subject
Incidence of Treatment-Emergent Adverse Events		from first dose to disease progression or death, up to 3 years.
RP2D (Recommended Phase II Dose)：This was determined through a comprehensive evaluation of safety data and pharmacokinetic characteristics.	This was determined through a comprehensive evaluation of safety data and pharmacokinetic characteristics.	from first dose to disease progression or death, up to 3 years
ORR (Objective Response Rate)	The proportion of patients whose tumor volume shrank to the pre-defined standard (complete or partial response) after treatment.	from first dose to disease progression or death, whichever comes first, up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of response (DoR)	from first dose to disease progression or death, whichever comes first, up to 3 years
disease control rate (DCR)	from first dose to disease progression or death, whichever comes first, up to 3 years
progression free survival (PFS)	from first dose to disease progression or death, whichever comes first, up to 3 years
overall survival (OS)	from first dose to disease progression or death, whichever comes first, up to 3 years

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Organic Chemicals; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Platinum Compounds; Carboplatin; Cisplatin
• Other Study ID Numbers: FH-006-201-LC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No