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

NCT07241767 | Recruiting Phase 2

• 1 other identifier: FH-006-201-LC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (3)

Part A

EXPERIMENTAL

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

Part B

EXPERIMENTAL

Drug: FH-006 ; SHR-1316 ; BP102

Part C

EXPERIMENTAL

Drug: FH-006; SHR-1316 ; SHR-8068

Interventions

FH-006; SHR-1316 ; SHR-8068 DRUG

FH-006; SHR-1316 ; SHR-8068

Part C

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

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

Part A

FH-006 ; SHR-1316 ; BP102 DRUG

FH-006 ; SHR-1316 ; BP102

Part B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Central Study Contacts

Xiaouxe Pi

CONTACT

0518-82342973; Xiaoxue.pi@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 21, 2025
• Study Start: November 12, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 8, 2026

Record last verified: 2025-10

Locations

CN (1)