FH-006 combined with other cancer treatments for people with lung cancer
Tests FH-006 alongside other anticancer drugs in adults with lung cancer.
Key facts
- Who runs it
- Jiangsu HengRui Medicine Co., Ltd.
- Where
- Guangzhou, ChinaSee the site
- Trial code
- Registry title
- A Phase II Clinical Study of FH-006 for Injection Combined With Other Anticancer Therapies in Subjects With Lung Cancer
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 200 people, planned
- Started
- 12 Nov 2025
- Expected to end
- Nov 2028
- Type of study
- Interventional, 3 groups
- Treatments tested
- FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin
- FH-006 ; SHR-1316 ; BP102
- FH-006; SHR-1316 ; SHR-8068
- Record updated
- 8 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with locally advanced or metastatic non-small cell lung cancer who cannot have radical surgery or radiotherapy. FH-006 is given together with other anti-tumor treatments.
- Age
- 18 to 75 years old, both ends included.
- Sex
- All sexes can join.
- Disease stage
- Locally advanced or metastatic non-small cell lung cancer, confirmed by histology or cytology, that cannot be treated with radical surgery or radiotherapy. At least one measurable lesion (RECIST v1.1). ECOG score 0 or 1. Expected survival of at least 12 weeks.
- Earlier treatment
- No other anti-tumor treatment within 4 weeks before the first dose. No chest radiation over 30 Gy within 24 weeks before the first dose. Side effects of earlier anti-tumor treatment must have recovered to Grade I or milder.
- Biomarker or test result
- Left ventricular ejection fraction (LVEF) of at least 50%.
Main reasons for not taking part
- Another cancer within the past 5 years
- Active or past spread of cancer to the brain or the membranes around it
- Serious heart or blood vessel disease, or bleeding or clotting problems
- Active, known or suspected autoimmune disease, or immunodeficiency
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 34 criteriaShow less
Who can take part
- 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%
Who cannot take part
- 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
- Receive other anti-tumor treatments within 4 weeks before the first medication
- Severe infection within 4 weeks before the first medication
- 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
- 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
- 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
- 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
- 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
- Has serious cardiovascular and cerebrovascular diseases
- History of clinically significant pulmonary diseases
- Active, known or suspected autoimmune diseases, and a history of autoimmune diseases
- History of immunodeficiency
- Having bleeding tendency, high risk of bleeding, coagulation dysfunction or thrombophilia tendency
- There are other serious physical or mental illnesses or laboratory abnormalities present
- Patients with uncontrollable tumor related pain
- Having severe, unhealed wounds, active ulcers, or untreated fractures
- CT/MRI indicates tumor surrounding or invading large blood vessels
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaContact: Li Zhang (principal investigator)Taking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Part ATreatment being tested
Treatment: FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin
- Part BTreatment being tested
Treatment: FH-006 ; SHR-1316 ; BP102
- Part CTreatment being tested
Treatment: FH-006; SHR-1316 ; SHR-8068
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- FH-006 combined with other cancer treatments for people with lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07241767, who can take part
- Record updated
- 8 April 2026