Lung CancerPhase 2NCT07241767
A Phase II Clinical Study of FH-006 for Injection Combined With Other Anticancer Therapies in Subjects With Lung Cancer
A Phase 2 study testing FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin, FH-006 ; SHR-1316 ; BP102 and FH-006; SHR-1316 ; SHR-8068 in people with Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin, FH-006 ; SHR-1316 ; BP102 and FH-006; SHR-1316 ; SHR-8068
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2025to Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
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- 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
- Use attenuated live vaccine within 28 days prior to the first use of the investigational drug
- There are other serious physical or mental illnesses or laboratory abnormalities present
- 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
- Having bleeding tendency, high risk of bleeding, coagulation dysfunction or thrombophilia tendency
- 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
- Having severe, unhealed wounds, active ulcers, or untreated fractures
- 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
- CT/MRI indicates tumor surrounding or invading large blood vessels
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang
About this study
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
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
- Being tested
- FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin, FH-006 ; SHR-1316 ; BP102, FH-006; SHR-1316 ; SHR-8068
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; CarboplatinDrug
FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin
FH-006 ; SHR-1316 ; BP102Drug
FH-006 ; SHR-1316 ; BP102
FH-006; SHR-1316 ; SHR-8068Drug
FH-006; SHR-1316 ; SHR-8068
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Not described Receives: Drug: FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin |
| Part B | Experimental | Not described Receives: Drug: FH-006 ; SHR-1316 ; BP102 |
| Part C | Experimental | Not described Receives: Drug: FH-006; SHR-1316 ; SHR-8068 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT (Dose-limiting toxicity)：Severe toxicity occurred 21 or 28 days after each subject received their first systemic anticancer treatment.
Measured: 21or28 days after the first administration of each subject
Incidence of Treatment-Emergent Adverse Events
Measured: 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.
Measured: 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.
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
Secondary outcomes (4)
Duration of response (DoR)
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
disease control rate (DCR)
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
progression free survival (PFS)
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
overall survival (OS)
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start12 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241767
- Sponsor's protocol ID
- FH-006-201-LC
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07241767
- Acronym / sponsor ID
- FH-006-201-LC
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; CarboplatinFH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin | Drug | Part A |
| FH-006 ; SHR-1316 ; BP102FH-006 ; SHR-1316 ; BP102 | Drug | Part B |
| FH-006; SHR-1316 ; SHR-8068FH-006; SHR-1316 ; SHR-8068 | Drug | Part C |
Primary outcome
DLT (Dose-limiting toxicity)：Severe toxicity occurred 21 or 28 days after each subject received their first systemic anticancer treatment.
Time frame: 21or28 days after the first administration of each subject
Incidence of Treatment-Emergent Adverse Events
Time frame: 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.
Time frame: from first dose to disease progression or death, up to 3 years
This was determined through a comprehensive evaluation of safety data and pharmacokinetic characteristics.
ORR (Objective Response Rate)
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
The proportion of patients whose tumor volume shrank to the pre-defined standard (complete or partial response) after treatment.
4 secondary outcomes
Duration of response (DoR)
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
disease control rate (DCR)
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
progression free survival (PFS)
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
overall survival (OS)
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin, FH-006 ; SHR-1316 ; BP102 and FH-006; SHR-1316 ; SHR-8068 in people with Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaouxe Pi (0518-82342973, Xiaoxue.pi@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (Dose-limiting toxicity)：Severe toxicity occurred 21 or 28 days after each subject received their first systemic anticancer treatment. (time frame: 21or28 days after the first administration of each subject). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.