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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

A Phase II Clinical Study of FH-006 for Injection Combined With Other Anticancer Therapies in Subjects With Lung Cancer (NCT07241767) is a Phase 2 interventional studying Lung Cancer, sponsored by Jiangsu HengRui Medicine Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Lung Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 200 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Lung Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 8. Left ventricular ejection fraction (LVEF) ≥ 50% Who Should NOT Join This Trial: 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 conditions (where your immune system attacks your own body)s, and a history of autoimmune conditions (where your immune system attacks your own body)s. 11. History of weakened immune system 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

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

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

DRUG

FH-006 ; SHR-1316 ; BP102

FH-006 ; SHR-1316 ; BP102

DRUG

FH-006; SHR-1316 ; SHR-8068

FH-006; SHR-1316 ; SHR-8068

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07241767), the sponsor (Jiangsu HengRui Medicine Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07241767 clinical trial studying?

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 full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07241767?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07241767?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07241767. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07241767. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.