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NCT07241767RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 8 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
200 (estimated)
First submitted
14 Nov 2025
Start date
12 Nov 2025
Primary completion date
Nov 2027
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Diseases
Lung cancer
NCT number
NCT07241767

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 200
  • From 12 Nov 2025 to the primary completion date, Nov 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Lab values

  • There are other serious physical or mental illnesses or laboratory abnormalities present

Other

  • 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

Who the study is looking for

  • 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%

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sun Yat-sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.