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

ConditionLung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin
  • FH-006 ; SHR-1316 ; BP102
  • FH-006; SHR-1316 ; SHR-8068

Treatment groups

200 Participants
are divided into 3 treatment groups