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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

    Drug

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

  • FH-006 ; SHR-1316 ; BP102

    Drug

    FH-006 ; SHR-1316 ; BP102

  • FH-006; SHR-1316 ; SHR-8068

    Drug

    FH-006; SHR-1316 ; SHR-8068

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Part AExperimental treatment 1 intervention
Group B: Part BExperimental treatment 1 intervention
Group C: Part CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Incidence of Treatment-Emergent Adverse Events

Time frame
from first dose to disease progression or death, up to 3 years.
3

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.

Time frame
from first dose to disease progression or death, up to 3 years
4

ORR (Objective Response Rate)

The proportion of patients whose tumor volume shrank to the pre-defined standard (complete or partial response) after treatment.

Time frame
from first dose to disease progression or death, whichever comes first, up to 3 years

Secondary outcomes

1

Duration of response (DoR)

Time frame
from first dose to disease progression or death, whichever comes first, up to 3 years
2

disease control rate (DCR)

Time frame
from first dose to disease progression or death, whichever comes first, up to 3 years
3

progression free survival (PFS)

Time frame
from first dose to disease progression or death, whichever comes first, up to 3 years
4

overall survival (OS)

Time frame
from first dose to disease progression or death, whichever comes first, up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu HengRui Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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