Health TrialsbyHealthPanel

Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects

ConditionLocally Advanced or Metastatic Non-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

Evaluate the safety, tolerability, and objective response rate (ORR) of SHR2554 tablets in combination with other anti-tumor treatments in subjects with locally advanced or metastatic non-small cell lung cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age range of 18-75 years old (including both ends), gender not limited;

Patients with locally advanced unresectable or metastatic non-small cell lung cancer diagnosed by pathology

ECOG score is 0 or 1

Expected survival period ≥ 12 weeks

Disqualifiers

Having difficulty swallowing or malabsorption syndrome or any other uncontrolled gastrointestinal disease (such as nausea, diarrhea, or vomiting), having undergone gastrectomy or gastric banding surgery, etc

Symptomatic or active central nervous system tumor metastasis

Previously or simultaneously suffering from other malignant tumors

Spinal cord compression that cannot be cured by surgery and/or radiotherapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR2554; SHR-A2102

    Drug

    SHR2554 tablets combined with SHR-A2102 for injection, with a cycle of 21 days

  • SHR2554; Adabelimumab

    Drug

    SHR2554 tablets combined with Adabelimumab, with a cycle of 21 days

  • SHR2554; SHR-1701

    Drug

    SHR2554 tablets combined with SHR-1701 injection, with a cycle of 21 days

Treatment groups

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

Trial outcomes

Primary outcomes

1

DLT

Time frame
21days after the first administration of each subject
2

AE

Time frame
from Day1 to 30 days after last dose
3

Incidence and severity of serious adverse events (SAE)

Time frame
from Day1 to 30 days after last dose
4

ORR

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

Secondary outcomes

1

Immunogenic indicators: anti-SHR-A2102 antibody (ADA)

Time frame
through study completion, an average of 2 years
2

Duration of response (DoR)

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

disease control rate (DCR)

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

progression free survival (PFS)

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
Apply now