Health TrialsbyHealthPanel

A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC

ConditionNSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

This study is an open-label, multicenter Phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in patients with NSCLC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

ECOG performance score of 0-1.

Life expectancy ≥ 3 months.

Have at least one measurable tumor lesion per RECIST v1.1.

Disqualifiers

Subjects with active central nervous system metastases or meningeal metastases;

History of serious cardiovascular and cerebrovascular diseases;

Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;

Severe infection within 4 weeks prior to the first dose;

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-1826；Adebrelimab；SHR-8068；Bevacizumab

    Drug

    Drug: Drug: SHR-1826 Administration by intravenous infusion for a cycle of 3 weeks. Drug: Adebrelimab Administration by intravenous infusion for a cycle of 3 weeks. Drug: SHR-8068 Administration by intravenous infusion for a cycle of 6 weeks. Drug: Bevacizumab Administration by intravenous infusion for a cycle of 3 weeks.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Arm AExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events (AEs) /serious adverse events(SAEs)

Time frame
approximately 2 years
2

Overall response rate (ORR)

Time frame
approximately to 2 years

Secondary outcomes

1

Duration of response (DoR)

Time frame
approximately to 2 years
2

Disease control rate (DCR)

Time frame
approximately to 2 years
3

Progression-free survival (PFS)

Time frame
approximately to 2 years
4

Overall survival (OS)

Time frame
approximately to 5 years after last subject enrolled

Other outcomes

Sponsors and contacts

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

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now