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Recruiting NCT06754930

A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC

Phase I / Phase II Interventional Non-small Cell Lung Cancer (NSCLC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-1826, SHR-1316, SHR-9839, SHR-8068.
Who it may be relevant to
Registry conditions: Non-small Cell Lung Cancer (NSCLC). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Open Phase IB/II Clinical Study of Safety, Tolerability, and Efficacy of SHR-1826 in Combination With Other Anti-cancer Treatment in Patients With Non-small Cell Lung Cancer

Overview

This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC.

Interventions

  • Drug SHR-1826
    SHR-1826 for injection.
  • Drug SHR-1316
    SHR-1316 for injection.
  • Drug SHR-9839
    SHR-9839 for injection.
  • Drug SHR-8068
    SHR-8068 for injection.
  • Drug Ametinib mesylate
    Ametinib mesylate.
  • Drug BP-102
    BP-102 for injection.
  • Drug Carboplatin
    Carboplatin for injection.

Primary outcome measures

  • Recommended phase II dose (RP2D) [Time frame: Screening up to study completion, an average of 1 year.]
  • Adverse events (AEs) [Time frame: Screening up to study completion, an average of 1 year.]
  • Objective response rate (ORR) [Time frame: Screening up to study completion, an average of 1 year.]
Secondary outcome measures (7)
  • Disease control rate (DCR) [Time frame: Screening up to study completion, an average of 1 year.]
  • Duration of response (DoR) [Time frame: Screening up to study completion, an average of 1 year.]
  • Progression-free survival (PFS) [Time frame: Screening up to study completion, an average of 1 year.]
  • Overall survival (OS) [Time frame: Screening up to study completion, an average of 1 year.]
  • Drug resistant antibody (ADA) to SHR-1826 [Time frame: Screening up to study completion, an average of 1 year.]
  • Blood concentration of SHR-1826 [Time frame: Screening up to study completion, an average of 1 year.]
  • Blood concentration of free toxin [Time frame: Screening up to study completion, an average of 1 year.]

Eligibility criteria

Inclusion criteria

  • Voluntary participation and written informed consent.
  • 18-75 years older, no gender limitation.
  • Eastern Cooperative Oncology Group (ECOG) score: 0-1.
  • With a life expectancy ≥ 3 months.
  • Pathologically diagnosed NSCLC.
  • Be able to provide fresh or archived tumour tissue.
  • At least one measurable lesion according to RECIST v1.1.
  • Adequate organ function.
  • Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.

Exclusion criteria

  • Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
  • Previous or co-existing malignancies.
  • Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded.
  • Uncontrollable tumor-related pain.
  • Have undergone major surgery other than diagnosis or biopsy within 28 days prior to the initial dosing; Minor traumatic surgery within 7 days prior to the first dosing.
  • Received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment.
  • Unresolved CTCAE 5.0>grade 2 toxicities from previous anticancer therapy.
  • With poorly controlled or severe cardiovascular disease.
  • Active hepatitis B and hepatitis C.
  • Patients with a history of immunodeficiency.
  • Severe infection 30 days before the first dose.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Chest Hospital — Shanghai

Identifiers

NCT: NCT06754930 · SHR-1826-201-LC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗