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Not yet recruiting NCT06465238

Clinical Study of SHR-A1921 or SHR-A2009 in Previously Treated Advanced NSCLC

Phase II Interventional 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-A2009, SHR-A1921.
Who it may be relevant to
Registry conditions: 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 Phase II Study of the Efficacy and Safety of SHR-A1921 or SHR-A2009 in Patients With Previously Treated Advanced NSCLC

Overview

This study is an open-label Phase II clinical trial to evaluate the safety and efficacy of SHR-A1921 or SHR-A2009 in patients with advanced NSCLC who progressed after standard therapy.

Interventions

  • Drug SHR-A2009
    Treatment group: Subjects will receive an intravenous infusion of SHR-A2009 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.
  • Drug SHR-A1921
    Treatment group: Subjects will receive an intravenous infusion of SHR-A1921 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

Primary outcome measures

  • Overall response rate (ORR) [Time frame: up to 12 months]
Secondary outcome measures (6)
  • Progression-free survival (PFS) [Time frame: up to 12 months]
  • overall survival (OS) [Time frame: up to 24 months]
  • Duration of response(DoR ) [Time frame: up to 12 months]
  • Disease control rate (DCR) [Time frame: up to 12 months]
  • Time to Response (TTR) [Time frame: up to 12 months]
  • The incidence and severity of adverse events (AEs) [Time frame: from Day1 to 90 days after last dose]

Eligibility criteria

Inclusion criteria

  • Voluntary participation and written informed consent;
  • Aged 18-75 years (inclusive), males and females;
  • Has a histologically or cytologically confirmed diagnosis of metastatic NSCLC (according to 8th AJCC/UICC Classification);
  • Has failed to standard therapy and disease progressed after antibody-conjugated drugs therapy;
  • Has at least 1 measurable lesion per RECIST 1.1;
  • Patients with ECOG score of 0-1;
  • Life expectancy ≥12 weeks;
  • Have adequate organ function;
  • Participants agrees to use contraception, and be abstinent from heterosexual intercourse during the treatment period and for ≥180 days after the last dose of study treatment.

Exclusion criteria

  • Histologically or cytologically confirmed presence of small-cell lung cancer or other benefit-limiting tumor components;
  • Untreated brain metastasis or accompanied by meningeal metastases, spinal cord compression;
  • Cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms;
  • Subjects who have received systemic anti-tumor treatments prior to the initiation of the study treatment;
  • Has received major organ surgery or high-intensity thoracic radiotherapy within before first dose of study therapy；
  • Has a history of a second malignancy;
  • Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
  • Subjects with active pulmonary tuberculosis infection；
  • Serious infection before the first dose；
  • Uncontrolled cardiac diseases or symptoms;
  • Arterial/venous thrombosis events occurred before the first dose；
  • Hypertension that can not be well controlled through antihypertensive drugs，previous hypertensive crisis or hypertensive encephalopathy；
  • Has a history of active chronic enteritis;
  • Has a history of bleeding prior to the initiation of the study treatment;
  • History of immunodeficiency disease or organ transplant;
  • Subjects with active hepatitis B or active hepatitis C;
  • Has unresolved toxicities from previous anticancer therapy;
  • Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921or SHR-A2009;
  • Subjects with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients.

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

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Henan cancer hospital — Zhengzhou

Identifiers

NCT: NCT06465238 · NSCLC-IIT-SHRA2009-SHRA1921

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗