Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 70Years
All Genders
NCT06512051

A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Non-small Cell Lung Cancer

Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2025-12-23

248

Participants Needed

1

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with Adebrelimab with or without other Antitumor Therapy in Advanced or Metastatic Non-small cell lung Cancer. To explore the reasonable dosage of SHR-A2102 for Advanced or Metastatic Non-small cell lung Cancer

CONDITIONS

Official Title

A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Non-small Cell Lung Cancer

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to give informed consent and comply with treatment and study procedures
  • Age between 18 and 70 years, any gender
  • Provide archived or fresh tumor tissue for testing
  • At least one measurable tumor lesion per RECIST v1.1 criteria
  • Diagnosed with locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology, inoperable and not suitable for radical radiotherapy or chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Expected survival of at least 12 weeks
  • Adequate organ function
  • Use of highly effective contraception for males with partners of childbearing potential and for fertile females
Not Eligible

You will not qualify if you...

  • Active or symptomatic brain metastases
  • Other malignancies unless in complete remission for at least 5 years and considered cured
  • Uncontrolled moderate to large pleural, peritoneal, or pericardial effusion
  • Uncontrolled tumor-related pain
  • Antitumor therapy received within 4 weeks prior to study start
  • Non-chest radiation therapy over 30 Gy within 28 days before dosing, chest radiation over 30 Gy within 24 weeks before dosing, or any radiation therapy within 14 days before dosing
  • Participation in another clinical trial with recent dosing within 4 weeks or within 5 half-lives of prior investigational drug
  • Recent major or elective surgery within specified timeframes
  • Ongoing toxicity from previous antitumor therapy above mild level
  • Systemic immunosuppressive therapy within 14 days before study
  • History or current interstitial/non-infectious pneumonia requiring treatment
  • Active or suspected autoimmune disease
  • Severe cardiovascular or cerebrovascular disease
  • Severe infection within 28 days before first dose
  • Active hepatitis B or C
  • Active pulmonary tuberculosis within 1 year
  • Significant bleeding within 1 month
  • History of immune deficiency
  • Use of live attenuated vaccines within 28 days before or during study
  • Pregnancy or planning pregnancy during study
  • Uncontrollable mental illness or substance abuse
  • Any conditions increasing study risk or interfering with results per investigator judgment
  • Bleeding disorders or high bleeding risk (for patients using bevacizumab)
  • Poorly controlled hypertension or history of hypertensive crisis (for bevacizumab patients)
  • Major vascular disease within 6 months (for bevacizumab patients)
  • Use of anticoagulants or platelet inhibitors shortly before dosing (for bevacizumab patients)
  • Severe untreated wounds, ulcers, fractures, or history of gastrointestinal perforation (for bevacizumab patients)
  • Tumor involvement of major blood vessels (for bevacizumab patients)
  • Prior systemic anti-angiogenic treatment including VEGF/VEGFR inhibitors (for bevacizumab patients)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

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Research Team

Y

Yunfei Zhang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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