Clinical Study of SHR-A1921 Combined With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC

April 2, 2026 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

An Open, Multicenter Phase I/II Trial of SHR-A1921 in Combination With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC

A trial to evaluate the tolerability and efficacy of SHR-A1921 in combination with adbelizumab and SHR-8068 with or without carboplatin in patients with advanced non-small cell lung cancer

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up;
  2. Aged 18-75 at the time of signing the informed consent;
  3. Histologically or cytologically confirmed patients with locally advanced or metastatic non-cellular lung cancer who are not eligible for surgical resection or radical concurrent chemoradiotherapy;
  4. At least one measurable lesion consistent with RECIST v1.1;
  5. ECOG PS score: 0-1;
  6. The organ function level is good;

Exclusion Criteria:

  1. Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.;
  2. Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms;
  3. Previous or co-existing malignant neoplasms;
  4. The presence of any active or known autoimmune disease;
  5. Have clinical symptoms or diseases of the heart that are not well controlled;
  6. People with past or current interstitial pneumonia/interstitial lung disease;
  7. Known allergic reactions to any component of SHR-A1921, Adebrelimab, or severe allergic reactions to other monoclonal antibodies;
  8. Have previously received topoisomerase I inhibitors (including but not limited to irinotecan, Topotecan), TROP-2ADC, or ADC drugs containing topoisomerase I inhibitors; Previously received anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody treatment;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-A1921 combined with Adebrelimab and SHR-8068 with or without carboplatin
Drug: SHR-A1921；Adebrelimab；SHR-8068；carboplatin
SHR-A1921:Specified dose on specified days. SHR-8068: Specified dose on specified days. Adebrelimab: Specified dose on specified days. Carboplatin:Specified dose on specified days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
DLT
Time Frame: 21 days after the first dose
21 days after the first dose
ORR based on RECIST v1.1 assessment.
Time Frame: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years
All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse event
Time Frame: All informed subjects signed informed consent from the beginning to the end of the safety follow-up period， up to 2 years
All informed subjects signed informed consent from the beginning to the end of the safety follow-up period， up to 2 years
DCR based on RECIST v1.1 assessment
Time Frame: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years
All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2024

Primary Completion (Actual)

October 10, 2024

Study Completion (Actual)

October 10, 2024

Study Registration Dates

First Submitted

May 23, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-A1921-205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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