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NCT Number: NCT07170995

Phase III Study of SHR-8068 Combined With Adebrelimab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer

This study is a randomized, open-label, controlled, multicenter Phase III clinical trial to evaluate the efficacy and safety of SHR-8068 combined with adebrelimab and platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer.

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Key information

Conditions

Advanced or Metastatic Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

Location status: Recruiting

Location contact

Jinming Yu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntary participation and written informed consent.
  • 18-75 years old, no gender limitation.
  • Newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation.
  • Confirmed tumor PD-L1 status prior to randomization.
  • Eastern Cooperative Oncology Group (ECOG) score: 0-1
  • With a life expectancy ≥ 3 months.
  • At least one measurable lesion according to RECIST v1.1.

Exclusion criteria

  • Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression;
  • Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
  • Previous or co-existing malignancies；
  • Have Active or prior documented autoimmune or inflammatory disorders;
  • Active hepatitis B or hepatitis C, or with a history of immunodeficiency;
  • Have an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis.

Treatment and study plan

SHR-8068，adebelizumab and platinum-based chemotherapy

Drug

SHR-8068，adebelizumab and platinum-based chemotherapy

tislelizumab, and platinum-based chemotherapy

Drug

tislelizumab, and platinum-based chemotherapy

Primary outcomes

  1. Progression-Free Survival (PFS) by Blinded Independent Central Review [BICR]

    Time frame: Approximately 32 months.

    PFS (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1]) by BICR was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression)

  2. OS

    Time frame: Approximately 64 months.

    OS was defined as the time from the date of randomization until death due to any cause.

Secondary outcomes

  1. PFS by the investigator

    Time frame: Approximately 32 months.

    PFS (per RECIST 1.1) by the investigator was defined as time from date of randomization until date of objective disease or death (by any cause in the absence of progression)

  2. Objective Response Rate (ORR)

    Time frame: Approximately 32 months.

    ORR (per RECIST 1.1) by BICR or the investigator was defined as the percentage of patients with at least one visit response of complete response (CR) or partial response (PR).

  3. Duration of Response (DoR)

    Time frame: Approximately 32 month

    DoR (per RECIST 1.1) by BICR or the investigator was defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression.

  4. Incidence and Severity of Adverse Events (AEs)

    Time frame: Approximately 64 months.

    Incidence and severity of treatment emergent adverse events (TEAEs) will be reported. Any adverse event occurring at or after the initial administration of study treatment through the day of last dose plus 60 days, or until the start of subsequent anticancer therapy (if earlier), is considered to be treatment emergent.

  5. Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ C30-Lung Cancer Module 13 (QLQ-LC13)

    Time frame: Approximately 64 months.

    The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms and treatment-related symptoms from conventional chemotherapy and radiotherapy. Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration was defined as time from randomization until the date of first clinically meaningful deterioration that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.

Study contacts

Contact information is provided by the study sponsor or research team.

Weixia Li

CONTACT

[email protected]

+86 021-61053363

Yang Wang

CONTACT

[email protected]

+86 021-61053363

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open-label, Controlled, Multicenter Phase III Study of SHR-8068 Combined With Adebrelimab and Platinum-based Chemotherapy Versus Tislelizumab Combined With Platinum-based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Sep 12, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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