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

NCT07170995 | Recruiting Phase 3

• 1 other identifier: SHR-8068-302
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced or Metastatic Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

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

  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)

  Approximately 32 months.

• OS

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

  Approximately 64 months.

Secondary Outcomes (5)

• PFS by the investigator

  Approximately 32 months.

• Objective Response Rate (ORR)

  Approximately 32 months.

• Duration of Response (DoR)

  Approximately 32 month

• Incidence and Severity of Adverse Events (AEs)

  Approximately 64 months.

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

  Approximately 64 months.

Study Arms (2)

SHR-8068，adebelizumab and platinum-based chemotherapy

EXPERIMENTAL

Drug: SHR-8068，adebelizumab and platinum-based chemotherapy

tislelizumab, and platinum-based chemotherapy

ACTIVE COMPARATOR

Drug: tislelizumab, and platinum-based chemotherapy

Interventions

SHR-8068，adebelizumab and platinum-based chemotherapy DRUG

SHR-8068，adebelizumab and platinum-based chemotherapy

SHR-8068，adebelizumab and platinum-based chemotherapy

tislelizumab, and platinum-based chemotherapy DRUG

tislelizumab, and platinum-based chemotherapy

tislelizumab, and platinum-based chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation and written informed consent.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Platinum Compounds; tislelizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Central Study Contacts

Weixia Li

CONTACT

+86 021-61053363; weixia.li@hengrui.com

Yang Wang

CONTACT

+86 021-61053363; yang.wang.yw263@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: November 18, 2025

Record last verified: 2025-09

Locations

CN (1)