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NCT Number: NCT06589778

A Study of SHR-A2102 in Combination With Adebrelimab and SHR-8068 in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This study is a multicenter, open-label, dose-finding/efficacy-expanding Phase IB/II clinical trial to evaluate SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer. The study consists of two phases: Phase IB to explore the safety/tolerability of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer; Phase II: To explore the efficacy of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer.

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Key information

Conditions

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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location status: Recruiting

Location contact

Hua Zhong

CONTACT

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
  • Age 18~70 years old.
  • Pathologically confirmed unresectable locally advanced/metastatic non-small cell lung cancer.
  • At least one measurable lesion per RECIST v1.1 criteria.
  • ECOG PS score: 0-1.

Exclusion criteria

  • Active or symptomatic brain metastases.
  • Previous diagnosis of any other malignancy.
  • Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion.
  • Received anti-tumor therapy 4 weeks prior to initiation of study treatment.
  • Uncontrolled tumor-related pain.
  • Subjects with severe cardiovascular and cerebrovascular diseases.

Treatment and study plan

SHR-A2102

Drug

SHR-A2102: injection, 80mg/ bottle, intravenous drip

Adebelimab (SHR-1316)

Drug

Adebelimab (SHR-1316): injection, 600mg(12mL)/ bottle, intravenous drip

SHR-8068

Drug

SHR-8068: injection, 50mg（10mL）/ bottle, intravenous drip

Primary outcomes

  1. Determination of Recommended Phase II dose (RP2D)

    Time frame: From first dose of study treatment until the end of Cycle 1（up to 21 days）

  2. Objective Response Rate (ORR)

    Time frame: From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months)

    The percentage of participants with a confirmed CR or PR according to RECIST v1.1 criteria.

  3. Incidence and severity of AEs

    Time frame: The observation period ended at the end of the 21-day period after the first dose of SHR-A2102 or Adebrelimab or SHR-8068 (up to 21 days)

Secondary outcomes

  1. Disease Control Rate (DCR)

    Time frame: From time of first dose of SHR-A2102 or Adebrelimab or SHR-8068 until the date of objective disease progression or death (up to 12 months)

    The percentage of participants who have a best objective response of confirmed CR or PR or who have SD after start of treatment.

  2. Duration of Response (DoR)

    Time frame: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months)]

    The time from the date of first response until date of disease progression or death in the absence of disease progression.

  3. Progression free Survival (PFS)

    Time frame: From time of first dose of objective disease progression until the date of objective disease progression or death (up to 12 months)

    Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death.

  4. Overall Survival (OS)

    Time frame: From time of first dose of objective disease progression until the date of death (up to 24 months)

    The time until death due to any cause.

Study contacts

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

Xin Xu

CONTACT

[email protected]

0518-82342973

Yunfei Zhang

CONTACT

[email protected]

0518-82342973

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Safety, Tolerability, and Efficacy of SHR-A2102 in Combination With Adebrelimab, With SHR-8068, in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase IB/II Open-Label, Multicenter Clinical Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Nov 12, 2024

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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