Status:

COMPLETED

A Study of Gimistotug (BGB-A445) in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer

Lead Sponsor:

BeiGene

Conditions:

Non-Small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The main objective of this study was to evaluate the anti-tumor activity of gimistotug (BGB-A445) plus investigational agents in participants with non-small cell lung cancer (NSCLC).

Detailed Description

This study tested whether gimistotug in combination with other agents could help treat participants with non-small cell lung cancer (NSCLC) who were already treated with other anticancer agents, inclu...

Eligibility Criteria

Inclusion

  • Advanced or metastatic NSCLC (nonsquamous or squamous) that is histologically or cytologically confirmed
  • Participants who have received no more than 2 lines of prior systemic therapies which must include anti-programmed cell death protein ligand-1 (anti-PD-(L)1) treatment and a platinum-based chemotherapy administered in combination with, or sequentially before or after the anti-PD-(L)1 treatment
  • At least 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate organ function as indicated by laboratory values during screening

Exclusion

  • With mixed small cell lung cancer
  • Has received prior therapy targeting OX40 or any other T-cell agonists
  • Has received prior therapy containing docetaxel and/or ramucirumab for advanced or metastatic NSCLC
  • Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer ≤ 14 days before the first dose of study drug(s)
  • Active leptomeningeal disease or uncontrolled and untreated brain metastasis
  • NOTE: Other criteria may apply

Key Trial Info

Start Date :

October 23 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2024

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT06029127

Start Date

October 23 2023

End Date

December 31 2024

Last Update

January 5 2026

Active Locations (18)

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Page 1 of 5 (18 locations)

1

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100021

2

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China, 400042

3

Gansu Provincial Hospital

Lanzhou, Gansu, China, 730000

4

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Guangzhou, Guangdong, China, 510405

A Study of Gimistotug (BGB-A445) in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer | DecenTrialz