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Closed (no longer recruiting)Last updated: 28 November 2023

ADVANTIG-02: This Phase III trial is trying to understand effective different combinations of targeted and immunotherapies (Tislelizumab, Ociperlimab, and Pembrolizumab) are in people with non-small cell lung cancerA Phase 3, Randomized, Double-Blind Study of BGB-A1217, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer

Clinical summary

Summary

This is a randomised trial with three arms. In Arm A (Experimental), participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks. In Arm B (Active comparator), Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks. In Arm C (Placebo comparator), Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.

Conditions

This trial is treating patients with Non-Small Cell Lung Cancer

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

III

Trial Acronym

ADVANTIG-02

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • NCT04746924
  • BEIGENE, BGB-A317-A1217-302, TIGIT-302, CT1363, BGB-302

Trial sponsor

BeiGene Australia Pty Ltd

Scientific Title

A Phase 3, Randomized, Double-Blind Study of BGB-A1217, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer

Eligibility

Inclusion

  1. Histologically or cytologically documented locally advanced or recurrent non-small cell lung cancer (NSCLC) that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic-nonsquamous or squamous NSCLC.
  2. No prior systemic treatment for metastatic NSCLC.
  3. Agreement to provide archival tissue or fresh biopsy (if archival tissue is not available).
  4. Tumors with PD-L1 expressed in ≥ 50% tumor cells.
  5. At least 1 measurable lesion as defined per RECIST v1.1.
  6. ECOG Performance Status ≤ 1.

Exclusion

  1. Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1.
  2. Prior therapy with an anti-programmed cell death protein (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-cell immunoglobulin and ITIM (anti-TIGIT) domain, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
  3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
  4. Active autoimmune diseases or history of autoimmune diseases that may relapse.

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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