Authorised Therapeutic exploratory (Phase II) Metastatic Non-small Cell Lung Cancer

A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer.

EU CTIS ID: 2022-502738-18-00

What this study is testing

To assess the antitumor activity of tislelizumab plus investigational agent(s) with or without chemotherapy.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Histologically or cytologically confirmed NSCLC (nonsquamous or squamous) that is locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC.
  • No prior systemic treatment given as primary therapy for metastatic NSCLC. Prior adjuvant/neoadjuvant chemotherapy or definitive chemoradiation/adjuvant radiotherapy for locally advanced disease is allowed provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months before randomization/enrollment.
  • Evaluable tumor PD-L1 expression as determined by a local laboratory or by central laboratory on archival tumor tissue or fresh biopsy. Patients with unknown PD-L1 expression will not be eligible for this study.
  • At least 1 measurable lesion as defined per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • NOTE: Other protocol and sub-study protocol defined criteria may apply

You likely can't join if

  • Has mixed small cell lung cancer.
  • Patients with known EGFR mutations or actionable mutations with available targeted therapies.
  • Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-LAG-3 or any other antibody or drug targeting T-cell costimulation or immune checkpoint pathways. Note: Patients who received prior neoadjuvant, adjuvant or immuno-oncology therapies targeting PD-1 or PD-L1 in consolidation are eligible, if there has been a treatment-free interval of ≥ 6 months from last dose of immuno-oncology therapy prior to radiologic recurrence of disease.
  • Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer ≤ 14 days before randomization/enrollment.
  • Active leptomeningeal disease or uncontrolled, untreated brain metastasis, or active autoimmune diseases.
  • NOTE: Other protocol and sub-study protocol defined criteria may apply

The study team makes the final eligibility decision.

Where it's taking place

  • China
  • Georgia
  • Thailand
  • Singapore
  • Brazil
  • Malaysia
  • Canada
  • United States
  • Korea, Republic of
  • Australia
  • Moldova, Republic of

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include China; Georgia; Thailand; Singapore; Brazil; Malaysia and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.