Ended Therapeutic confirmatory (Phase III) Patients with Locally Advanced, Unresectable Non-small Cell Lung Cancer (Stage III)

Study of durvalumab/placebo + chemoradiation therapy in Patients with Unresectable, Locally Advanced Non-small Cell Lung Cancer

EU CTIS ID: 2024-515321-29-00

What this study is testing

To assess the efficacy of durvalumab + standard of care (SoC) chemoradiation therapy (CRT) compared with placebo + SoC CRT in terms of Progression Free Survival (PFS).

  • Therapeutic confirmatory (Phase III)

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

  • '- Subjects with histologically- or cytologically-documented NSCLC - Locally advanced or unresectable (Stage III) NSCLC - World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrollment and randomization. - At least one measurable lesion, not previously irradiated - Must have a life expectancy of at least 12 weeks at randomization

You likely can't join if

  • '- Receipt of prior or current cancer treatment, including but not limited to, radiation therapy, investigational agents, chemotherapy, Durvalumab and mAbs. - Prior exposure to immune-mediated therapy, including but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti PD L2 antibodies, excluding therapeutic anticancer vaccines. - History of allogeneic organ transplantation - Active or prior documented autoimmune or inflammatory disorders - Uncontrolled intercurrent illness - History of another primary malignancy / leptomeningeal carcinomatosis / active primary immunodeficiency - Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus - Mixed small cell and NSCLC histology. - Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the local labelling - Known allergy or hypersensitivity to any of the IPs or any of the IP excipients. - Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 Gy in total (V20) of more than 35% of lung volume. - Patients who have disease considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors. Patients with T4 lesions that invade major vascular structures such as pulmonary artery or cardiac tissues are also not eligible.

The study team makes the final eligibility decision.

Where it's taking place

  • Turkey
  • Philippines
  • Brazil
  • Japan
  • Thailand
  • Korea, Republic of
  • Mexico
  • Vietnam
  • Peru
  • Russian Federation
  • India

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 Turkey; Philippines; Brazil; Japan; Thailand; Korea, Republic of 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.