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A Study of Durvalumab Before and After Surgery for Patients with Operable Non-Small Cell Lung Cancer.
EU CTIS ID: 2023-509576-42-00
What this study is testing
To compare the efficacy of durvalumab + chemotherapy administered prior To surgery followed by durvalumab post-surgery compared with placebo + chemotherapy administered prior To surgery followed by placebo post-surgery in terms of EFS. To compare the activity of durvalumab + chemotherapy administered prior To surgery compared with placebo + chemotherapy administered prior To surgery in terms of pCR.
- 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
- Age ≥18 years.
- A pre- or post-bronchodilator FEV of 1.0 L and >40% post-operative predicted value.
- Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease.
- World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment.
- At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.
- No 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.
You likely can't join if
- History of allogeneic organ transplantation.
- Known allergy or hypersensitivity to any of the study drugs or excipients.
- Existence of more than one primary tumour such as mixed small cell and NSCLC histology.
- Patients who are candidates to undergo only pneumonectomy, segmentectomies or wedge resections.
- Patients with a documented test result confirming the presence of EGFRm or ALK translocation.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome).
See the full eligibility criteria
- Age ≥18 years.
- A pre- or post-bronchodilator FEV of 1.0 L and >40% post-operative predicted value.
- Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease.
- World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment.
- At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.
- No 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.
- Adequate organ and marrow function.
- Confirmation of a patient's tumour PD-L1 status.
- Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status.
- Planned surgery to be performed need to include lobectomy, sleeve resection or bilobectomy.
- History of allogeneic organ transplantation.
- Known allergy or hypersensitivity to any of the study drugs or excipients.
- Existence of more than one primary tumour such as mixed small cell and NSCLC histology.
- Patients who are candidates to undergo only pneumonectomy, segmentectomies or wedge resections.
- Patients with a documented test result confirming the presence of EGFRm or ALK translocation.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome).
- History of another primary malignancy.
- History of active primary immunodeficiency.
- Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus.
- Deemed unresectable NSCLC by multidisciplinary evaluation.
- Patients who have preoperative radiotherapy treatment as part of their care plan.
- Patients who have brain metastases or spinal cord compression.
- Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC.
The study team makes the final eligibility decision.
Where it's taking place
- India
- Canada
- Philippines
- Taiwan
- Russian Federation
- Vietnam
- Brazil
- Japan
- United States
- Mexico
- Argentina
- Peru
- Thailand
- Costa Rica
- China
- Chile
- Korea, 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 India; Canada; Philippines; Taiwan; Russian Federation; Vietnam and 11 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.