BridgeMD
New treatment option for Lung Cancer Non-Small Cell Cancer (NSCLC)
Official title Immunochemotherapy, Surgery or Chemoradiation, and Durvalumab for Stage IIIA/B NSCLC
ClinicalTrials.gov ID: NCT06810609
What this study is testing
What is Immunotherapy?
Immunotherapy is an investigational medicine, being studied as a potential treatment for lung cancer non-small cell cancer (nsclc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The hypothesis of the study is that induction immunochemotherapy, followed by surgery or chemoradiation and consolidation Durvalumab immunotherapy, can significantly improve event-free survival in patients with resectable or borderline resectable NSCLC at stage IIIA/B compared to existing treatment methods.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- 1\. Patient is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed...
- IIIA: one or more lymph node levels involved at EBUS/mediastinoscopy T1/T2 N2.
- IIIB: one or more lymph node levels involved at EBUS/mediastinoscopy T3/T4 N2. 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0...
- Given technical/oncologic complete resectability (R0) at the time of randomization.
- Sufficient functional reserves for the planned surgery
You likely can't join if
- 1\. Unresectable disease. 2. Mixed histology with areas of small cell carcinoma (neuroendocrine markers). 3. ALK+/ EGFRm disease. 4. Clinically...
- Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
- All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.
- Must not have experienced a ≥ Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior...
- Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced...
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
See the full eligibility criteria
- 1\. Patient is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any...
- IIIA: one or more lymph node levels involved at EBUS/mediastinoscopy T1/T2 N2.
- IIIB: one or more lymph node levels involved at EBUS/mediastinoscopy T3/T4 N2. 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 10. Given technical/oncologic complete resectability (R0) at the...
- Given technical/oncologic complete resectability (R0) at the time of randomization.
- Sufficient functional reserves for the planned surgery
- Adequate normal organ and bone marrow function as defined before
- 1\. Unresectable disease. 2. Mixed histology with areas of small cell carcinoma (neuroendocrine markers). 3. ALK+/ EGFRm disease. 4. Clinically symptomatic vena cava superior syndrome. 5. Diffuse mediastinal...
- Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
- All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.
- Must not have experienced a ≥ Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE: Patients with endocrine AE of ≤ Grade 2 are permitted to be...
- Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance...
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 29. Current or prior use of immunostimulatory agents within 14 days before the first dose of durvalumab 30. Receipt of live...
The study team makes the final eligibility decision.
Where it's taking place
- Freiburg im Breisgau, Baden-Wurttemberg, Germany
- Stuttgart, Baden-Wurttemberg, Germany
- Giessen, Hesse, Germany
- Minden, North Rhine-Westphalia, Germany
- Bonn, Germany
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 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Freiburg im Breisgau, Baden-Wurttemberg, Germany; Stuttgart, Baden-Wurttemberg, Germany; Giessen, Hesse, Germany; Minden, North Rhine-Westphalia, Germany; Bonn, Germany. 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 ClinicalTrials.gov; the study team decides eligibility.