BridgeMD
A trial to learn how safe newer immunotherapy drugs are and how well they work with or without other anti-cancer drugs in adults with advanced, unresectable non-small cell lung cancer
EU CTIS ID: 2025-523599-21-00
What this study is testing
To assess the safety and tolerability of immunotherapy with or without other anticancer drugs in participants with unresectable Stage III NSCLC
- 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
- 2. Histologically or cytologically documented squamous or non-squamous NSCLC.
- 3. Unresectable stage III NSCLC eligible for concurrent chemoradiation. (Stage should be determined based on IASLC v9.0 Staging Guidelines; resectability should be determined by a multidisciplinary evaluation.)
- 4. Documented absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic lymphoma kinase) rearrangements.
- 5. No known ROS1 or RET rearrangements detected as per local standard practice.
- 6. Eligible for definitive, platinum-based cCRT to a total radiation dose of 60 Gy in 30 fractions using photons.
- 7. ECOG performance status of 0 or 1.
You likely can't join if
- 1. Presence of small cell and/or neuroendocrine histology components; sarcomatoid variant; and/or other rare subtypes.
- 2. Tumor invasion of the great vessels (aorta, superior/inferior vena cava, and/or intrapericardial vessels).
- 3. Malignant pleural or pericardial effusion. Effusions must be assessed via thoracentesis or pericardiocentesis.
- 5. History of idiopathic pulmonary fibrosis, ILD, non-infectious/radiation ILD/pneumonitis that required steroids or any active signs of these conditions that cannot be ruled out by imaging at screening. Additional exclusions include organizing pneumonia or drug-induced pneumonitis/ILD.
- 7. History of organ transplant or allogeneic stem cell transplant.
- 8. History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years prior to treatment assigment and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease.
See the full eligibility criteria
- 2. Histologically or cytologically documented squamous or non-squamous NSCLC.
- 3. Unresectable stage III NSCLC eligible for concurrent chemoradiation. (Stage should be determined based on IASLC v9.0 Staging Guidelines; resectability should be determined by a multidisciplinary evaluation.)
- 4. Documented absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic lymphoma kinase) rearrangements.
- 5. No known ROS1 or RET rearrangements detected as per local standard practice.
- 6. Eligible for definitive, platinum-based cCRT to a total radiation dose of 60 Gy in 30 fractions using photons.
- 7. ECOG performance status of 0 or 1.
- 9. and 10. Known tumor PD-L1 "XXX" expression using documented local results with confirmed availablity of tumor tissue sample to confirm PD-L1 expression results.
- 11. At least one lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT (preferred) or MRI, and is suitable for accurate repeated measurements.
- 12. Adequate organ and bone marrow function.
- 1. Presence of small cell and/or neuroendocrine histology components; sarcomatoid variant; and/or other rare subtypes.
- 2. Tumor invasion of the great vessels (aorta, superior/inferior vena cava, and/or intrapericardial vessels).
- 3. Malignant pleural or pericardial effusion. Effusions must be assessed via thoracentesis or pericardiocentesis.
- 5. History of idiopathic pulmonary fibrosis, ILD, non-infectious/radiation ILD/pneumonitis that required steroids or any active signs of these conditions that cannot be ruled out by imaging at screening. Additional exclusions include organizing pneumonia or drug-induced pneumonitis/ILD.
- 7. History of organ transplant or allogeneic stem cell transplant.
- 8. History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years prior to treatment assigment and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease.
- 12. Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment.
- 13. Any prior or current systemic or radiation therapy received for NSCLC, or prior radiation therapy for any malignancy that included any lung tissue in the prior radiation fields.
- 14. Prior exposure to an anti-PD-1, anti-PD-L1, or anti-TIGIT therapy, or any other anticancer therapy targeting immune regulatory receptors or mechanisms.
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Korea, Republic of
- China
- Japan
- United States
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; Korea, Republic of; China; Japan; United States. 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.