BridgeMD
A study to compare effects and safety of CT-P51 and Keytruda in patients with previously untreated metastatic lung cancer
EU CTIS ID: 2024-514048-98-00
What this study is testing
The primary objective of this study is to demonstrate the therapeutic equivalence of CT-P51 and Keytruda in terms of ORR based on the confirmed best overall response (BOR) by the end of Cycle 11 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in the intent-to-treat(ITT) set.
- 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
- Male or female ≥ 18 years
- Stage IV, non squamous NSCLC
- Patient with negative result in both EGFR mutation and ALK rearrangement. Patients already known to have ROS1 rearrangement, MET exon 14 skipping, RET rearrangement, or BRAF V600E mutation will be excluded if ROS1, MET, RET, or BRAF-directed therapy is indicated by local guidelines
- Have a tumor sample not irradiated prior to biopsy that is adequate for PD-L1 assessment by immunohistochemistry (IHC) assay and obtained within 6 months prior to randomization
- Have not received prior systemic anticancer therapy for metastatic nsNSCLC (Prior adjuvant/neoadjuvant NSCLC therapy is permitted if completed at least 12 months prior to the development of metastatic disease.)
- Have at least 1 measurable lesion per RECIST version 1.1 (Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.) a) Tumor lesions: ≥ 10 mm in long axis by CT scan b) Malignant lymph nodes: ≥ 15 mm in short axis by CT scan
You likely can't join if
- Have predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is ineligible
- Have carcinomatous meningitis or active CNS metastases. (Note: Patients with previously treated brain metastases at least 2 weeks prior to the first study drug administration and without suspicion of further CNS progression may participate.)
- Have clinically significant third-space fluid; for example, ascites or pleural effusion that cannot be controlled by drainage or other procedures prior to the first dose
- Had prior treatment with one or more of followings: a) anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathway b) any systemic anticancer therapy for metastatic disease c) major surgery (<3 weeks prior to the first dose) d) palliative radiotherapy for non-CNS metastases (<1 week prior to the first dose) e) radiotherapy to the lung that is of > 30 Gy (<6 months prior to the first dose)
- Have known history of malignancy other than NSCLC in the past 5 years except adequately treated basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Is expected to require chronic systemic steroids
See the full eligibility criteria
- Male or female ≥ 18 years
- Stage IV, non squamous NSCLC
- Patient with negative result in both EGFR mutation and ALK rearrangement. Patients already known to have ROS1 rearrangement, MET exon 14 skipping, RET rearrangement, or BRAF V600E mutation will be excluded if ROS1, MET, RET, or BRAF-directed therapy is indicated by local guidelines
- Have a tumor sample not irradiated prior to biopsy that is adequate for PD-L1 assessment by immunohistochemistry (IHC) assay and obtained within 6 months prior to randomization
- Have not received prior systemic anticancer therapy for metastatic nsNSCLC (Prior adjuvant/neoadjuvant NSCLC therapy is permitted if completed at least 12 months prior to the development of metastatic disease.)
- Have at least 1 measurable lesion per RECIST version 1.1 (Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.) a) Tumor lesions: ≥ 10 mm in long axis by CT scan b) Malignant lymph nodes: ≥ 15 mm in short axis by CT scan
- Have a ECOG Performance score of ≤ 1, Life expectancy of at least 3 months
- Have adequate organ function
- Have predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is ineligible
- Have carcinomatous meningitis or active CNS metastases. (Note: Patients with previously treated brain metastases at least 2 weeks prior to the first study drug administration and without suspicion of further CNS progression may participate.)
- Have clinically significant third-space fluid; for example, ascites or pleural effusion that cannot be controlled by drainage or other procedures prior to the first dose
- Had prior treatment with one or more of followings: a) anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathway b) any systemic anticancer therapy for metastatic disease c) major surgery (<3 weeks prior to the first dose) d) palliative radiotherapy for non-CNS metastases (<1 week prior to the first dose) e) radiotherapy to the lung that is of > 30 Gy (<6 months prior to the first dose)
- Have known history of malignancy other than NSCLC in the past 5 years except adequately treated basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Is expected to require chronic systemic steroids
- Have an active infection requiring systemic therapy (<2 weeks prior to the first dose)
- Have interstitial lung disease or a history of pneumonitis that required steroids
- Unable or unwilling to take folic acid or vitamin B12 supplementation
The study team makes the final eligibility decision.
Where it's taking place
- Vietnam
- Argentina
- Chile
- Georgia
- Ukraine
- Bosnia and Herzegovina
- Malaysia
- Taiwan
- Mexico
- Brazil
- Serbia
- North Macedonia
- India
- Turkey
- Thailand
- Peru
- 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vietnam; Argentina; Chile; Georgia; Ukraine; Bosnia and Herzegovina 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.