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New treatment option for Non-small Cell Lung Cancer
Official title ICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI
ClinicalTrials.gov ID: NCT06388031
What this study is testing
What is Immune checkpoint inhibitor?
Immune checkpoint inhibitor is an investigational medicine, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as Keytruda.
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
- An exploratory phase II trial of immune checkpoint inhibitors (ICIs, anti-PD-1/anti-PD-L1) as second-line treatment with advanced non-small cell lung cancer (NSCLC) who had long-term response to first-line immunotherapy (with or without chemotherapy). This study aims to evaluate efficacy and safety of ICI rechallenge in long-term responders to prior ICI.
- Phase 2: a mid-size study of how well it works
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 80
You may be able to join if
- Participants must have a thorough understanding of this study and voluntarily sign an informed consent form (ICF);
- Age between 18 and 80 years, any gender;
- Histologically or cytologically confirmed stage III-IV non-small cell lung cancer (NSCLC);
- Previous treated with first-line immunotherapy (immunotherapeutic agents include currently marketed anti-PD-L1 or anti-PD-1 monoclonal antibodies...
- Measurable disease (at least 1 lesion) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
You likely can't join if
- Received two or more prior systemic therapies;
- Known sensitive EGFR mutation (EGFR exon19 del or EGFR exon21 L858R) or ALK rearrangement;
- Symptomatic or progressing CNS metastases, leptomeningeal metastases;
- History of autoimmune disease, active autoimmune disease, immunodeficiency, or requiring systemic corticosteroid/immunosuppressive therapy; (except...
- Idiopathic pulmonary fibrosis (including interstitial pneumonia), drug-induced pneumonitis, history of (non-infectious) pneumonia/interstitial lung...
- Known active tuberculosis, human immunodeficiency virus (HIV) infection; active hepatitis B (defined as positive HBsAg or positive hepatitis B virus...
See the full eligibility criteria
- Participants must have a thorough understanding of this study and voluntarily sign an informed consent form (ICF);
- Age between 18 and 80 years, any gender;
- Histologically or cytologically confirmed stage III-IV non-small cell lung cancer (NSCLC);
- Previous treated with first-line immunotherapy (immunotherapeutic agents include currently marketed anti-PD-L1 or anti-PD-1 monoclonal antibodies: pembrolizumab, nivolumab, atezolizumab, durvalumab, tislelizumab...
- Measurable disease (at least 1 lesion) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- Adequate organ function: Hematology: Absolute neutrophil count (ANC) ≥1500/μL; Platelets ≥100000/μL; Hemoglobin ≥9.0g/dL; Renal: Serum creatinine ≤1.5×ULN or calculated creatinine clearance (CrCl) ≥60 mL/min (using...
- people must be willing and able to comply with study visits, treatment plans, laboratory tests, and other study procedures;
- Female people of childbearing potential and male people with female partners of childbearing potential must agree to use highly effective contraception during the study and for 180 days after the last dose of the study...
- Received two or more prior systemic therapies;
- Known sensitive EGFR mutation (EGFR exon19 del or EGFR exon21 L858R) or ALK rearrangement;
- Symptomatic or progressing CNS metastases, leptomeningeal metastases;
- History of autoimmune disease, active autoimmune disease, immunodeficiency, or requiring systemic corticosteroid/immunosuppressive therapy; (except: a history of hypothyroidism; well-controlled stable type I diabetes...
- Idiopathic pulmonary fibrosis (including interstitial pneumonia), drug-induced pneumonitis, history of (non-infectious) pneumonia/interstitial lung disease requiring steroid therapy;
- Known active tuberculosis, human immunodeficiency virus (HIV) infection; active hepatitis B (defined as positive HBsAg or positive hepatitis B virus DNA test result above the detection limit) or hepatitis C (defined as...
- Received systemic immunostimulatory therapy within 4 weeks before initiation of study treatment or within 5 half-lives of the drug (whichever is longer);
- Pregnancy, lactation, planning to become pregnant, or fathering a child during the anticipated duration of the study (from screening visit to 180 days after the last dose of investigational drug);
- Prior allogeneic tissue/organ transplantation and other conditions unsuitable for immunotherapy.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. 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.