A clinical trial to evaluate if CC-486 plus pembrolizumab works and is safe in patients with advanced or metastatic non-small cell lung cancer who have previously received platinum containing treatment.
Key facts
- Where
- Catania, OlaszországSee the site
- Phase
- 2. fázis
Where in Olaszország
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Celgene Corp.
- Trial code
- EU 2024-513405-31-00
- Record updated
- 2025. július 3.
- Original description
To estimate the efficacy of CC-486 plus pembrolizumab versus pembrolizumab plus placebo based on PFS as measured using RECIST 1.1 criteriaRead full original descriptionShow less
A Phase 2 multicenter, randomized, placebo controlled, double-blind study to assess the safety and efficacy of CC-486 (oral azacitidine) in combination with pembrolizumab (MK-3475) versus pembrolizumab plus placebo in subjects with previously treated locally advanced or metastatic non-small cell lung cancer
To estimate the efficacy of CC-486 plus pembrolizumab versus pembrolizumab plus placebo based on PFS as measured using RECIST 1.1 criteria
Inclusion: Subject is ≥ 18 years of age at the time of signing the informed consent form; Subject has histologically or cytologically confirmed squamous or nonsquamous NSCLC; Subject has stage IIIB or IV NSCLC and was pretreated with only 1 prior systemic platinum based chemotherapy; Subject has provided a formalin fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of metastatic disease has been made AND from a site not previously irradiated to assess for PD-L1 status; Subject has radiographically-documented measurable disease, as per RECIST 1.1; Subject has an ECOG performance status of 0 to 1; Subject has adequate organ and bone marrow functions.
Exclusion: Subject has received more than one line of therapy for stage IIIB or IV disease; Subject has received prior therapy with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanism; Subject has had radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting IP, and/or from whom ≥ 30% of the bone marrow was irradiated; Subject has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted; Subject with uncontrolled or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. *Subjects with controlled and asymptomatic CNS metastases may participate in this trial. The patient must have completed any prior treatment for CNS metastases (must include radiotherapy and/or surgery) >= 28 days (>= 14 days for stereotactic radiosurgery). Patients must not be receiving corticosteroids for brain metastases; Subject has active autoimmune disease that has required systemic treatment within the past 2 years; Subject with non-squamous histology has known or unknown sensitizing EGFR and/or positive ALK mutation Note: Subjects with squamous histology and unknown EGFR and ALK mutational status are eligible.