A clinical trial to evaluate if CC-486 plus pembrolizumab works and is safein patients with advanced or metastatic non-small cell lung cancer whohave previously received platinum containing treatment.
- Conditions
- Second-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC).MedDRA version: 21.1Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-005614-29-IT
- Lead Sponsor
- CELGENE CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 90
-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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
-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.
-Subject has received more than one line of therapy for stage IIIB or IV disease
-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 has active autoimmune disease that has required systemic treatment within the past 2 years
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To estimate the efficacy of CC-486 plus pembrolizumab versus pembrolizumab plus placebo based on PFS as measured using RECIST 1.1 criteria;Secondary Objective: ¿To estimate DCR of CC-486 plus pembrolizumab versus pembrolizumab plus placebo<br>¿To estimate OS of CC-486 plus pembrolizumab versus pembrolizumab plus placebo<br>¿To estimate ORR of CC-486 plus pembrolizumab versus pembrolizumab plus placebo<br>¿To evaluate safety and tolerability of CC-486 plus pembrolizumab versus pembrolizumab plus placebo<br>¿To evaluate the impact of pembrolizumab on the pharmacokinetics of CC-486;Primary end point(s): PFS measured as time from randomization to progression according to<br>RECIST 1.1 (based on Investigator assessment);Timepoint(s) of evaluation of this end point: Dopo l’osservazione di 70 eventi di PFS
- Secondary Outcome Measures
Name Time Method