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.

Phase 1

Conditions: Second-line treatment of locally advanced or metastatic non-small celllung cancer (NSCLC)
MedDRA version: 27.0Level: LLTClassification code: 10066490Term: Progression of non-small cell lung cancer Class: 10029104
MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864
MedDRA version: 21.1Level: PTClassification code: 10029522Term: Non-small cell lung cancer stage IV Class: 100000004864
MedDRA version: 21.1Level: PTClassification code: 10029521Term: Non-small cell lung cancer stage IIIB Class: 100000004864
MedDRA version: 21.1Level: PTClassification code: 10029515Term: Non-small cell lung cancer recurrent Class: 100000004864
MedDRA version: 27.0Level: PTClassification code: 10059515Term: Non-small cell lung cancer metastatic Class: 100000004864
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-513405-31-00

Lead Sponsor: Celgene Corp.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1

Inclusion Criteria

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 Criteria

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 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 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.