a study on Lung Cancer
This is a Phase 2, open-label, multicenter study to assess the efficacy and safety of second/third-line treatment with nab-paclitaxel in combination with the epigenetic modifying therapy of CC-486 or immunotherapy of durvalumab, and nab-paclitaxel monotherapy in subjects with advanced non-small cell lung cancer (NSCLC).
A Phase 2, Open-Label, Multi-Center Study to Assess Safety and Efficacy of Second/Third-Line Treatment With NAB®-Paclitaxel (ABI-007) In Combination With Epigenetic Modifying Therapy Of CC-486, Or Immunotherapy of Durvalumab (MEDI4736), Or As Monotherapy In Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC): Abound.2L+
This Phase 2 study will test the hypothesis that epigenetic modifying therapy of CC-486 or immunotherapy of durvalumab can improve the anti-tumor activity of nab-paclitaxel in subjects with advanced non-small cell lung cancer (NSCLC) who have received no more than one prior chemotherapy regimen for their advanced disease. It will further assess efficacy and safety of nab-paclitaxel monotherapy in this setting. Each subject will receive study therapy as second- or third-line of treatment. Approximately 240 male and female subjects with advanced NSCLC will be assigned to one of the following treatment arms (approximately 80 subjects per group): nab-paclitaxel /CC-486 combination therapy, nab-paclitaxel/durvalumab combination therapy or nab-paclitaxel monotherapy prior to receiving first dose of Investigational Product. A permuted-block randomization method will be employed to assign the subjects among the treatment arms that are enrolling simultaneously, when applicable, stratified by the following baseline factors: ECOG performance status (0 versus 1), gender (males versus females), and smoker (yes versus no). Treatment assignments of subjects to the nab-paclitaxel/CC-486 combination therapy and nab-paclitaxel monotherapy arms will be conducted completely in a randomized fashion.
Carcinoma, Non-Small-Cell Lung Cancer of the lung lung neoplasm NSCLC - non-small cell lung cancer Nonsquamou squamous squamous NSCLC Tumor locally advanced NSCLC metastatic NSCLC advanced lung cancer metastatic lung cancer non-squamous NSCLC lung cancer Abraxane ABI-007 nab-paclitaxel albumin-bound paclitaxel taxanes CC-486 oral azacitidine azacitidine second line treatment of lung cancer second line treatment Celgene abound.2L third line treatment durvalumab immunotherapy MEDI4736 Paclitaxel Antibodies, Monoclonal
Open to people ages 18 years and up
1.Age ≥ 18 years the time of signing the Informed Consent Form (ICF).
Male subjects must:
The presence of any of the following will exclude a subject from enrollment:
The following are exceptions to this criterion:
Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication) 29. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IP.
Patients who have received prior anti-PD-1 or anti PD-L1:
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