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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513405-31-00

Acronym

CC-486-NSCL-001

Enrollment

Registered

2024-08-05

Start date

2015-12-10

Completion date

2025-07-07

Last updated

2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Second-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC)

Brief summary

PFS measured as time from randomization to progression according to RECIST 1.1 (based on Investigator assessment)

Detailed description

Number (%) of subj. with SD for ≥ 18 weeks, complete response (CR) or PR (DCR)., Overall survival., Number (%) of subj. who achieve an objective CR or PR (ORR)., Safety to include the incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, Grade 3-4 TEAEs, TEAEs of special interest, and laboratory abnormalities and other safety parameters., Plasma PK parameters such as maximum observed concentration (Cmax), area under the concentration-time curve (AUC), time to maximum concentration (Tmax), terminal half-life (t1/2), apparent total body clearance (CL/F) and apparent volume of distribution (Vz/F) for CC-486.

Interventions

DRUGAzacitidine 150mg tablet

DRUGAzacitidine 200mg tablet: film- coated tablet

DRUGazacitidine

DRUGPEMBROLIZUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS measured as time from randomization to progression according to RECIST 1.1 (based on Investigator assessment)	—

Secondary

Measure	Time frame
Number (%) of subj. with SD for ≥ 18 weeks, complete response (CR) or PR (DCR)., Overall survival., Number (%) of subj. who achieve an objective CR or PR (ORR)., Safety to include the incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, Grade 3-4 TEAEs, TEAEs of special interest, and laboratory abnormalities and other safety parameters., Plasma PK parameters such as maximum observed concentration (Cmax), area under the concentration-time curve (AUC), time to maximum concentration (Tmax), terminal half-life (t1/2), apparent total body clearance (CL/F) and apparent volume of distribution (Vz/F) for CC-486.	—

Measure

Time frame

—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026