Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)

What is being studied?

Conditions

Non-small Cell Lung Cancer (NSCLC), Carcinoma, Non-Small Cell Lung, Non-Small Cell Lung Carcinoma, Non Small Cell Lung Cancer, Non Small Cell Lung Carcinoma

Study type

Interventional

Purpose

Treatment

Phase

PHASE1, PHASE2

How is the study designed?

Enrollment

60 (estimated)

Group design

Sequential

Allocation

Non randomized

Masking

None

Minimum age

18 Years

Maximum age

120 Years

Eligibility sex

All

Which interventions are listed?

• Drug: azacytidine
• Drug: carboplatin
• Drug: paclitaxel
• Drug: durvalumab
• Drug: cisplatin
• Drug: gemcitabine
• Drug: pemetrexed

What will the study measure?

• Phase I: To determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of neoadjuvant aerosolized AZA in participants with operable early-stage NSCLC treated with standard of care (SOC) platinum-based chemotherapy and du... Assessment window: starts at initiation of study drug, though end of DLT period
• Phase II: To determine the frequency of pathologic complete responses (pCR) in participants receiving aerosolized AZA, durvalumab, and SOC platinum-based chemotherapy as induction therapy for early-stage NSCLC Assessment window: baseline (pre-treatment biopsy), and at the time of SOC surgery post-cycle 3

What can this record establish?

These are registered plans and status information. Enrollment marked estimated is a target, not a verified count of participants already studied. The measures listed do not establish that an intervention succeeded. Eligibility criteria and recruitment status must be checked against the full study record before considering participation.