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A study of Low-dose Decitabine plus Crizotinib in EGFR-mutation-positive advanced non-small cell lung cancer patients

Low-dose Decitabine plus Crizotinib in EGFR-mutation-positive advanced non-small cell lung cancer patients :A open-label,single-arm phase II study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-16008567
Enrollment
Unknown
Registered
2016-05-31
Start date
2016-05-31
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

non-small cell lung cancer

Interventions

experimental group:low-dose Decitabine plus Crizotinib

Sponsors

Department of Oncology, The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 72 Years

Inclusion criteria

Inclusion criteria: Histologically or cytologically confirmed advanced (stage IV) non-squamous non-small-cell lung cancer. Testing for EGFR-mutation positive (exon 19 deletion, L858R) was performed in a central laboratory by using an amplification refractory mutation system or peripheral blood circulating tumor DNA testing, Crizotinib as fristline treatment in advanced non-small cell lung cancer patients without clinically unstable central nervous system (CNS) metastasis; Aged 18-72 years; Eastern Cooperative Oncology Group (ECOG) performance status of 0-3; Expected survival period for 3 months or more; Demonstrate adequate bone marrow, liver, renal, cardiac functions; Patients without severe disease conflicting with the therapy of lung cancer; Must have signed and dated an approved Informed Consent Form.

Exclusion criteria

Exclusion criteria: Resistance to methylation drugs; Prior therapy with methylation agents or other anti-tumor treatment, except for hormone replacement therapy; EGFR-mutation negative patients; Active uncontrolled infection; Any evidence of intestinal obstruction; Patients must not be receiving any other investigational agents for 4 weeks or less. Prior treatment with Steroidal antiemetic; Psychiatric illness or social situation that would limit compliance with study requirements.

Design outcomes

Primary

MeasureTime frame
median progression-free survival;

Secondary

MeasureTime frame
median overall survival;Efficacy;Safety;

Countries

China

Contacts

Public ContactJin-an Ma

Department of Oncology, The Second Xiangya Hospital of Central South University

majinancs@aliyun.com+86 13973192715

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026