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Thalidomide With First-line Chemotherapy and as Maintenance Treatment of Advanced Nonsquamous NSCLC
NCT03062800Phase 2
Key facts
- Status
- Unknown
- Start
- Dec 2016
- Primary completion
- Dec 2020
- Countries
- 1
- Sponsor
- Qilu Hospital of Shandong University
- Modality
- Small Molecules
- Drugs
- thalidomide
- Conditions
- Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC)
01
Overview
Phase 2, randomised trial of thalidomide in Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC) (2 arms), sponsored by Qilu Hospital of Shandong University. Primary endpoint: Progression-Free Survival at 2 years. Status: unknown.
02
Design
2 arms- Study design
- Randomized
P+Cisplatin/Carboplatin+T
Induction: Pemetrexed + Cisplatin/Carboplatin + Thalidomide. Maintenance: Thalidomide.
P+Cisplatin/Carboplatin
Induction: Pemetrexed + Cisplatin/Carboplatin. Maintenance: Pemetrexed.
03
Who it enrols
Patients aged 18-70 with stage IV non-squamous NSCLC, EGFR wild-type or unknown mutation status, ECOG PS 0-1, life expectancy >3 months, and no prior chemotherapy or radiotherapy.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Objective Response Rate
Body Weight
Vascular Endothelial Growth Factor
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