WHO ICTRP trial
A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or…
EUCTR2019-003372-39-CZ · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2019-003372-39-CZ |
|---|---|
| Public title | A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non–Small Cell Lung Cancer (POD1UM-304) |
| Scientific title | A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non–Small Cell Lung Cancer (POD1UM-304) |
| Primary sponsor | Incyte Corporation |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;Serbia;Philippines;Ukraine;Turkey;Russian Federation;Czech Republic;Hungary;Mexico;Argentina;Brazil;Malaysia;Poland;Romania;South Africa;Bulgaria;China |
| Conditions | Male and female participants at least 18 years of age (or as per adult age applicable per local country requirements) who have metastatic nonsquamous or squamous NSCLC. MedDRA version: 20.1 Level: LLT Classification code 10080083 Term… |
| Interventions | Product Code: INCMGA00012 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Not Available CAS Number: 2079108-44-2 Current Sponsor code: INCMGA00012 Other descriptive name: MGA012, retifanlimab Concentration unit: mg/ml… |
| Registration date | May 6, 2020 |
| Target size | 530 |
| Secondary IDs | INCMGA0012-304;NCT04205812;2019-003372-39-HU |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: