WHO ICTRP trial
Study of durvalumab or placebo administered with radiation therapy for patients…
EUCTR2018-002572-41-PL · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2018-002572-41-PL |
|---|---|
| Public title | Study of durvalumab or placebo administered with radiation therapy for patients with early stage non-small cell lung cancer |
| Scientific title | A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab with Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515)… |
| Primary sponsor | AstraZeneca AB |
| 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 | Russian Federation;United States;Japan;United Kingdom;Spain;Canada;Netherlands;Belgium;China;Poland;Korea, Republic of;Italy;Israel;France;Türkiye;Germany |
| Conditions | Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer MedDRA version: 21.1 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 10029104 - Neoplasms benign, malignant… |
| Interventions | Product Name: durvalumab Product Code: MEDI4736 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Durvalumab CAS Number: 1428935-60-7 Current Sponsor code: MEDI4736 Other descriptive name: MEDI4736… |
| Registration date | Dec 18, 2018 |
| Target size | 690 |
| Secondary IDs | D9103C00001 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
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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: