WHO ICTRP trial
Phase 2 Study of Adagrasib Monotherapy and in Combination With Pembrolizumab and…
EUCTR2020-003101-58-HU · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2020-003101-58-HU |
|---|---|
| Public title | Phase 2 Study of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab plus Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation |
| Scientific title | A Phase 2 Trial of Adagrasib Monotherapy and in Combination with Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab plus Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation |
| Primary sponsor | Mirati Therapeutics, Inc. |
| 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): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Hungary;United States;Czechia;United Kingdom;Portugal;Spain;Canada;Austria;Netherlands;Belgium;China;Ireland;Taiwan;Korea, Republic of;Poland;Italy;Israel;Australia;Bulgaria;France;Germany |
| Conditions | Advanced Non-Small Cell Lung Cancer MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic… |
| Interventions | Trade Name: KEYTRUDA Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Pembrolizumab CAS Number: 1374853-91-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number… |
| Registration date | Feb 23, 2022 |
| Target size | 256 |
| Secondary IDs | 849-007;NCT04613596;2020-003101-58-IT |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: