Clinical Trials in Italy / NCT05853575
Active, not recruiting
Phase 2
Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)
NCT05853575 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Advanced CancerMetastatic CancerMalignant Neoplasm of Lung
Study summary
This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.
Eligibility
Key Inclusion Criteria:
* Are at least 18 years old (or old enough to legally make their own treatment decisions, according to local laws).
* Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and then spread to other parts of the body) with the KRAS G12C mutation.
* Have had previous treatment with 1) chemotherapy that included a drug called cisplatin or a drug called carboplatin and 2) a type of drug called an immune checkpoint inhibitor.
* Have recovered from their prior treatment and blood tests are within a safe range.
Key Exclusion Criteria:
* Have had previous treatment with a drug that targets KRAS G12C.
* Have cancer that can potentially be removed with surgery.
* Patients with brain lesions are not eligible if 1) any untreated brain lesions are \> 2.0 cm in size 2) any brainstem lesions are present 3) ongoing steroid dosing \>10 mg daily prednisone (or equivalent) and 4) poorly controlled (\> 1/week) generalized or complex partial seizures or neurologic progression/instability due to brain lesions.
* Have certain medical conditions or need to take certain medications that, in the opinion of a trial doctor, could make it unsafe for them to participate or difficult to complete the trial assessments, or are pregnant.
Primary outcome measure(s)
- Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). — 30 months
ORR evaluation of subjects treated with adagrasib 600 mg BID without regard to food versus 400 mg BID with food having NSCLC with KRAS G12C mutation (Study Population) will be completed per blinded independent central radiology (BICR) review. Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of adagrasib until last dose of adagrasib.
Trial sites (98)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 101 | Santa Rosa | California | |
| Local Institution - 105 | Kansas City | Missouri | |
| Local Institution - 100 | Durham | North Carolina | |
| Local Institution - 106 | Dallas | Texas | |
| Local Institution - 181 | Salvador | Estado de Bahia | |
| Local Institution - 177 | Porto Alegre | Rio Grande do Sul | |
| Local Institution - 182 | Itajaí | Santa Catarina | |
| Local Institution - 178 | Belo Horizonte | São Paulo | |
| Local Institution - 102 | São Paulo | Brazil | |
| Local Institution - 175 | São Paulo | Brazil | |
| Local Institution - 527 | Zagreb | City of Zagreb | |
| Local Institution - 529 | Rijeka | Primorje-Gorski Kotar County | |
| Local Institution - 559 | Grenoble | Auvergne-Rhône-Alpes | |
| Local Institution - 556 | Pessac | Gironde | |
| Local Institution - 553 | Saint-Herblain | Loire-Atlantique | |
| Local Institution - 554 | Angers | Maine-et-Loire | |
| Local Institution - 552 | Lorient | Morbihan | |
| Local Institution - 555 | Nantes | Pays de la Loire Region | |
| Local Institution - 557 | Poitiers | Poitou-Charentes | |
| Local Institution - 561 | Nice | Provence-Alpes-Côte d'Azur Region | |
| Local Institution - 551 | Marseille | Rhône | |
| Local Institution - 560 | Villefranche-sur-Saône | Rhône | |
| Local Institution - 562 | Paris | France | |
| Local Institution - 558 | Quimper | France | |
| Local Institution - 550 | Saint-Mandé | France | |
| Local Institution - 577 | Pátrai | Achaïa | |
| Local Institution - 575 | Athens | Attica | |
| Local Institution - 580 | Thessaloniki | North Aegean | |
| Local Institution - 579 | Haidari - Athens | Pella | |
| Local Institution - 576 | Thessaloniki | Greece | |
| Local Institution - 581 | Thessaloniki | Greece | |
| Local Institution - 625 | Jerusalem | Jerusalem | |
| Local Institution - 629 | Haifa | Tel Aviv | |
| Local Institution - 628 | Tel Aviv | Tel Aviv | |
| Local Institution - 627 | Haifa | Israel | |
| Local Institution - 626 | Tel Aviv | Israel | |
| Local Institution - 778 | Pesaro | Pesaro E Urbino | |
| Local Institution - 777 | Novara | Piedmont | |
| Local Institution - 780 | Candiolo | Torino | |
| Local Institution - 779 | Milan | Italy |
+ 58 more sites — see the full list on the official registry below.
More Mirati Therapeutics Inc. trials in Italy
Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation
Active, not recruiting
A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies
Recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05853575 on ClinicalTrials.gov ↗ ← All trials in Italy