Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT04111458
Eligibility Criteria:
Inclusion criteria:
All parts
* Previously-identified activating Kirsten rat sarcoma viral oncogene homologue (KRAS) mutation in tumour tissue or blood prior to screening
* At least one target lesion that can be measured per Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function
* Age ≥18 years of age, or over the legal age of consent as required by local legislation.
* Signed and dated written informed consent in accordance with GCP and local legislation prior to admission to the trial.
* Women of childbearing potential who are not surgically sterilized must have a negative serum pregnancy test completed during the Screening period
* Further inclusion criteria apply
Monotherapy and combination therapy dose escalation and monotherapy dose confirmation part
\- Documented disease progression despite appropriate prior standard therapies or for whom no standard therapy exists for their tumour type and disease stage
Combination dose confirmation and expansion cohort
* Pathologically confirmed diagnosis of adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
* Locally advanced stage IIIb or metastatic stage IV Non-small cell lung cancer (NSCLC)
* Patients must have received both chemotherapy and immunotherapy
Exclusion criteria:
All parts
* Previous anticancer chemotherapy within 3 weeks of the first administration of trial drug.
* Previous treatment with RAS, Mitogen-activated protein kinase (MAPK) or Son of sevenless 1 (SOS1) targeting agents
* Major surgery performed within 4 weeks prior to start of treatment
* Uncontrolled hypertension, congestive heart failure NYHA classification of ≥3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to start of treatment
* Left ventricular ejection fraction (LVEF) \<50 %
* Congenital long QT prolongation syndrome
* Mean resting corrected QT interval (QTcF) \>470 msec
* Leptomeningeal carcinomatosis
* Presence or history of uncontrolled or symptomatic brain metastases
* Known pre-existing interstitial lung disease
* Known active hepatitis B infection (defined as presence of Hep B sAg and/or Hep B Deoxyribonucleic acid (DNA)), active hepatitis C infection (defined as presence of Hep C Ribonucleic acid (RNA))
* Active infectious disease
* Any history or presence of uncontrolled gastrointestinal disorders that could affect the intake and/or absorption of the trial drug
* History of retinal vein occlusion (RVO) or retinal pigment epithelial detachment (RPED)
* Further exclusion criteria apply
Combination part
\- Hypersensitivity to any of the excipients listed in the current Summary of Product Characteristics (SmPC)/Package insert (PI) of trametinib
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04111458
Study Brief:
Protocol Section:
NCT04111458