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:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT02450656
Eligibility Criteria:
Inclusion Criteria:
* Histological or cytological proof of advanced NSCLC; for PART B: treated with first line therapy for metastatic disease only.
* Written documentation of a known pathogenic KRAS (exon 2, 3 or 4) mutation and PIK3CA wildtype (defined as absence of mutations in exon 9 and 20)
* Able and willing to give written informed consent
* Able and willing to undergo blood sampling for PK and PD analysis
* Life expectancy \>=3 months allowing adequate follow up of toxicity evaluation and antitumor activity.
* WHO performance status of 0 or 1.
* Able and willing to undergo a tumor biopsies prior to start, after two weeks (part A only) and upon progression of disease
* Measurable disease according to RECIST 1.1
* Adequate organ system function measured by laboratory values
Exclusion Criteria:
* Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment.
* History of another malignancy Exception PART A: Patients who have been disease-free for at least 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent second malignancies are eligible. Exception PART B: Adequately treated carcinoma in situ of the cervix and adequately treated basal cell carcinoma of the skin. 3. Symptomatic or untreated leptomeningeal disease.
* Symptomatic brain metastasis.
* Patients previously treated with any drug combination known to interfere with EGFR, HER2, HER3, HER4 or MAPK- and PI3K-pathway components, including inhibitors of PTEN, PI3K, AKT, mTOR, BRAF, MEK and ERK.
* History of interstitial lung disease or pneumonitis
* Radio-, immuno- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment. Palliative radiation (1x 8Gy) is allowed.
* Opthalmological diseases
* Patients with left ventricular ejection fraction (LVEF) \< 55%
* Patients with cardiac comorbidities
* Concomitant or recent use (in the past 14 days) of strong inhibitors and inducers of CYP1A2, CYP2C19, CYP3A4, 3A5 and P-glycoprotein (P-gp)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02450656
Study Brief:
Protocol Section:
NCT02450656