Phase I/II study with the combination of dacomitinib and PD-0325901 in metastatic KRAS mutation positive non-small cell lung cancer - Phase I/II study with dacomitinib + PD-0325901 in KRASm NSCLC

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 132 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1. Histological or cytological proof of metastatic NSCLC
•2. Written documentation of a known pathogenic KRAS (exon 2, 3 or 4) mutation and PIK3CA wildtype (exon 9 and 20).
•3. Age ><= 18 years.
•4. Able and willing to give written informed consent.
•5. WHO performance status of 0 or 1.
•6. Able and willing to undergo blood sampling for PK and PD analysis.
•7. Able and willing to undergo tumor biopsies prior to start, while on study treatment and upon progression of disease
•8. All toxicities related to prior treatment should have resolved to CTCAE grade 1 or less (excluding alopecia)
•9. Life expectancy ><= 3 months allowing adequate follow up of toxicity evaluation and antitumor activity.
•10. Measurable disease according to RECIST 1.1 criteria
•11. Adequate organ system function

•1. Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment.
•2. History of additional prior malignancies.
•3. Symptomatic or untreated leptomeningeal disease.
•4. Symptomatic brain metastasis.
•5. Patients previously treated with any targeted drug combination known to interfere with EGFR, HER-2, HER-3, HER-4 or MAPK- and PI3K-pathway components, including inhibitors of PTEN, PI3K, AKT, mTOR, BRAF, MEK and ERK.
•6. History of interstitial lung disease or pneumonitis
•7. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral dacomitinib/PD-0325901 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
•8. Woman who are pregnant or breast feeding.
•9. Unreliable contraceptive methods.
•10. Radio-, immuno- or chemotherapy within the last 4 weeks prior to receiving the first dose of investigational treatment. Palliative radiation (1x 8Gy) is allowed.
•11. Patients who have undergone any major surgery within the last 2 weeks prior to starting study drug or who would not have fully recovered from previous surgery.
•12. Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients.
•13. Patients with a known history of hepatitis B or C.

发起方

Antoni van Leeuwenhoek Ziekenhuis