A Phase IB/II, open label, multicenter study of INC280 administered orally in combination with gefitinib in adult patients with EGFR mutated, c-MET-amplified non-small cell lung cancer who have progressed after EGFR inhibitor treatment (CINC280X2202) - CINC280X2202

ovartis0 个研究点目标入组 8 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•* * 18 years of age.
•* Confirmed c-MET pathway dysregulation (see protocol page 35-36 for details).
•* EGFR mutated NSCLC patient who have developed acquired resistance to EGFR inhibitor treatment (see protocol page 35 for details).
•* Must have discontinued any previous anti-cancer and investigational therapy (excluding gefitinib or erlotinib) for at least 28 days before study treatment administration.
•* No more than 2 lines of chemotherapy and one line of gefitinib or erlotinib treatment.
•* Must have discontinued any previous anti-cancer antibody treatment for at least 4 weeks before study treatment administration.
•* Measurable disease as determined by RECIST version 1.1.
•* ECOG performance status *2.

•* Previous treatment with a c-MET inhibitor or HGF-targeting therapy.
•* Previous radiation therapy completed less than 4 weeks prior to dosing.
•* History of cystic fibrosis.
•* History of acute or chronic pancreatitis, surgery of pancreas or any risk factors that may increase the risk of pancreatitis.
•* Pregnancy, breast feeding.
•* Women of child-bearing potential not willing to use highly effective contraception.
•* Sexually active males must use a condom during intercourse and should not father a child in the study period.

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