AZD9291联合用药的非小细胞肺癌1期临床实验

正在临床实验联合疗法的药品组合，至少是正在在人身上试的，
一般来说单独的药也已经做过一期实验了，安全性不会特别差，
可以用来作为AZD9291耐药后治疗方案的参考

https://clinicaltrials.gov/ct2/s ... =azd9291&rank=1

EGFR突变并且对EGFR 抑制剂耐药之后的NSCLC

一期临床实验（一般组合用药属于Ib）
开始日期 2014年8月
预计结束日期 2017年6月

有三组，AZD9291分别联合 MEDI4736, AZD6094 or selumetinib
观察EGFR TKI 耐药后，使用上述药物组合安全性/副作用， 耐受性

标题
Brief Title  AZD9291 in Combination With Ascending Doses of Novel Therapeutics

Official Title ：　A Multi-arm, Phase Ib, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9291 in Combination With Ascending Doses of Novel Therapeutics in Patients With EGFRm+ Advanced NSCLC Who Have Progressed Following Therapy With an EGFR TKI

摘要
Brief Summary ：The purpose of this study is to determine the safety, tolerability and preliminary anti-tumour activity of AZD9291 when given together with one of either MEDI4736, AZD6094 OR selumetinib in patients with EGFR mutation positive advanced lung cancer.

描述
Detailed Description ：A Phase Ib, Open-Label, Multiarm, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9291 in Combination with Ascending Doses of Novel Therapeutics in Patients with EGFRm+ Advanced NSCLC who have progressed following therapy with an EGFR TKI

Sponsor: AstraZeneca  阿斯利康

Intervention  不同的分组

（１）　•Drug: AZD9291 in combination with MEDI4736
AZD9291 and MEDI4736 will be administered. Part A: If initial dosing is tolerated then subsequent cohorts will test increasing doses of AZD9291 and/or MEDI4736, until a recommended dose for further clinical evaluation is defined. Part B: The recommended dose from Part A will be further evaluated in an expansion cohort.

（２） •Drug: AZD9291 in combination with AZD6094 （Volitinib）
AZD9291 and AZD6094 will be administered in combination. Part A: If tolerated, subsequent cohorts will test increasing doses of AZD9291 and/or AZD6094, until a recommended dose for further clinical evaluation is defined. Part B: The recommended dose from Part A will be further evaluated in an expansion cohort.

（３）•Drug: AZD9291 in combinatin with selumetinib （ARRY 142886）持续用药
AZD9291 and selumetinib will be administered in combination. Part A: If tolerated, subsequent cohorts will test increasing doses of AZD9291 and/or selumetinib, until a recommended dose for further clinical evaluation is defined. Part B: The recommended dose from Part A may be further evaluated in an expansion cohort.

（４） •Drug: AZD9291 in combination with selumetinib （ARRY 142886）间歇用药
AZD9291 will be administered with intermittent doses of selumetinib. Part A: If tolerated, subsequent cohorts will test increasing doses of AZD9291 and/or selumetinib, until a recommended dose for further clinical evaluation is defined. Part B: The recommended dose from Part A may be further evaluated in an expansion cohort.


Current Primary Outcome

•Number of participants with Adverse Evants and/or Dose Limiting Toxicities as a Measure of Safety and tolerability of AZD9291 when given in combination with MEDI4736, AZD6094 or selumetinib [ Time Frame: Adverse events will be collected from baseline until 28 days after the last dose in the AZD6094 or selumetinib arms and until 90 days after the last dose in the MEDI4736 arm, expected average 7.5 months ] [ Designated as safety issue: Yes ]
Part A: To investigate the safety and tolerability of AZD9291 when given orally to patients with EGFRm+ NSCLC in combination with MEDI4736, AZD6094 or selumetinib who have progressed following prior therapy with an EGFR TKI agent, and define the combination dose(s) for further clinical evaluation.

•Number of participants with Adverse Events as a measure of safety and tolerability and progression free survival as a measure of efficacy of AZD9291 when given in combination with AZD6094 or selumetinib [ Time Frame: Adverse events will be collected from baseline until 28 days after the last dose, expected average 7.5 months ] [ Designated as safety issue: Yes ]
Part B: To investigate the safety, tolerability and efficacy (objective response rate) of AZD9291 when given in combination with AZD6094 or selumetinib in patients with locally advanced or metastatic NSCLC, who have progressed on a T790M directed EGFR TKI.

对的，副作用很可能 1+1>2
自己试药要严密监测安全性和副作用，出现副作用要及时停药或者减量

有点遥远， 而且要知道联合用药的剂量，  我们也好有点方向