Chiatai Tianqing Pharmaceutical Group Co., Ltd. is conducting a randomized, controlled, double-blind, dual-simulation, multi-center, Phase III clinical study to evaluate D1553 versus docetaxel in the treatment of locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutation-positive lung cancer that has failed prior standard therapy (D1553-III-01). ". Now recruiting nationwide.

Trial Drug Profile
D-1553 tablets are a novel targeted KRAS G12C mutation inhibitor, registered and classified as a chemical drug class 1.
On December 29, 2023, China's National Drug Administration (NMPA) has accepted the New Drug Marketing Application for D-1553 Tablets for the treatment of locally advanced or metastatic non-small cell lung cancer with disease progression or intolerable disease after prior first-line systemic therapy and with the presence of KRAS G12C mutation confirmed by testing.
In August 2023, Chiatai Tianqing entered into a license and collaboration agreement with Yifang Bio to obtain the exclusive license rights for the latter's D-1553 tablets for development, registration, manufacturing and commercialization in mainland China. Meanwhile, Chiatai Tianqing will also be entitled to a certain percentage of revenue outside mainland China based on potential future data sharing cooperation.

Main Criteria for Selection
1. Voluntarily participate in this study after fully informed consent and sign a written informed consent form;
2. age ≥18 years old; male or female; ECOG score 0~1; expected survival ≥3 months;
3. pathologically confirmed locally advanced, unresectable and/or metastatic non-small cell lung cancer (AJCC 8th stage IIIb/IIIc/IV);
4. subjects must provide adequate and competent tumor tissue specimens;
5. prior disease progression or intolerable toxicity following first-line anti-PD-1/PD-L1 therapy and platinum-containing chemotherapy.

Main Exclusion Criteria
1. the subject has been treated with an anticancer agent or experimental drug within the following time windows:
(1) Has received any inhibitor targeting the KRAS G12C mutation at any time in the past;
(2) Has received docetaxel at any time in the past;
2. prior NSCLC with other driver mutations (e.g., EGFR, ALK, BRAF(V600E), HER2, MET(exon14), ROS1, RET, or NTRK1/2/3, etc.);
3. symptomatic or progressively worsening CNS metastases or carcinomatous meningitis;
4. the presence of a pre-existing history of epilepsy; the presence of superior vena cava syndrome;
5. the presence or potential for severe bone damage due to tumor bone metastases after enrollment;
6. third space effusion (including pleural effusion, abdominal effusion, or pericardial effusion) that is not well controlled clinically or requires local symptomatic management such as puncture and drainage;
7. combination of other primary malignancies, except: basal cell carcinoma of the skin or carcinoma in situ (e.g., carcinoma in situ of the skin, carcinoma in situ of the breast, carcinoma in situ of the uterine cervix) that has been in complete remission for at least 3 years prior to enrollment for other malignancies and that has been cured without treatment, and carcinoma of the prostate that requires only clinical monitoring and does not require treatment.

https://mp.weixin.qq.com/s?__biz=MzA5NDE4ODc2MA==&mid=2650366181&idx=1&sn=c2c8d3b6430ed3d19cbab717af75309d&chksm=885fa552bf282c44bb1d43ebc43e2d3d34987c567431b023c9445485921db3006dafe2140493&mpshare=1&scene=1&srcid=0425siC6IlrqWcbmBHu2T06V&sharer_shareinfo=b3d6f98a9464f4998f8582afc68823af&sharer_shareinfo_first=b3d6f98a9464f4998f8582afc68823af#rd