"Efficacy and Safety of Almonertinib Mesilate VS Platinum-Containing Dual-Agent Chemotherapy in First-line Treatment of Locally Advanced or Metastatic NSCLC with EGFR Non-Classical Mutations: A Randomized, Controlled, Open, Phase III, Multicenter Clinical Study" (Clinical Study Protocol No.: HS-10296-305) initiated by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. has been approved by the National Medical Products Administration and the ethics committee of the study leader, and Professor Zhang Li of Sun Yat-sen University Cancer Center will lead the clinical study in a number of hospitals across China.
Introduction to the study
This is a randomized, controlled, open, Phase III, multicenter clinical study to evaluate the efficacy and safety of almonertinib mesilate ("almonertinib") VS platinum-containing dual-agent chemotherapy as first-line therapy for locally advanced or metastatic NSCLC with EGFR non-classical mutations in patients. Relevant examination and test drugs arising from clinical trials will be provided free of charge, and subjects will also receive a certain amount of transportation allowance.
Eligibility criteria
1. Aged 18 years old or above.
2. Cytologically or histologically confirmed primary NSCLC; non-squamous cell carcinoma in histology.
3. Tumor stage: locally advanced or metastatic NSCLC (including patients with recurrence after previous surgical treatment or initial diagnosis of stage IIIB, IIIC or IV). In the case of recurrence after previous surgical treatment, the period from the end of surgery or adjuvant therapy (whichever is later) to recurrence shall be equal to or greater than six months. In the case of stage III patients, radical surgery shall be non-applicable to them, and they refuse or are not in the proper condition to receive the current standard treatment (e.g. radical chemoradiotherapy).
4. No previous systematic treatment for locally advanced or metastatic NSCLC. For patients who have received local treatment, if the lesions within the scope of local treatment are non-target lesions or have progressed after local treatment (except chest radiotherapy or pneumonectomy for lung cancer), they can be enrolled in the study.
5. Tumor tissues or blood samples after diagnosis of locally advanced or metastatic NSCLC are confirmed as EGFR non-classical mutations (one or more of L861Q, G719X or S768I mutations, including coexisting exon 19 deletion, L858R mutation or T790M mutation, and excluding exon 20 insertion mutation) by central laboratory testing using Xiamen AmoyDx EGFR mutation detection kit.
6. According to RECIST1.1, the patient has at least one target lesion. The requirements for target lesions are: measurable lesions that have not undergone local treatment such as irradiation or have definitely progressed after local treatment, with the longest diameter ≥ 10 mm at baseline (in the case of lymph nodes, the maximum short diameter ≥ 15 mm).
7. The Eastern Cooperative Oncology Group (ECOG) physical status (PS) score is 0 or 1, without deterioration in the two weeks prior to randomization, and with a minimum expected survival of >12 weeks.
Contact information
If you are interested in participating in the study, please contact the study physician below. He will introduce the study face to face in more detail and arrange for you to be examined accordingly. If you meet the criteria, you will receive drug treatment and post-treatment follow-up observations.
Contact person: Physician Fang Wenfeng
Mobile: 15322302066
Address: 651 Dongfeng East Road, Yuexiu District, Guangzhou (Sun Yat-sen University Cancer Center, Yuexiu); S378 (Jiulong Avenue), Huangpu District, Guangzhou (Sun Yat-sen University Cancer Center, Huangpu)
