The "Randomized, Controlled, Double-Blind and Phase III Clinical Study of Almonertinib Mesilate VS Placebo in Maintenance Treatment of NSCLC Patients with Unresectable Locally Advanced EGFR Sensitive Mutations Without Progression After Radical Platinum-containing Chemoradiotherapy" (Clinical Study Protocol No.: HS-10296-304) 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 Academician Yu Jinming of Shandong Cancer Hospital will lead the clinical study in more than 30 hospitals nationwide.
Introduction to the study
This is a randomized, placebo-controlled, double-blind, multicenter and phase III clinical study, designed to evaluate the efficacy and safety of almonertinib mesilate (hereinafter referred to as "almonertinib") as maintenance therapy in NSCLC patients with unresectable locally advanced epidermal growth factor receptor (EGFR) sensitive mutations without progression after radical platinum-containing chemoradiotherapy (CCRT/SCRT). Target patients without progression after radical platinum-containing chemoradiotherapy will be assigned to the experimental group (almonertinib treatment group) or the control group (placebo group) at a ratio of 2:1 within 6 weeks (1-42 days, inclusive) after the end of chemoradiotherapy, and will be treated with oral almonertinib or placebo once a day until disease progression as assessed by imaging or other criteria for termination of treatment were met. Relevant tests and almonertinib mesilate tablets during the study will be provided for free.
Eligibility criteria
1. Patients with histologically or cytologically confirmed locally advanced (stage III), unresectable NSCLC (according to the 8th edition lung cancer staging criteria of AJCC);
2. Male or female aged 18 or above;
3. Confirmed as EGFR sensitive mutation (including exon 19 deletion or L858R mutation, existing alone or coexisting with mutations in other EGFR loci, and patients with positive T790M mutation can be enrolled);
4. No disease progression during or after radical platinum-containing chemoradiotherapy;
5. Patients must receive concurrent chemoradiotherapy or sequential chemoradiotherapy as defined below:
1) Patients with concurrent chemoradiotherapy (CCRT) must receive at least 2 cycles of platinum-containing regimen or 5 doses of platinum-based chemotherapy (once a week), and must be randomized within 6 weeks (1-42 days, inclusive) after CCRT. Chemotherapy within one week before radiotherapy is classified as concurrent chemotherapy, and the final chemotherapy cycle must end before or concurrently with the last radiation dose (a final cycle of dual platinum and pemetrexed therapy is allowed within 3 days after the last radiation dose). Consolidation chemotherapy after radiotherapy is not allowed, but ≤2 cycles of platinum-containing regimen induction chemotherapy prior to CCRT is allowed.
2) Sequential chemoradiotherapy (SCRT) is defined as chemotherapy and subsequent radiotherapy, rather than radiotherapy and subsequent chemotherapy. Patients with SCRT must receive at least 2 cycles of platinum-containing chemotherapy prior to radiotherapy and be randomized within 6 weeks (1-42 days, inclusive) after the last radiation dose. Consolidation chemotherapy after radiotherapy is not allowed.
3) If a patient receives at least 2 cycles of platinum-containing chemotherapy, followed by 1 cycle of platinum-containing chemotherapy or <5 doses of platinum-containing chemotherapy (once a week) combined with concurrent radiotherapy, this treatment modality is defined as SCRT. If a patient receives 1 cycle of platinum-containing chemotherapy, followed by 1 cycle of platinum-containing chemotherapy or <5 doses of platinum-containing chemotherapy (once a week) combined with concurrent radiotherapy, this treatment modality is neither CCRT nor SCRT, and the patient does not meet the inclusion criteria.
6. Patients who have not received any prior antitumor therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, biologic therapy, or targeted therapy, except for radical chemoradiotherapy for stage III disease);
7. No history of interstitial lung disease (ILD) prior to CCRT;
8. No serious gastrointestinal dysfunction.
Contact information
If you are interested in participating in the study, please contact one of the persons below, who will introduce the study face to face in more detail and arrange for you to be examined accordingly. If you meet the requirements, you will receive drug treatment and post-treatment follow-up observations.
Meng Xiangjiao, Director 13793150996
Zhao Hong, Physician 15269198816
Yan Xing, Teacher 15612420171
