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Almonertinib 110mg PO once daily in combination with pemetrexed (500 mg/m2) plus carboplatin (AUC=5) on Day 1 of 21day cycles (every 3 weeks) for 4-6 cycles, followed by Almonertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.

Almonertinib 110mg PO once daily. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

Almonertinib

Almonertinib plus carboplatin and pemetrexed

Jie Wang

Jun Zhao

Zhe Liu

Chuanhao Tang

Ping Wang

Dingzhi Huang

This is a multicenter, randomized, controlled, phase III study.

Almonertinib Alone Versus Almonertinib Plus Chemotherapy as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation Positive With Concomitant Non-EGFR Driver Gene Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Multicenter, Open-label, Randomized, Control Phase III Study (ACROSS 1).

Almonertinib Plus Chemotherapy as First-line Treatment in Patients With EGFR Concomitant Non-EGFR Driver Gene Mutant, Locally Advanced or Metastatic NSCLC

Almonertinib Alone Versus Almonertinib Plus Chemotherapy as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation Positive With Concomitant Non-EGFR Driver Gene Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Multicenter, Open-label, Randomized, Control Phase III Study (ACROSS 1)

To assess the efficacy of Almonertinib compared with Almonertinib Plus carboplatin and pemetrexed as first line therapy to EGFRm+, locally advanced or metastatic NSCLC patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

ORR is defined as the percentage of patients who have at least 1 response of CR or PR prior to any evidence of progression assessed up to 24 months

Number of adverse events (AEs)/serious adverse events (SAEs)

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Almonertinib Alone Versus Almonertinib Plus Chemotherapy as First-Line Treatment in Locally Advanced Or Metastatic NSCLC Patients With Concomitant EGFR and Tumor Suppressor Gene Mutation: A Multicenter, Open-Label, Randomized, Controlled Phase III Study (ACROSS2)

Almonertinib Plus Chemotherapy as First-line Treatment in Patients With EGFR Concomitant Tumor Suppressor Gene Mutation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Almonertinib Plus Chemotherapy as First-line Treatment in Patients With EGFR Concomitant Non-EGFR Driver Gene Mutant, Locally Advanced or Metastatic NSCLC	NCT04500704	Non Small Cell ...	Almonertinib Almonertinib pl...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Almonertinib Plus Chemotherapy as First-line Treatment in Patients With EGFR Concomitant Non-EGFR Driver Gene Mutant, Locally Advanced or Metastatic NSCLC	NCT04500704	Non Small Cell ...	Almonertinib Almonertinib pl...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Almonertinib Plus Chemotherapy as First-line Treatment in Patients With EGFR Concomitant Tumor Suppressor Gene Mutation	NCT04500717	Non Small Cell ...	Almonertinib Almonertinib pl...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Spots Global Cancer Trial Database for almonertinib plus carboplatin and pemetrexed