Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Pemetrexed

Cisplatin

Mitogens

Aumolertinib 110 mg QD in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of every 21-day cycles up to 4\~6 cycles, followed by Aumolertinib daily with pemetrexed maintenance (500 mg/m2) on Day 1 of every 21-day cycles.

Dose may be reduced to allow for the management of investigational drug related toxicity.

Aumolertinib

Placebo Aumolertinib 110 mg QD Dose may be reduced to allow for the management of investigational drug related toxicity.

Placebo Aumolertinib

Shun Lu, MD

Zhonglin Chen, MD

Shun Lu

To assess the efficacy and safety of Aumolertinib plus chemotherapy versus Aumolertinib alone as first-line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitizing epidermal growth factor receptor mutations (EGFRm+).

HS-10296-306 is a randomized, open-label, multicenter, phase III study to assess the efficacy and safety of Aumolertinib plus chemotherapy versus Aumolertinib alone as first-line treatment in locally advanced or metastatic non-small cell lung cancer (NSCLC) with sensitizing epidermal growth factor receptor mutations (EGFRm+). Eligible patients are randomized to receive either Aumolertinib (110 mg orally, once daily) in combination with platinum-based chemotherapy (every 3 weeks for 4\~6 cycles) or Aumolertinib (110 mg orally, once daily) in a 1:1 ratio.

Aumolertinib With or Without Chemotherapy as 1st Line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Sensitizing EGFR Mutations

Efficacy and Safety of Aumolertinib With or Without Chemotherapy as First-line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Sensitizing Epidermal Growth Factor Receptor Mutations: A Randomized, Controlled, Open-label, Phase 3 and Multicenter Clinical Study

IRC-PFS is defined as the time from randomization until the date of objective disease progression based on IRC assessment or death (by any cause in the absence of progression). The patients will receive long-term follow-up including chest and abdominal CT every 6 weeks until Week 18, then every 12 weeks and onwards.

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

DoR is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.

The DCR is defined as the proportion of patients with a best overall response of CR, PR, or SD.

DepOR is defined as the sum of the lengths of the longest diameters of the RECIST 1.1 target lesions.

PFS Rate at 12, 18, 24, and 36 months is defined as proportion of progression free survival at 12, 18, 24, and 36 months from the date of randomization.

Overall survival (OS) is deﬁned as the time from randomization to death due to any cause. The survival will be followed up with telephone every 12 weeks after discontinuation of the randomized treatment.

OS rate at 3, 5 years is defined as the proportion of patients alive at 3, 5 years from the date of randomization.

AEs are graded according to CTCAE v5.0 and recorded in the case report form.

Spots Global Cancer Trial Database for placebo aumolertinib