NCT04500717

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

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)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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)

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Almonertinib	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.
DRUG	Almonertinib plus carboplatin and pemetrexed	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.

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-10-01
• Completion: 2023-10-01
• First posted: 2020-08-05
• Last updated: 2020-08-05

Locations

5 sites across 1 country: China