NCT04500704

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)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 166 (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 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).

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: 2021-12-01
• Completion: 2023-10-01
• First posted: 2020-08-05
• Last updated: 2020-08-05

Locations

6 sites across 1 country: China