A Prospective, Randomized, Phase ll Clinical Trial of Single-agent Treatment With Different Doses of Sulfamethoxazole Furmonertinib in Patients With Advanced, Metastatic Lung Adenocarcinoma Who Have Progressed After First- or Second-line Treatment With EGFR-TKl Osimertinib

NCT06394674 Phase 2 RECRUITING

This is a prospective, randomised, uncontrolled phase II clinical trial planned to include 84 subjects with metastatic lung adenocarcinoma that had progressed after first- or second-line treatment with Osmertinib, who were randomly assigned to trial group 1 and trial group 2, and were given Furmonertinib 160 mg and 240 mg once/day, orally, respectively, with efficacy evaluated every 6 weeks until disease progression, intolerable toxic side effects, or Subjects voluntarily withdrew informed consent.

Details

Lead sponsor	Changhai Hospital
Phase	Phase 2
Status	RECRUITING
Enrolment	84
Start date	2024-05-01
Completion	2026-09

Conditions

• Non-Small Cell Lung Cancer

Interventions

• Furmonertinib

Primary outcomes

• Objective Response Rate(ORR) — Analysis will occur when PFS maturity is observed at approximately 12 months from the first patient begin study treatment
  Objective Response Rate (ORR) (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments) is defined as the number (%) of patients with response

Countries

China