NCT04841811

MRD Guiding Treatment After Almonertinib Induction Therapy for EGFRm+ Stage III NSCLC in the MDT Diagnostic Model.

Effectiveness and Safety of Dynamic MRD Guiding Treatment After Aumolertinib Induction Therapy of EGFR-mutation-positive Unresectable Stage III Non-Small Cell Lung Cancer in the MDT Diagnostic Model: an Open-label, Multicenter, Randomized, Phase III Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Guangdong Association of Clinical Trials · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-center, randomized, phase III study. It is aimed to firstly evaluate the effectiveness and safety of almonertinib induction therapy in EGFR-mutated patients with unresectable stage III non-small cell lung cancer, and to evaluate the effectiveness and safety of dynamic MRD guided maintenance therapy with almonertinib after induction therapy with almonertinib and local therapy (radical surgery or radiotherapy) evaluated by MDT diagnostic model. The study includes a screening period (not more than 28 days after the subject with signed informed consent before first medication), treatment period (including induction therapy with almonertinib\\ radical therapy under MDT model\\ consolidation therapy with almonertinib) and follow-up period.

Detailed description

This is an open-label, multi-center, randomized, phase III study. It is aimed to firstly evaluate the effectiveness and safety of almonertinib induction therapy in EGFR-mutated patients with unresectable stage III non-small cell lung cancer, and to evaluate the effectiveness and safety of dynamic MRD guided maintenance therapy with almonertinib after induction therapy with almonertinib and local therapy (radical surgery or radiotherapy) evaluated by MDT diagnostic model. The study includes a screening period (not more than 28 days after the subject with signed informed consent before first medication), treatment period (including induction therapy with almonertinib\\ radical therapy under MDT model\\ consolidation therapy with almonertinib) and follow-up period. Eligible subjects receive 110 mg of almonertinib once a day for 8 consecutive weeks of induction therapy; local treatment (surgical or radical radiotherapy) is selected after MDT assessment. Subjects will be randomly assigned to groups A and B. Stratification factors included EGFR 19deletion or EGFR 21L858R mutation; shedding or non-shedding ctDNA at baseline; radical surgery or radiotherapy under MDT model. Subjects in group A will receive 110 mg of almonertinib once a day for 2 years. Imaging evaluation is conducted every 12 weeks. Subjects in group B will receive almonertinib guided by dynamic MRD monitoring. When ctDNA was positive (MRD+), subjects will receive 110 mg of almonertinib once a day for 12 weeks; when ctDNA was negative (MRD-), subjects will stop almonertinib and be observed for 12 weeks. This model will continue until disease recurrence or metastasis.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Almonertinib	ctDNA dynamic monitoring guided the Almonertinib treatment group after redical surgery orradiotherapy

Timeline

• Start date: 2022-06-20
• Primary completion: 2024-12-31
• Completion: 2026-12-31
• First posted: 2021-04-12
• Last updated: 2023-11-18

Locations

1 site across 1 country: China