Treatment of EGFR-TKI for Residual Lesions of Multiple Synchronous Ground-glass Opacities

Sponsor
Ruijin Hospital
Study ID
NCT04982900
Phase
PHASE2
Status
Unknown

Conditions

  • Multiple Primary Lung Cancers

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • furmonertinib — DRUG
    AST2818 is an irreversible and highly selective EGFR inhibitor independently discovered and developed by Allist. It has the potential to become the best-in-class drug in the third-generation EGFR-TKIs. Data from the preclinical studies and the completed clinical studies show that AST2818 has the following advantages: 1) AST2818 has good target selectivity and tissue distribution specificity; 2) The objective response rate of AST2818 for the patients with locally advanced or metastatic NSCLC with EGFR T790M mutation is outstanding, reaching 74.1% in the key registration clinical study; 3) AST2818 has a good safety profile and is well-tolerated; 4) AST2818 and its active metabolites have a superior ability to penetrate the blood-brain barrier, and have a good therapeutic efficacy on brain metastases frequently seen in patients with NSCLC.
  • Placebo — DRUG
    The placebo has the same appearance, weight, and physical and chemical properties as the study drug, and is provided by the researcher to the subjects in control group.

Study Details

This study is a multi-center, prospective, double-blind randomized controlled clinical trial. The purpose is to evaluate the efficacy and safety of EGFR-TKI on residual GGOs after surgery in patients with multiple primary lung cancers with ground glass nodules. This study is expected to prove that compared with placebo in the control group, EGFR-TKI can significantly reduce the residual GGOs lesions in patients with EGFR-positive multiple primary lung cancers with ground-glass opacity, and bring a higher objective response rate (ORR), thus provides new insights for treatment of these patients.

Key Dates

Start date
Oct 1, 2021
Status verified
Oct 2021
Primary completion
Aug 1, 2022
Completion
Aug 1, 2022

Study Design

Enrollment
138 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EGFR-TKI Treatment Arm
    After randomization, the enrolled patients in this arm should be completely free from the risk of perioperative complications or recovered from the effects of complications, usually no earlier than 4 weeks after surgery but no more than 10 weeks after surgery, before receiving baseline follow-up and starting oral administration of Furmonertinib on the day of baseline follow-up. Patients in the treatment group should take Furmonertinib (80 mg each time) orally on an empty stomach before breakfast once a day. The medicine should be taken about the same time each day, by swallowing the whole tablet with water, without crushing or chewing. Patients should maintain oral administration of Furmonertinib for 6 consecutive months, unless there is disease progression, death, new anti-tumor therapy received or intolerance of investigational drugs.
  • Placebo Comparator: Control Arm
    After randomization, the enrolled patients in this arm should be completely free from the risk of perioperative complications or recovered from the effects of complications, usually no earlier than 4 weeks after surgery but no more than 10 weeks after surgery, before receiving baseline follow-up and starting oral administration of placebo on the day of baseline follow-up. Patients in the treatment group should take placebo (80 mg each time) orally on an empty stomach before breakfast once a day. The medicine should be taken about the same time each day, by swallowing the whole tablet with water, without crushing or chewing. Patients should maintain oral administration of placebo for 6 consecutive months, unless there is disease progression, death, new anti-tumor therapy received or intolerance of investigational drugs.

Primary Outcome Measure

Response rate of EGFR-TKI [ Time Frame: 6 months ]

Central Contacts