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New treatment option for Lung Cancer (NSCLC)
Official title Postoperative EGFR-TKI Therapy forContralateral Pulmonary Nodules in Patients With EGFR-Mutant NSCLC（ARMOR2501）
ClinicalTrials.gov ID: NCT06924398
What this study is testing
What is Postoperative EGFR-TKI Therapy?
Postoperative EGFR-TKI Therapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for lung cancer (nsclc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background Synchronous multifocal primary lung cancer (sMPLC) presents a therapeutic challenge, particularly for bilateral lesions. While surgical resection is standard for unilateral sMPLC, bilateral surgery carries high perioperative risks.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1）Patients diagnosed with sMPLC (according to MM/ACCP clinical criteria). Preoperative chest CT (1mm slice thickness) reveals multiple bilateral...
- 2）Patients received standard anti-inflammatory treatment before surgery.
- 3）The primary lesion in the operated lung is staged as T1-2N0M0.
- 4）Patients have undergone surgical resection of one side of the lung, with pathology confirming adenocarcinoma and an EGFR-sensitive mutation (exon...
- 5）After unilateral resection, the contralateral lung must have at least one suspected malignant residual nodule [≥8mm (pure GGNs must be \>1cm) and...
You likely can't join if
- 1）Patients with lymph node metastasis or distant metastasis.
- 2）Patients with severe heart, lung, liver, or kidney dysfunction who cannot tolerate surgery.
- 3）Patients with a history of other malignancies within five years (except effectively controlled basal cell carcinoma, cervical carcinoma in situ...
- 4）Patients taking medications known to prolong the QTc interval or induce ventricular tachycardia who need to continue such medications during the...
- 5）Patients with a history of interstitial lung disease (ILD) or drug-induced ILD.
- 6）Patients with severe gastrointestinal dysfunction, diseases, or clinical symptoms that may affect drug intake, transport, or absorption.
See the full eligibility criteria
- 1）Patients diagnosed with sMPLC (according to MM/ACCP clinical criteria). Preoperative chest CT (1mm slice thickness) reveals multiple bilateral lesions, all meeting surgical criteria [≥8mm (pure ground-glass nodules...
- 2）Patients received standard anti-inflammatory treatment before surgery.
- 3）The primary lesion in the operated lung is staged as T1-2N0M0.
- 4）Patients have undergone surgical resection of one side of the lung, with pathology confirming adenocarcinoma and an EGFR-sensitive mutation (exon 19 deletion or exon 21 L858R point mutation).
- 5）After unilateral resection, the contralateral lung must have at least one suspected malignant residual nodule [≥8mm (pure GGNs must be \>1cm) and \<3cm, unchanged after standard anti-inflammatory treatment], which...
- 6）ECOG performance status (PS) score of 0-1.
- 1）Patients with lymph node metastasis or distant metastasis.
- 2）Patients with severe heart, lung, liver, or kidney dysfunction who cannot tolerate surgery.
- 3）Patients with a history of other malignancies within five years (except effectively controlled basal cell carcinoma, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and...
- 4）Patients taking medications known to prolong the QTc interval or induce ventricular tachycardia who need to continue such medications during the study period.
- 5）Patients with a history of interstitial lung disease (ILD) or drug-induced ILD.
- 6）Patients with severe gastrointestinal dysfunction, diseases, or clinical symptoms that may affect drug intake, transport, or absorption.
- 7）Patients with active hepatitis B, hepatitis C, or HIV infections.
- 8）Pregnant or lactating women or women of childbearing potential who have not taken contraceptive measures.
- 9）Patients with uncontrolled neurological or psychiatric disorders or mental illnesses.
- 10）Patients participating in other clinical trials or expected to receive other anti-tumor treatments during this trial.
- 11）Other conditions deemed unsuitable for the study by the investigators
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.