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Osimertinib Combined With Aspirin Neoadjuvant Therapy for Resectable EGFR Mutated NSCLC Patients.

ConditionsNon Small Cell Lung CancerEGFR Gene Mutation
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

About this trial

This is a single-center, prospective, single-arm, phase II study of Osimertinib combined with Aspirin neoadjuvant therapy for resectable, EGFR mutated non-small cell lung cancer (NSCLC). It is mainly aimed at the population of patients with primary IIA- IIIA EGFR sensitive mutations that are intended to be treated with Osimertinib neoadjuvant therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with resectable stage IIA-IIIA lung adenocarcinoma.

Patients with EGFR sensitizing mutations (Ex19del or L858R).

Intended neoadjuvant therapy with osimertinib, with an anticipated survival expectancy of more than 3 months.

ECOG PS 0/1.

Disqualifiers

Currently receiving other anticoagulant therapy.

Previously treated with systemic therapy for NSCLC.

Other positive driver mutations, including ALK, ROS1, MET14 exon skipping, BRAF, RET, etc.

Contraindications to the use of osimertinib and aspirin.

Trial design

Design model

Single group

Treatments tested in this trial

  • Osimertinib

    Drug

    Osimertinib is a 3rd-generation EGFR-TKI used to treat NSCLC patients with resistance to 1st generation EGFR-TKI due to T790M mutation. It has been approved in clinical applications by the FDA in 2015.

  • Aspirin

    Drug

    Aspirin, also known as acetylsalicylic acid (ASA), is a verysafe medication used to treat pain,fever, or inflammation.

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: osimertinib and aspirinExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Major pathologic response

MPR refers to the percentage of residual viable tumor cells within the tumor bed after neoadjuvant treatment, with a threshold of ≤10%, regardless of the presence of residual viable tumor cells in the lymph nodes.

Time frame
Within 1 month after surgery

Secondary outcomes

1

Disease Free Survival

DFS was defined as the time from complete surgical resection to recurrence or death due to any reason.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.
2

Objective Response Rate

Objective response rate (ORR) refers to the proportion of patients in a clinical trial or treatment setting whose tumor size reduces or disappears (partial or complete response) in response to the therapy being administered.

Time frame
1 week before surgery
3

Disease Control Rate

Disease control rate (DCR) describes the percentage of patients with advanced cancer whose therapeutic intervention has led to a complete response, partial response, or stable disease.

Time frame
1 week before surgery
4

Pathologic complete response

PCR refers to the absence of residual viable tumor cells in the tumor bed and lymph nodes after neoadjuvant therapy.

Time frame
Within 1 month after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: