Clinical trial · Interventional

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

A Phase II Study Evaluating Osimertinib Combined With Aspirin Neoadjuvant Therapy for Resectable EGFR Mutated Non-small Cell Lung Cancer (NSCLC)

NCT06018688CI-TRIAL-00069708unknownPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
EGFR Gene Mutation	—	UNRESOLVED	—
Non Small Cell Lung Cancer	Lung Non-Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Aspirin	Drug	Aspirin	ALIAS
Osimertinib	Drug	Osimertinib	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
osimertinib and aspirin
description
Osimertinib and Aspirin starting at a dose of 80 mg and 100mg once a day, orally with meals.The participants will undergo a two-month combination therapy, unless there is tumor progression (worsening) or intolerable toxic reactions that necessitate early termination of the drug treatment. Aspirin will be discontinued one week prior to the surgery.
interventionNames
1. Drug: Osimertinib
2. Drug: Aspirin

Primary outcomes (1)

measure
Major pathologic response
timeFrame
Within 1 month after surgery
description
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.

Secondary outcomes (4)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. Patients with resectable stage IIA-IIIA lung adenocarcinoma.
2. Patients with EGFR sensitizing mutations (Ex19del or L858R).
3. Intended neoadjuvant therapy with osimertinib, with an anticipated survival expectancy of more than 3 months.
4. ECOG PS 0/1.
5. Primary lesion diameter of at least 1 cm.
6. Patients who have previously taken or are currently taking aspirin therapy are allowed.

Exclusion Criteria:

1. Currently receiving other anticoagulant therapy.
2. Previously treated with systemic therapy for NSCLC.
3. Other positive driver mutations, including ALK, ROS1, MET14 exon skipping, BRAF, RET, etc.
4. Contraindications to the use of osimertinib and aspirin.

References

Publications (0)

Data not yet available

No reference posted for this study.