Phase II Study of AZD9291 in patients with advanced stage non-small cell lung cancer following prior EGFR TKI Therapy with EGFR and T790M mutations detected in plasma circulating tumor DNA (PLASMA)

ational University Cancer Institute0 sites108 target enrollmentTBD

ConditionsNeoplasms

Overview

Phase: 未知
Intervention: Not specified
Conditions: Neoplasms
Sponsor: ational University Cancer Institute
Enrollment: 108
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

September 20, 2023

Last Updated

2 years ago

Study Type

Interventional Study

Sex

All

Investigators

Sponsor

ational University Cancer Institute

Eligibility Criteria

Inclusion Criteria

•1\. Provision of informed consent prior to any study specific procedures
•2\. Patients must be \> 21 years of age.
•3\. Locally advanced/metastatic NSCLC not amenable to curative surgery or radiotherapy
•4\. Documentation of activating EGFR mutations (exon 19 deletions or exon 21 L858R substitution mutations) at the time of initial diagnosis
•5\. Radiological documentation of disease progression: following 1st line EGFR TKI treatment but who have not received further treatment OR following prior therapy with an EGFR TKI and a platinum\-based doublet chemotherapy. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study. Maintenance therapy given after first line chemotherapy will be considered as part of the first line if given to patients with documented response or stable disease before starting the maintenance therapy. Neo\-adjuvant and adjuvant systematic therapies will count as one prior line of treatment if relapse occurred within 12 months form the end of the neo\-adjuvant or adjuvant systemic therapy.
•6\. Patient may receive up to two lines of therapies (including EGFR TKI).
•7\. Patient is eligible even if he/she had 2 prior EGFR TKIs if the switch was because of toxicity issue and not because of disease progression.
•8\. Plasma sample must harbour an EGFR mutation known to be associated with EGFR TKI sensitivity (exon 19 deletion, L858R). Confirmation of T790M status by central
•lab testing from a plasma sample taken after confirmation of disease progression on the most recent treatment regimen.
•9\. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:

Exclusion Criteria

•1\. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
•2\. Treatment with an EGFR\-TKI within 8 days of start of treatment; any cytotoxic chemotherapy, or other anticancer drugs within 21 days of start of treatment
•3\. Treatment with an investigational drug within five half\-lives of the compound
•4\. Prior treatment with an immune checkpoint inhibitor
•5\. Previous treatment with AZD9291 (or 3rd generation EGFR TKIs)
•6\. Patients with second primary cancer, except: adequately treated non\-melanoma skin cancer, curatively treated in\-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for \= 3 years
•7\. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks
•8\. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum\-therapy related neuropathy.
•9\. Unstable spinal cord compression/brain metastases unless asymptomatic, stable and not requiring steroids for at least 2 weeks prior to start of study treatment.
•10\. Major surgery within 4 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.