A Single-arm, Open-label, Multicenter Phase II Clinical Study of Neratinib Tablets in the Treatment of Advanced NSCLC With Rare EGFR Mutations

Convalife (Shanghai) Co., Ltd.1 site in 1 country42 target enrollmentNovember 20, 2023

ConditionsNSCLC

InterventionsNeratinib tablets

DrugsNeratinib tablets

Overview

Phase: Phase 2
Intervention: Neratinib tablets
Conditions: NSCLC
Sponsor: Convalife (Shanghai) Co., Ltd.
Enrollment: 42
Locations: 1
Primary Endpoint: IRC-assessed objective response rate (ORR)
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Single-arm, open-label, multicenter phase II clinical study

Detailed Description

Fourteen patients each had three mutation sites and 42 patients were co-enrolled，To evaluate the objective response rate (ORR) of neratinib Tablets in advanced NSCLC with rare EGFR mutations (including G719X, E709X in exon 18, S768I in exon 20 and L861Q in exon 21).

Registry

clinicaltrials.gov

Start Date

November 20, 2023

End Date

December 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Convalife (Shanghai) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years;
•Histologically or cytologically confirmed non-small cell lung cancer, stage IIIB or IV according to IASLC 2009;
•Tissue or blood samples are confirmed by the central laboratory or research center as rare EGFR mutations, including exon 18 G719X, E709X, etc., S768I in exon 20 and at least one of the L861Q mutations in exon 21;
•Ineffective or intolerant to standard treatment regimens, and disease progression after treatment;
•The number of previous chemotherapy regimens does not exceed 2 (a. replacement of platinum drugs for drug toxicity reasons is counted as a regimen; b. postoperative adjuvant chemotherapy, from the end of treatment to recurrence \> 6 months is not counted as a previous chemotherapy regimen);
•ECOG standard score 0-1;
•Predicted survival ≥ 12 weeks;
•Presence of measurable lesions according to RECIST 1.1: At least one lesion that is not irradiated, ≥ 10 mm in long diameter (lymph node lesions need to be ≥ 15 mm in short diameter), and can be accurately measured at baseline and can be repeatedly measured under CT or MRI; If the subject only has post-radiotherapy lesion, and this lesion has been confirmed as imaging progression and can be measured, it can be selected as target lesion (except for brain lesion), and brain lesion is not included as measurable target lesion;
•Subjects with asymptomatic brain metastases or brain metastases can be included in this study when the following conditions are met: brain metastases are treated and stable, such as clinical examination and brain scan (MRI or CT scan) confirmed at least 4 no evidence of lesion progression during the screening period, no neurological symptoms and no need for corticosteroid therapy. If the subject has brain metastases that have been treated surgically or with radiation, a time window of ≥ 4 weeks is required before the first dose of nelatidine tablets to ensure that adverse events associated with radiation or surgical treatment have decreased to ≤ Grade 1;
•Bone marrow reserve or organ function needs to meet the following laboratory value criteria:

Exclusion Criteria

•Received any of the following treatments:
•previous treatment with any EGFR tyrosine kinase inhibitor;
•major surgery 4 times before the first dose of the study drug; c. 4 times before the first dose of the study drug, more than 30% of bone marrow irradiation, or extensive radiotherapy; d. within 7 days before the first dose of the study drug, the use of CYP3A4 strong inhibitors, inducers or drugs that are CYP3A4 sensitive substrates with a narrow therapeutic window;
•Patients with other malignant tumors and need standard treatment or major surgery within 2 years after the first dose of study treatment;
•In the beginning of the study treatment, there are greater than CTCAE grade 1 failed to alleviate the residual toxicity of previous treatment, except alopecia and previous chemotherapy-induced grade 2 neurotoxicity;
•Spinal cord compression or brain metastasis, unless asymptomatic, stable condition, and not requiring steroid therapy for at least 2 weeks before the first dose of study treatment;
•Poor blood pressure control after drug treatment (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg);
•Patients with severe or uncontrollable systemic diseases, including gastrointestinal ulcers and bleeding and other diseases;
•There are many factors that affect the oral administration of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction and other gastrointestinal diseases or abnormalities);
•12 ECG: QTcF: female \> 470 ms, male \> 450 ms;