Pamiparib (BGB-290) Was Used in EGFR-TkIs Resistant Non-small Cell Lung Cancer

NCT05573373 | Unknown Phase 1

• 1 other identifier: 136266
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to investigate the efficacy and safety of pamiparib in patients with EGFR-TKIs-resistant NSCLC, using a single-center, dual-arm, open-label design.

Conditions

Carcinoma, Non-Small-Cell Lung; EGF-R Positive Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Total response and partial response ratio

  8 weeks

Secondary Outcomes (6)

• Progression-free survival

  1 year

• Overall survival

  72 weeks

• Disease control rate

  an average of 1 year

• Objective response rate

  72 weeks

• Changes in tumor volume shrinking

  6 months

Study Arms (2)

Pamilarib in combination with Chemotherapy Drugs

EXPERIMENTAL

The specific chemotherapy regimen was formulated by the investigator. The dosage of chemotherapy drugs is selected according to the drug use guidelines. Combination medication, the initial dose is 40mg each time (2 capsules), 2 times a day, the total daily dose is 80mg. Can be taken with a meal or on an empty stomach. If the patient misses a dose, no additional dose should be taken, and the next prescribed dose should be taken normally at the planned time. Continue the treatment until the disease progresses or unacceptable adverse reactions occur, and the dose is adjusted.

Drug: Parimparib; Drug: Chemotherapy drug

Pamiparib in combination with Targeted Therapy Drugs

EXPERIMENTAL

The specific targeted therapy plan is formulated by the investigator. The dosage of targeted therapeutic drugs is selected according to the drug use guidelines. Combination medication, the initial dose is 40mg each time (2 capsules), 2 times a day, the total daily dose is 80mg. Can be taken with a meal or on an empty stomach. If the patient misses a dose, no additional dose should be taken, and the next prescribed dose should be taken normally at the planned time. Continue the treatment until the disease progresses or unacceptable adverse reactions occur, and the dose is adjusted.

Drug: Parimparib; Drug: Targeted Therapy Agent

Interventions

Parimparib DRUG

The dosage and protocol of the drug were carried out according to the description.

Also known as: BGB-290, Poly (ADP-ribose) polymerase (PARP) inhibitor

Pamilarib in combination with Chemotherapy Drugs; Pamiparib in combination with Targeted Therapy Drugs

Chemotherapy drug DRUG

The dosage and protocol of the drug were carried out according to the description.

Also known as: Chemotherapy Drug, Cancer

Pamilarib in combination with Chemotherapy Drugs

Targeted Therapy Agent DRUG

The dosage and protocol of the drug were carried out according to the description.

Also known as: Targeted drug

Pamiparib in combination with Targeted Therapy Drugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients: ≥18 years old
• Histologically or cytologically confirmed non-small cell lung cancer, and the disease has progressed after first-generation and/or second-generation TKIs treatment with first-line therapy and no T790 mutation, or after third-generation EGFR-TKI treatment After the disease progresses, the guidelines do not recommend a standard protocol.
• No other concurrent cancer.
• At least one previously unirradiated lesion that can be accurately measured at baseline with longest diameter ≥ 10 mm (must have a short lymph node excluding axis ≥ 15 mm) according to RECIST criteria with computed tomography (CT), magnetic resonance imaging (MRI) or clinical examination for accurate repeated measures. Or an unevaluable lesion, including but not limited to pleural and ascites, bone metastasis, etc.
• ECOG physical condition score: 0-3 points.
• Expected survival period ≥ 3 months.
• The function of major organs is good, that is, the relevant inspection indicators within 14 days before randomization meet the following requirements: a) Routine blood test:i. Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); ii. Neutrophil count \> 1.5×109/L; iii. Platelet count ≥ 90×109/L; b) Biochemical examination: i. Total bilirubin ≤ 1.5×ULN (upper limit of normal); ii. Blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) ≤ 2.5×ULN; if liver metastasis, ALT or AST ≤ 5×ULN; iii. Endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula); c) Cardiac Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ 50%.
• Sign the informed consent.
• The patient is willing and able to comply with the protocol during the study, including receiving treatment and scheduled visits and examinations, including follow-up.

You may not qualify if:

• Participated in clinical trials of other drugs within four weeks.
• Histologically or cytologically confirmed small cell, large cell neuroendocrine or carcinoid.
• There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: NYHA class 2 or higher heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention of patients.
• For female subjects: should be surgically sterilized, postmenopausal patients, or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period; Serum or urine pregnancy test must be negative within 7 days and must be non-nursing. Male subjects: Patients who should be surgically sterilized, or who agree to use a medically-approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period.
• The patient has active pulmonary tuberculosis, bacterial or fungal infection (≥ grade 2 of NCI-CTC, 3rd edition); HIV infection, HBV infection, HCV infection.
• Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders.
• The subject has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, thyroid Reduced function; subjects with vitiligo or complete remission of asthma in childhood without any intervention in adulthood can be included; subjects with asthma requiring bronchodilator medical intervention are not included).
• According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.

Sponsors & Collaborators

• Affiliated Hospital of Jiangnan University: lead

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, 214000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pamiparib; Poly A; Adenosine Diphosphate Ribose; Antineoplastic Agents

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Polyribonucleotides; Polynucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Adenosine Diphosphate Sugars; Adenosine Diphosphate; Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleoside Diphosphate Sugars; Glycosides; Carbohydrates; Ribonucleotides; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• liu quan, doctor

  Affiliated Hospital of Jiangnan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

liu quan, doctor

CONTACT

15995299079; quanliu@jiangnan.edu.cn; quanliu.lq@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 10, 2022
• Study Start: December 20, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2025
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)