Efficacy of Targeted Therapy Combined Chemotherapy in Advanced EGFR Positive NSCLC Patients

NCT04552613 | Completed DMC

• 1 other identifier: K2020109
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, multicenter clinical study ，which is designed to compare the efficacy of the safety and efficacy of treatment every 6 weeks in EGFR positive (Non-small cell lung cancer, NSCLC) with concurrent Driver gene mutations，who used EGFR-TKI with or without combined chemotherapy，estimated with stable efficacy (CR, PR, and SD) .In this study, subjects will be randomly assigned to the following two groups according to a 1:1 ratio:(A) Standard programme group, EGFR-TKI targeted therapy; (B) controlled programme group, EGFR-TKI targeted therapy combined chemotherapy(pemetrexed plus carboplatin for 4 cycles )

Conditions

Non-small-lung-cell Cancer; NSCLC; EGFR Gene Mutation

Outcome Measures

Primary Outcomes (2)

• progression-free survival

  Patients with oncological diseases have a period of time from the start of treatment to the observation of disease progression or death due to any cause

  three years

• objective response rate

  Refers to the proportion of patients whose tumor shrinkage reaches a certain amount and remains for a certain period of time, including CR + PR cases

  three years

Secondary Outcomes (1)

• overall survival

  three years

Study Arms (2)

Standard programme group

EXPERIMENTAL

EGFR-TKI targeted therapy

Drug: EGFR-TKI

controlled programme group

ACTIVE COMPARATOR

EGFR-TKI targeted therapy combined chemotherapy(pemetrexed plus carboplatin for 4 cycles )

Drug: EGFR-TKI combined with chemotherapy (pemetrexed plus carboplatin)

Interventions

EGFR-TKI DRUG

(A) Standard programme group, EGFR-TKI targeted therapy;

Standard programme group

EGFR-TKI combined with chemotherapy (pemetrexed plus carboplatin) DRUG

(B) controlled programme group, EGFR-TKI targeted therapy combined chemotherapy(pemetrexed plus carboplatin for 4 cycles )

controlled programme group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer for clinical research, fully understand, inform and sign informed consent forms (Informed Consent Form, ICF), willing to follow and be able to complete all trial procedures.
• to 80 years old (with critical values) when signing ICF.
• Histopathology or hemology diagnostics of phase IIIB or IV (AJCC Version 8) NSCLC that cannot be surgicalor-able or radiotherapy.
• Patients have never received systemic treatment throughout the body for phase IIIB or IV NSCLC(Neoadjuvant or adjuvant chemotherapy is excluded).
• Known EGFR sensitivity mutations with concurrent other Driver gene mutations, such as T790M，TP53，RB1，PTEN，CDKN，PIK3A，DDR, KRAS and so on.
• The end of non-systematic anti-tumor therapy is not only 2 weeks from the end of the study drug, and the treatment-related AE is restored to CTCAE 4.03 to level 1 (except for level 2 hair loss).
• Within 4 weeks prior to randomization, at least one measurable target lesions assessed by irRC in accordance with RECIST 1.1 requirements.
• The ECOG PS score for 7 days prior to the first drug use of the study drug was 0 or 1.
• The expected lifetime is more than 12 weeks.
• The main organ function sits well, i.e. meets the following criteria (no blood transfusion, albumin, recombinant human platelet production or Colony-stimulating factor (CSF) treatment within 14 days prior to the first drug use in this study):
• (1). Absolute neutrophil count \>15.0 x 10\^9/L; (2). Platelet count ≥ 100 x 10\^9/L; (3). Hemoglobins ≥ 90 g/L; (4). Total bilirubin ≤.5 x ULN (except Gilbert syndrome, total bilirubin ≤ 3.0 mg/dL); (5). AST (SGOT) ≤ 2.5 x ULN, for patients with liver metastasis, ≤5.0 x ULN; (6). ALT (SGPT) is 2.5 x ULN, for patients with liver metastasis, ≤5.0 x ULN; (7). Clotting function: activated part of the clotting enzyme time (APTT) ≤ 1.5 x ULN, clotting enzyme raw time (PT) or international standardized ratio (INR) ≤1.5 x ULN; (8). Creatinine ≤1.5xULN, or creatinine clearance ≥60 mL/min (Cockcroft-Gault method).
• \. Female patients must meet one of the following:
• Menopause (defined as having no menstruation for at least 1 year and no other reason for confirmation other than menopause);
• Sterilization performed (removal of the ovaries and/or uterus);
• Fertility, but must meet: Serum pregnancy tests must be negative within 7 days of randomization and agree to use 1% annual failure rate of contraception or to maintain abstinence (avoiding heterosexual intercourse) (at least 120 days after the signing of an informed consent form to the last time the drug was administered) (1% annual failure rate of contraceptive methods including bilateral tubal ligation, male sterilization, correct use of ovulation-suppressing hormones, release of intrauterine and intrauterine devices) and intrauterine devices.

You may not qualify if:

• Received any of the following treatments: received systemic anti-tumor therapy (except neoadjuvant or adjuvant chemotherapy) previously; Within 4 weeks before the first administration of the drug, more than 30% of the bone marrow was treated with radiotherapy or a large area of radiation was carried out (except palliative radiotherapy for the purpose of relieving pain in non-target lesions only ); Other anti-tumor therapies, including molecular targeted therapies (EGFR TKI, angiogenesis inhibitors, etc.), immunotherapy (such as cellular immunotherapy anti-PD-1 or PD-L1), other experimental drug therapies, etc.
• Major surgery was performed within 4 weeks before the first administration of the study drug.
• Patients were taking (or cannot stop taking) certain medications or herbal supplements that are known to be a strong inducer of cytopigment P450 (CYP450) 3A4 within 1 week prior to the first administration of the study drug.
• Patients with dysphagia or possible absorption disorders as determined by the researcher.
• Within 5 years or at the same time, there are other active malignancies. Cured limited tumors, such as skin base cell carcinoma, skin squamous carcinoma, superficial bladder cancer, prostate in situ cancer, cervical in situ cancer, etc. can be included in the group.
• Patients with brain metastasis, the following could except:the largest diameter of brain metastasis lesions is less than 2 cm and no obvious symptoms; brain metastatic lesions have control, and stability more than 4 weeks.
• Resting electrocardiogram (ECG) in rhythm, conduction and morphologically abnormal clinical significance, such as complete left bundle branch block, Ⅱ degrees above heart block, PR interval period \> 250 milliseconds, etc.; myocardial infarction occurred within 6 months; presence of risk factors for prolonged QT interval or increased arrhythmia, such as heart failure, moderate or severe hypokalemia, diagnosed or suspected congenital long QT syndrome, a family history of long QT syndrome, or a history of sudden death under the age of 40 in a first-degree relative; mean QT interval (QTcF) after 3 Fridericia adjustments of electrocardiogram: \> 450ms for males and \> 470ms for females.
• Pregnant or lactating women.
• Hepatitis B virus infection (HBsAg positive, HBV-DNA \>1000cps/ml and AST or ALT\>2.0xULN), hepatitis C virus infection or HIV infection which is not controlled or in active.
• Other uncontrolled concomitant diseases include, but are not limited to infectious or active infections.
• A history of epilepsy, mental illness, or other social factors that limit adherence to the program.
• The researcher considers it inappropriate to participate in this study.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

China, Zhejiang

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy; Pemetrexed; Carboplatin

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)

Therapeutics; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Study Officials

• Kai Wang, PhD

  The Fourth Affiliated Hospital of Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: September 17, 2020
• Study Start: November 23, 2020
• Primary Completion: September 24, 2023
• Study Completion: September 24, 2023
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)