Almonertinib/Pemetrexed/Carboplatin in EGFR T790M+ Advanced Lung Cancer

NCT04592666 | Unknown Phase 2

• 1 other identifier: ALMO-PEME-CAR-01
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

Almonertinib Plus Pemetrexed and Carboplatin Versus Almonertinib Alone in Advanced NSCLC With EGFR T790M After First- or Second-generation TKIs Therapy: a Randomized, Controlled, Open-label, Phase 2 Study

Conditions

Lung Cancer, Non-small Cell; EGFR T790M; EGFR Gene Mutation

Keywords

lung cancer; EGFR; Combination therapy; Almonertinib

Outcome Measures

Primary Outcomes (1)

• PFS

  progression free survival

  from the first cycle of treatment (day one) to two month after the last cycle (each cycle is 21 days)

Study Arms (2)

Combinational therapy

EXPERIMENTAL

Drug: Almonertinib; Drug: Pemetrexed; Drug: Carboplatin

Single TKI

ACTIVE COMPARATOR

Drug: Almonertinib

Interventions

Almonertinib DRUG

the standard therapy of single agent almonertinib

Combinational therapy; Single TKI

Pemetrexed DRUG

standard dose

Combinational therapy

Carboplatin DRUG

AUC=5

Combinational therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 and 75 years old (including 18 and 75 years old);
• Histologically or cytologically confirmed locally advanced or metastatic (STAGE IIIB-IV) NSCLC does not accept simple sputum smear-based diagnosis;
• Previous genetic tests confirmed egFR-sensitive mutations, and received one or two generations of EGFR TKI treatment. After drug resistance, it was confirmed to be positive for EGFR T790M mutation by biopsy or free DNA test.
• The patient has at least one tumor lesion that has not received local treatment such as radiation or biopsy in the screening stage, and can be accurately measured at baseline, with the longest diameter ≥ 10mm at baseline (short diameter ≥ 15mm if lymph nodes are involved).The measurement method chosen is suitable for accurate repeated measurements and can be computed tomography (CT) or magnetic resonance imaging (MRI).If there is only one measurable lesion and no previous local treatment such as irradiation, it can be accepted as the target lesion for baseline evaluation of tumor lesions after at least 14 days of diagnostic biopsy.
• Life expectancy is at least 3 months;
• ECOG score: 0-1, with no significant clinical deterioration in the past 2 weeks;
• The main organs function normally, that is, they meet the following standards:
• blood routine examination standards must be in accordance with no blood transfusion and adjuvant therapies (14 days) : A. Hemoglobin (HB) ≥90 g/L; B. Absolute value of neutrophils (ANC) ≥1.5×109/L; C. Platelet (PLT) ≥100×109/L; D. Total bilirubin (TBIL) \<1.5 times the upper limit of normal value (ULN); E. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2.5×ULN, if accompanied by liver metastasis, ALT and AST\< 5×ULN; F. Serum Cr\<1.25×ULN or endogenous creatinine clearance rate (CCr) \> 45 ml/min (Cockcroft-Gault formula);

You may not qualify if:

• Patients who have received three generations of EGFR-TKI treatment;
• Patients with mixed small cell lung cancer components;
• Patients with advanced or metastatic disease who have received palliative chemotherapy, or patients with tumor recurrence and metastasis within 6 months after radical surgery with adjuvant chemotherapy;
• Patients with symptomatic brain metastasis, meningeal metastasis or spinal cord compression;
• Patients with previous diagnosis of interstitial pneumonia;
• Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite the best medication);
• with severe cardiovascular disease: Ⅱ magnitude of myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc interphase male 450, female 470 ms or ms or higher);According to NYHA standard, Ⅲ \~ Ⅳ cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) \< 50%;
• abnormal coagulation function (INR \>1.5 or prothrombin time (PT) \> ULN+4 seconds or APTT \> 1.5uln), bleeding tendency or receiving thrombolytic or anticoagulant therapy; Note: Under the condition that the international standard ratio of prothrombin time (INR) ≤1.5, low-dose heparin (daily dosage for adults ranges from 66,000 to 12,000 U) or low-dose aspirin (daily dosage ≤100 mg) is allowed for preventive purposes.
• Peripheral neuropathy ≥CTCAE 2 is present, except for trauma;
• Respiratory syndrome (≥CTCAE level 2 dyspnea), uncontrolled serous cavity effusion (including pleural effusion, ascites and pericardial effusion);
• A wound or fracture that has not been healed for a long time;
• Severe infections requiring systemic antibiotics;
• Decompensated diabetes mellitus or other contraindications of high-dose glucocorticoid therapy;
• Active hepatitis C and/or hepatitis B infection (hepatitis B: HBsAg positive with HBV DNA≥500IU/mL;Hepatitis C: HCV RNA positive);
• Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

aumolertinib; Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 19, 2020
• Study Start: October 9, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

CN (1)