Clinical Trials /

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

NCT04592666

Description:

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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Almonertinib/Pemetrexed/Carboplatin in EGFR T790M+ Advanced Lung Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: ALMO-PEME-CAR-01
  • NCT ID: NCT04592666

Conditions

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

Interventions

DrugSynonymsArms
AlmonertinibCombinational therapy
PemetrexedCombinational therapy
CarboplatinCombinational therapy

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Combinational therapyExperimental
  • Almonertinib
  • Pemetrexed
  • Carboplatin
Single TKIActive Comparator
  • Almonertinib

Eligibility Criteria

        Inclusion Criteria:

          1. Between 18 and 75 years old (including 18 and 75 years old);

          2. Histologically or cytologically confirmed locally advanced or metastatic (STAGE
             IIIB-IV) NSCLC does not accept simple sputum smear-based diagnosis;

          3. 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.

          4. 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.

          5. Life expectancy is at least 3 months;

          6. ECOG score: 0-1, with no significant clinical deterioration in the past 2 weeks;

          7. 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);

        Exclusion Criteria:

          1. Patients who have received three generations of EGFR-TKI treatment;

          2. Patients with mixed small cell lung cancer components;

          3. 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;

          4. Patients with symptomatic brain metastasis, meningeal metastasis or spinal cord
             compression;

          5. Patients with previous diagnosis of interstitial pneumonia;

          6. Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood
             pressure ≥90 mmHg, despite the best medication);

          7. 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%;

          8. 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.

          9. Peripheral neuropathy ≥CTCAE 2 is present, except for trauma;

         10. Respiratory syndrome (≥CTCAE level 2 dyspnea), uncontrolled serous cavity effusion
             (including pleural effusion, ascites and pericardial effusion);

         11. A wound or fracture that has not been healed for a long time;

         12. Severe infections requiring systemic antibiotics;

         13. Decompensated diabetes mellitus or other contraindications of high-dose glucocorticoid
             therapy;

         14. Active hepatitis C and/or hepatitis B infection (hepatitis B: HBsAg positive with HBV
             DNA≥500IU/mL;Hepatitis C: HCV RNA positive);

         15. Factors that significantly affect oral drug absorption, such as inability to swallow,
             chronic diarrhea, and intestinal obstruction;

         16. Had major surgery or severe traumatic injury, fracture or ulcer within the first 4
             weeks;

         17. Any contraindications for platinum (carboplatin) and cytotoxic drug (Pemetrexed)
             treatment;

         18. Other conditions deemed inappropriate by the researcher for inclusion in the study.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:PFS
Time Frame:from the first cycle of treatment (day one) to two month after the last cycle (each cycle is 21 days)
Safety Issue:
Description:progression free survival

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Fudan University

Trial Keywords

  • lung cancer
  • EGFR
  • Combination therapy
  • Almonertinib

Last Updated

October 15, 2020