Clinical Study of Combination Therapy With Ectiecinib, Pemetrexed and Platinum in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer With EGFR Mutations.

NCT03992885 | Unknown Phase 3 DMC

• 1 other identifier: E2019161
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This single-arm, open, multicenter clinical study is going to evaluate the efficacy and safety of combination therapy with ectiecinib, pemetrexed and platinum in patients with metastatic non-squamous non-small cell lung cancer with EGFR mutations who did not progress after pemetrexed in combination with platinum-based chemotherapy.

Conditions

Non-squamous Non-small Cell Lung Cancer

Keywords

the combination therapy of targeted therapy and chemotherapy; metastatic non-squamous non-small cell lung cancer with EGFR mutations; ectiecinib

Outcome Measures

Primary Outcomes (2)

• Progress free survival

  PFS was defined as the length of time from the date of randomization to the date of disease progression was first observed (as determined by imaging), and the number of days from the date of randomization to death if the patient died of other causes before the disease progression.

  5 years

• Overall survival

  OS was defined as the length of time from the date of randomization to death from any cause.Patients who are alive as of the date of analysis will have their last contact as the cut-off date.

  5 years

Secondary Outcomes (2)

• Objective response rate

  5 years

• Adverse Events

  5 years

Study Arms (1)

combination therapy with ectiecinib, pemetrexed and platinum

EXPERIMENTAL

ectinib 125mg/ tablet, one tablet at a time, three times a day, take orally;Pemetrexed 500mg/m2, intravenous infusion, day 1;Carboplatin AUC6/ Cisplatin 75mg/m2,intravenous infusion, day 1,21 days for a cycle, a total of 6 cycles.Maintenance therapy: ectinib: ectinib 125mg/ tablet, one tablet at a time, three times a day, take orally, pemetrexed 500mg/m2,d intravenous infusion, day 1,21 days for a cycle

Drug: Icotinib

Interventions

Icotinib DRUG

Intervention: Drug: Icotinib Ectinib 125mg/ tablet, one tablet at a time, three times a day, take orally Intervention: Drug: Carboplatin/ Cisplatin Pemetrexed 500mg/m2, intravenous infusion, day 1;Carboplatin AUC6/ Cisplatin 75mg/m2,intravenous infusion, day 1,21 days for a cycle

Also known as: Pemetrexed, platinum

combination therapy with ectiecinib, pemetrexed and platinum

Eligibility Criteria

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

You may qualify if:

• Age 18-75;
• Expected survival is at least 12 weeks;
• Metastatic non-squamous non-small cell lung cancer with EGFR mutations confirmed by histological or cytological examination;
• Received two cycles of pemetrexed/platinum chemotherapy with no progress (efficacy was evaluated as SD or PR);
• Tumor specimens must be provided before patients receive ectinib combined chemotherapy to complete the EGFR gene test. There is no need to clarify the EGFR mutation status before the initial pemetrexed/platinum chemotherapy;
• Volunteers who participate in exploratory studies need provide tumor samples for the laboratory to complete the study on anti-tumor drug sensitivity of microfluidic chip technology;
• Volunteers who participate in exploratory studies need provide blood samples to complete the analysis of blood biomarkers and disease progression/anti-tumor efficacy, tolerance and safety of drugs;
• ECOG score;
• Patients may have a history of brain parenchymal metastasis, and local treatment (surgery and/or radiotherapy) is required for good control of symptoms, and hormone maintenance therapy is not required;
• According to RECIST criteria 1.1, there is at least one measurable lesion that has not been irradiated:1) if there is at least one measurable lesion, and if there is only one lesion, the nature of new organisms at the lesion site must be confirmed by cytology or histology;2) for patients with at least one lesion diameter that can be accurately measured by any of the following methods, computed tomography (CT) or magnetic resonance (MRI) of chest or abdomen, the diameter of which should be at least 20mm by conventional methods or at least 10mm by spiral CT;
• The level of organ function must meet the following requirements:1) bone marrow: median granulocyte absolute count (ANC) ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥9 g/dL;2) liver: serum bilirubin ≤1.5 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5 times the upper limit of normal value (ALT ≤ 5 times the upper limit of normal value if there is liver metastasis);3) upper limit of serum creatinine \<1.5 times normal value;Creatinine clearance ≥50 mL/min (calculated by cockroft-gault10 formula) for patients with low body weight or patients with significantly different values calculated by the two formulas, it is recommended to measure creatinine clearance by other methods, such as EDTA method, inulin clearance method, or 24-hour urinalysis.4) international standardized ratio of prothrombin time (INR) ≤1.5 and partial thrombin time (APTT) ≤1.5 upper limit of normal value in patients who have not received anticoagulation therapy.Patients receiving full or parenteral anticoagulant therapy can enter the clinical trial as long as the dose of anticoagulant is stable for at least 2 weeks before entering the clinical study and the results of coagulation test are within the limits of local treatment.
• Women of reproductive age must have negative serum pregnancy test results within 7 days prior to treatment;All enrolled patients (male or female) should take adequate barrier contraception during and within 4 weeks after treatment;
• Patients must be able to understand and sign informed consent voluntarily, prior to any trial procedures.

You may not qualify if:

• Previous EGFR-TKIs targeted drug therapy;
• Allergic history or hypersensitivity history of patients to active ingredients or non-active excipients of experimental drugs, drugs with chemical structure similar to experimental drugs, or similar drugs of experimental drugs;
• Known CYP inhibitors or inducers, such as phenytoin, carbamazepine, rifampicin, barbiturate, or st. John's wort, are currently being used (or cannot be discontinued within 1 week prior to the first administration);
• Patient's organs and systems:1) patients with brain/meningeal metastasis (except those who do not need hormone maintenance therapy after local treatment for brain parenchymal metastasis is controlled);2) having had interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy, or any active interstitial lung disease with clinical evidence, and having had idiopathic pulmonary fibrosis on CT scan at baseline;Uncontrolled massive pleural or pericardial effusion;3) evidence of serious or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, heart, liver or kidney disease), as determined by the investigator;4) any unstable systemic disease (including active \>CTCAE grade 2 clinical severe infection, grade 4 hypertension, unstable angina pectoris, congestive heart failure, human immunodeficiency virus (HIV) infection, liver, kidney or metabolic disease);5) any other malignancy (other than fully cured cervical carcinoma in situ or basal or squamous cell skin cancer) within 5 years;6) a clear history of neurological or psychiatric disorders, including epilepsy or dementia;7) patients with a history of allogeneic organ transplantation;Patients who underwent major surgery or suffered severe trauma within 4 weeks prior to first administration;8) more than 30% of the experimental drugs received extensive radiotherapy or bone marrow radiotherapy within 4 weeks before the first administration;
• Any conditions that affect the swallowing or absorption of medications, such as refractory nausea and vomiting, inability to swallow test medications, history of any type of gastrointestinal tract resection or surgery;
• Pregnant or lactating females (males and females participating in this study must take adequate barrier contraceptive measures during and within 4 weeks after the end of the study);
• Existing substance abuse and medical, psychological or social conditions that may interfere with patients participating in or evaluating research results;
• Any unstable or potentially compromising patient safety and compliance with the study.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Department of Pulmonary Medical Oncology, Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Publications (2)

• Mehic B, Duranovic Rayan L, Bilalovic N, Dohranovic Tafro D, Pilav I. Lung adenocarcinoma mimicking pulmonary fibrosis-a case report. BMC Cancer. 2016 Sep 13;16(1):729. doi: 10.1186/s12885-016-2763-6.

  PMID: 27619516 RESULT

• Inoue A, Kobayashi K, Maemondo M, Sugawara S, Oizumi S, Isobe H, Gemma A, Harada M, Yoshizawa H, Kinoshita I, Fujita Y, Okinaga S, Hirano H, Yoshimori K, Harada T, Saijo Y, Hagiwara K, Morita S, Nukiwa T; North-East Japan Study Group. Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin-paclitaxel for chemo-naive non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002). Ann Oncol. 2013 Jan;24(1):54-9. doi: 10.1093/annonc/mds214. Epub 2012 Sep 11.

  PMID: 22967997 RESULT

MeSH Terms

Interventions

icotinib; Pemetrexed; Platinum

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; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Peng Chen, M.D.

  Department of Pulmonary Medical Oncology, Tianjin Medical University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Chen, M.D.

CONTACT

+86-18622221220; chenpengdoc@sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: EGFR-positive patients with metastatic non-squamous non-small cell lung cancer who did not progress after pemetrexed combined with platinum chemotherapy

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 20, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2025
• Last Updated: June 20, 2019

Record last verified: 2019-06

Locations

CN (1)