A Single Arm, Prospective, and Exploratory Clinical Study of Camrelizumab Combined With Pemetrexed and Carboplatin in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutation Who Failed EGFR-TKI Treatment

Cancer Institute and Hospital, Chinese Academy of Medical Sciences0 sites58 target enrollmentJuly 31, 2021

ConditionsLung Cancer Stage II

InterventionsCamrelizumab+ pemetrexed + platinum

DrugsCamrelizumab+ pemetrexed + platinum

Overview

Phase: Not Applicable
Intervention: Camrelizumab+ pemetrexed + platinum
Conditions: Lung Cancer Stage II
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Enrollment: 58
Primary Endpoint: Progression-free survival
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

A single-arm, prospective, single-center, phase II, exploratory study investigating Camrelizumab combined with pemetrexed and carboplatin in the treatment of advanced non-squamous cell non-small-scale EGFR mutations (EGFR-TKI treatment failure ) Effectiveness of cell lung cancer patients

Detailed Description

In this study, eligible subject will be Subjects will have the opportunity to receive the treatment of Camrelizumab in combination with pemetrexed and carboplatin therapy .

Registry

clinicaltrials.gov

Start Date

July 31, 2021

End Date

July 30, 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Responsible Party

Principal Investigator

LIN

Assistant Professor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Eligibility Criteria

Inclusion Criteria

•The age is 18-70 years old;
•According to the TNM staging of lung cancer in the 8th edition of the International Association for the study of lung cancer and the Joint Committee on American Classification of cancer, non squamous non-small cell lung cancer confirmed by histology or cytology that can not be treated surgically and can not receive radical concurrent chemoradiotherapy and locally advanced or metastatic (stage Ⅲ B, Ⅲ C or Ⅳ) non squamous non-small cell lung cancer;
•EGFR mutation (deletion of exon 19 and L858R mutation of exon 21) was confirmed by tumor histology, cytology or hematology before EGFR / - TKI treatment;
•After EGFR-TKI treatment failure (based on RECIST v1.1, disease progression confirmed by imaging), it meets any of the following requirements:
•In the past, the first or second generation EGFR-TKI (such as icotinib, gefitinib, erlotinib, afatinib or other first or second generation EGFR-TKI listed in China) failed, and the T790M mutation of EGFR 20 exon should be confirmed by histology;
•In the past, he received the first or second generation EGFR-TKI (e.g. icotinib, gefitinib, erlotinib, afatinib), and the T790M mutation of EGFR 20 exon was confirmed by histology or hematology during or after the treatment failure. Then he received the third generation EGFR-TKI (e.g. oxitinib or other third-generation EGFR-TKI listed in China) and failed;
•The patients who received the third-generation EGFR-TKI (such as oxitinib or other third-generation EGFR-TKI listed in China) at the time of initial diagnosis of EGFR mutant NSCLC and progressed without other targeted treatment opportunities;
•No previous systemic anti-tumor therapy (except EGFR-TKI) for advanced non squamous NSCLC (for those who have received platinum neoadjuvant chemotherapy or adjuvant chemotherapy, if the disease progression occurred more than 6 months after the end of the last treatment, they are eligible to participate in this study);
•The life expectancy is at least 3 months;
•ECoG score: 0-1;

Exclusion Criteria

•Patients with active brain metastases (for patients with stable symptoms of brain metastases after treatment, keep stable for at least 4 weeks);
•Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137);
•Have received systemic anti-tumor therapy (including cytotoxic chemotherapy combined with radiotherapy) for advanced NSCLC other than EGFR-TKI in the past;
•Immunosuppressive drugs were used within 14 days before the first use of karelizumab, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e. not more than 10 mg / day prednisolone or other corticosteroids with the same physiological dose of drugs);
•Received systemic treatment of Chinese herbal medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control pleural effusion) within 2 weeks before the first administration;
•Received EGFR-TKI within 2 weeks before the first administration;
•Received palliative radiotherapy within 7 days before the first administration. For the patients who had received palliative radiotherapy 7 days before the first administration, all the following conditions must be met before they can be enrolled: there is no toxic reaction related to radiotherapy, glucocorticoid is not required, and radiation pneumonia is excluded;
•Severe cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval ≥ 450 ms for male and ≥ 470 MS for female); Grade Ⅲ - Ⅳ cardiac insufficiency (according to NYHA classification of New York Heart Association, see Annex 3), or left ventricular ejection fraction (LVEF) \< 50% by echocardiography;
•Currently participating in interventional clinical research treatment, or receiving other research drugs or research devices within 4 weeks before the first administration; Not fully recovered from toxicity and / or complications caused by any intervention before the first administration (i.e., ≤ grade 1 or baseline, excluding fatigue or hair loss);
•With uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (drainage once a month or more frequently);