Camrelizumab Combined With Pemetrexed and Carboplatin for the Study of EGFR-mutated Lung Squamous NSCLC Treatment

NCT04970043 | Unknown

• 1 other identifier: BJ-NSCLC-IIT-Camrelizumab
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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

Conditions

Lung Cancer Stage II

Keywords

Non-small Cell Lung Cancer; PD-1 Antibody

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  From the date Into this study to tumor progression or death for any

  1 Year

Secondary Outcomes (4)

• Objective response rate

  2 Year

• Overall survival

  2 Year

• Disease Control Rate

  2 Year

• Duration of Response

  2 Year

Study Arms (1)

Camrelizumab+ pemetrexed + platinum

EXPERIMENTAL

Drug: Camrelizumab+ pemetrexed + platinum

Interventions

Camrelizumab+ pemetrexed + platinum DRUG

Induction period: (4-6 cycles) Camrelizumab: a fixed dose of 200 mg, intravenous drip for 30-60 minutes, the first day, every 3 weeks as a cycle. Pemetrexed: 500 mg / m2, given on the first day, every 3 weeks as a cycle; Carboplatin: AUC = 4-5, given on the first day, every 3 weeks as a cycle; After 4-6 cycles of treatment, the patients entered the maintenance treatment period of carrizumab combined with pemetrexed. Maintenance treatment period: Camrelizumab: a fixed dose of 200 mg, intravenous drip for 30-60 minutes, the first day, every 3 weeks as a cycle. Pemetrexed: 500 mg / m2, given on the first day, every 3 weeks as a cycle; Every 3 weeks is a treatment cycle, and the drug is maintained until the following conditions occur: disease progression, intolerable toxicity, or receiving immunotherapy for no more than 35 cycles (2 years).

Camrelizumab+ pemetrexed + platinum

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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;
• \. According to recist1.1, the researcher confirmed that there was at least one measurable lesion;
• \. The function of main organs is normal, and the test results must meet the following requirements:
• The standard of blood routine examination should be met (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors)
• A. Hemoglobin (HB) ≥ 90 g / L;
• B. Neutrophil count (ANC) ≥ 2 × 109/L；

You may not qualify if:

• \. 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);
• \. Subjects have received or plan to receive solid organ or blood system transplantation (except corneal transplantation) during the study period;
• \. Patients with active autoimmune disease or immunodeficiency, or with the above history, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc.) were not included. The following exceptions: Patients with a history of autoimmune hypothyroidism but receiving thyroid hormone replacement therapy were included in the study. Patients with type 1 diabetes whose blood glucose is controlled after insulin administration can participate in this study.
• \. Subjects who received systemic therapy such as bronchodilators were not satisfied with asthma control and could not be included (those who had complete remission of asthma in childhood and did not need any intervention in adulthood could be included).
• \. Severe infection occurred within 4 weeks before the first administration (e.g. need for intravenous drip of antibiotics, antifungal or antiviral drugs), or fever of unknown origin \> 38.5 ° C occurred during the screening period / before the first administration; Or received major surgical treatment within 3 weeks before the first medication;
• \. Inoculate live attenuated vaccine within 30 days of the first administration or expected during the study period;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Platinum

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• lin Lin, doctor

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

lin Lin, doctor

CONTACT

13910388770; doctor.linlin@outlook.com

lin Wang, doctor

CONTACT

139911085229

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 21, 2021
• Study Start: July 31, 2021
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share