- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT04970043
Camrelizumab Combined With Pemetrexed and Carboplatin for the Study of EGFR-mutated Lung Squamous NSCLC Treatment
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
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
Tanulmány típusa
Beiratkozás (Várható)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: lin Lin, doctor
- Telefonszám: 13910388770
- E-mail: doctor.linlin@outlook.com
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: lin Wang, doctor
- Telefonszám: 139911085229
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
1. The age is 18-70 years old;
2. 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;
3. EGFR mutation (deletion of exon 19 and L858R mutation of exon 21) was confirmed by tumor histology, cytology or hematology before EGFR / - TKI treatment;
4. 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;
5. 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);
6. The life expectancy is at least 3 months;
7. ECoG score: 0-1;
8. According to recist1.1, the researcher confirmed that there was at least one measurable lesion;
9. 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;
C. Platelet count (PLT) ≥ 100 × 109/L;
Biochemical tests should meet the following standards:
A. Total bilirubin (TBIL) < 1.5 upper limit of normal (ULN);
B. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5uln, but < 5uln for patients with liver metastasis;
C. Serum creatinine (CR) ≤ 1.5 ULN or endogenous creatinine clearance > 60 ml / min (Cockcroft Gault formula);
D. Urine routine test results showed that urinary protein (Upro) < 2 + or 24-hour urinary protein < 1g;
10. Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they are willing to use appropriate contraceptive methods during the test period and 60 days after the last administration of the test drug. For men, it is necessary to agree to use appropriate contraceptive methods or surgical sterilization during the trial period and 120 days after the last administration of the trial drug;
11. Signed the written informed consent, and expected to have good compliance with the research protocol.
Exclusion Criteria:
1. Patients with active brain metastases (for patients with stable symptoms of brain metastases after treatment, keep stable for at least 4 weeks);
2. 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);
3. Have received systemic anti-tumor therapy (including cytotoxic chemotherapy combined with radiotherapy) for advanced NSCLC other than EGFR-TKI in the past;
4. 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);
5. 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;
6. Received EGFR-TKI within 2 weeks before the first administration;
7. 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;
8. 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;
9. 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);
10. With uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (drainage once a month or more frequently);
11. Subjects have received or plan to receive solid organ or blood system transplantation (except corneal transplantation) during the study period;
12. 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.
13. 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).
14. 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;
15. Inoculate live attenuated vaccine within 30 days of the first administration or expected during the study period;
16.16. Human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS), untreated active hepatitis B, hepatitis C virus (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of analysis method) or combined hepatitis B and hepatitis C common sense;
Note: the hepatitis B subjects who met the following criteria also met the inclusion criteria: HBV viral load must be <1000 copy /ml (200 IU/ml) before the first dose, and the subjects should be treated with anti HBV therapy during the whole chemotherapy course to avoid virus reactivation. For the subjects with anti HBC (+), HBsAg (-), anti HBS (-) and HBV viral load (-), preventive anti HBV treatment is not necessary, but close monitoring of virus reactivation is needed;
17. Patients with a clear history of allergy are known to have allergic reactions to carrizumab, pemetrexed, carboplatin or cisplatin active ingredients and or any excipients;
18. Those who have a history of psychotropic drug abuse and can not give up or have mental disorders;
Other conditions that increase the risk associated with participating in the study or the study drug and, in the judgment of the investigator, may result in patients not suitable for inclusion in the study.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Kísérleti: Camrelizumab+ pemetrexed + platinum
|
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). |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Progressziómentes túlélés
Időkeret: 1 év
|
A vizsgálat időpontjától a daganat progressziójáig vagy bármely betegség haláláig
|
1 év
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Objektív válaszadási arány
Időkeret: 2 év
|
ez azoknak a betegeknek az aránya, akiknél a daganatok előre meghatározott méretre zsugorodnak, és fenntartanak egy minimális időkorlátot.
Ez magában foglalja a CR és a PR eseteit.
|
2 év
|
Betegségellenőrzési arány
Időkeret: 2 év
|
a CR, PR plusz SD aránya
|
2 év
|
A válasz időtartama
Időkeret: 2 év
|
Cr vagy PR a PD vagy bármilyen okból bekövetkezett halál első vizsgálatához
|
2 év
|
Overall survival
Időkeret: 2 Year
|
The time from the beginning of treatment to the death of the subject due to various reasons, calculated by the intended treatment population
|
2 Year
|
Együttműködők és nyomozók
Nyomozók
- Kutatásvezető: lin Lin, doctor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Várható)
Elsődleges befejezés (Várható)
A tanulmány befejezése (Várható)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- BJ-NSCLC-IIT-Camrelizumab
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
Klinikai vizsgálatok a Tüdőrák II
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Még nincs toborzásAnatómiai Stage II Breast Cancer AJCC v8 | Anatómiai Stage III Breast Cancer AJCC v8 | Korai stádiumú emlőkarcinóma | Anatómiai Stage I Breast Cancer American Joint Committee on Cancer (AJCC) v8Egyesült Államok
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)ToborzásAnatómiai stádiumú emlőrák AJCC v8 | Anatómiai Stage II Breast Cancer AJCC v8 | Anatómiai Stage III Breast Cancer AJCC v8Egyesült Államok
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Fred Hutchinson Cancer CenterMég nincs toborzásAnatómiai stádiumú emlőrák AJCC v8 | Anatómiai Stage II Breast Cancer AJCC v8 | Anatómiai Stage III Breast Cancer AJCC v8Egyesült Államok
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)ToborzásAnatómiai stádiumú emlőrák AJCC v8 | Anatómiai Stage II Breast Cancer AJCC v8 | Anatómiai Stage III Breast Cancer AJCC v8Egyesült Államok
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institute on Aging (NIA)ToborzásAnatómiai stádiumú emlőrák AJCC v8 | Anatómiai Stage II Breast Cancer AJCC v8 | Anatómiai Stage III Breast Cancer AJCC v8Egyesült Államok
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Mayo ClinicNational Cancer Institute (NCI)ToborzásAnatómiai stádiumú emlőrák AJCC v8 | Anatómiai Stage II Breast Cancer AJCC v8 | Anatómiai Stage III Breast Cancer AJCC v8Egyesült Államok
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University of Southern CaliforniaNational Cancer Institute (NCI)ToborzásAnatómiai stádiumú emlőrák AJCC v8 | Anatómiai Stage II Breast Cancer AJCC v8 | Anatómiai Stage III Breast Cancer AJCC v8 | Invazív emlőkarcinómaEgyesült Államok
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City of Hope Medical CenterNational Cancer Institute (NCI)ToborzásAnatómiai stádiumú emlőrák AJCC v8 | Anatómiai Stage II Breast Cancer AJCC v8 | Anatómiai Stage III Breast Cancer AJCC v8 | HER2-negatív emlőkarcinómaEgyesült Államok
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SWOG Cancer Research NetworkNational Cancer Institute (NCI)ToborzásAnatómiai stádiumú emlőrák AJCC v8 | Anatómiai Stage II Breast Cancer AJCC v8 | Anatómiai Stage III Breast Cancer AJCC v8 | Hormonreceptor-pozitív emlőkarcinómaEgyesült Államok, Peru
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Mayo ClinicToborzásAnatómiai stádiumú emlőrák AJCC v8 | Anatómiai Stage II Breast Cancer AJCC v8 | Anatómiai Stage III Breast Cancer AJCC v8Egyesült Államok
Klinikai vizsgálatok a Camrelizumab+ pemetrexed + platinum
-
Zhejiang Cancer HospitalIsmeretlen
-
Peking UniversityMég nincs toborzás
-
Hebei Medical University Fourth HospitalToborzás
-
Nanfang Hospital of Southern Medical UniversityToborzásNasopharyngealis karcinóma | Oligometasztázis | RadioterápiaKína
-
Fujian Medical University Union HospitalToborzásRadioterápia | Immun terápia | Nyelőcső neoplazmaKína
-
Cancer Institute and Hospital, Chinese Academy...Még nincs toborzás
-
Fudan UniversityToborzás
-
Henan Cancer HospitalJiangsu HengRui Medicine Co., Ltd.Még nincs toborzás
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityMég nincs toborzás
-
Jiangxi Provincial Cancer HospitalToborzásHáromszoros negatív mellrákKína