- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04530227
Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage NSCLC
A Pilot Study of Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This trial will evaluate the safety and efficacy of camrelizumab in combination with chemotherapy, followed by camrelizumab alone after 4-6 cycles of combination in participants with medically inoperable stage I or IIA non-small cell lung cancer (NSCLC). The primary objective of this pilot study is to determine the Camrelizumab plus chemotherapy improves progression-free survival (PFS) . All the efficacy and safety are assessed by investigator : 1) response rate (ORR), 2) disease control rate (DCR); 3) overall survival (OS), 4) PFS rate of 1-year, 2-year, and 5-year; and 5) OS rate of 1-year, 2-year, and 5-year.
Explore objective is potential biomarker associated with efficacy.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Changli Wang, PhD
- Telefonnummer: 6417 86-22-23340123
- E-mail: wangchangli@medmail.com.cn
Undersøgelse Kontakt Backup
- Navn: Lianming Zhang, PhD
- Telefonnummer: 6417 86-22-23340123
Studiesteder
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Tianjin, Kina, 300060
- Rekruttering
- Tianjin Medical University Cancer Institute and Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients aged ≥18 years, male and female are not limited;
- Patients with ECOG score of 0-1;
- Life expectancy ≥12 weeks;
- Patients must have histologically- or cytologically-documented NSCLC (according to 2015 WHO Classification);
- Patients with stage I - IIA (T1-T2bN0M0, tumor size ≤ 50mm) confirmed by radiographic;and medical inoperable, unable to undergo thoracic surgery, or refusing to surgery (according to the eighth edition of TNM staging);
- Patients with measurable target lesions according to the RECIST 1.1 standard;
- Patients have not received prior treatment for their NSCLC, including radiotherapy, chemotherapy, surgery and target drugs;
- Can provide tumor tissue;
- Adequate organ and marrow function;
- Fertile female were required to have a serum or urine pregnancy test within 72 hours before the start dose of study medication and the result has been negative;If female of childbearing potential, is willing to use adequate contraception for the course of the study through 90 days after the last dose of study medication; if male with a female partner(s) of child-bearing potential, must agree to use adequate contraception starting with the first dose of study medication through 90 days after the last dose of study medication;
- Provision of signed ICF.
Exclusion Criteria:
- Known any distance metastases;
- Patients with known EGFR gene mutation or ALK fusion mutation;
- Patients with any active autoimmune disease or history of autoimmune disease;
- Patients with innate or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or co-infection with hepatitis B and hepatitis C;
- Subjects requiring systemic treatment with corticosteroids (> 10 mg / day of prednisone or its equivalent) or other immunosuppressants within 14 days prior to the first administration;
- Patient must not have received a live, attenuated vaccine within 4 weeks prior to the first administration;
- Any therapy for NSCLC treatment;
- Patients with other malignant tumors in the past 5 years;
- Patients with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and active pneumonia confirmed by imaging;
- Patients with cardiac insufficiency;
- Routine urine test indicated that urine protein was >= (+ +), or 24-hour urine protein was >= 1g, or severe liver and kidney dysfunction;
- Patients with severe infection or fever of unknown origin >38.5 ℃ within 4 weeks prior to the first administration;
- Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures;
- Known allergies, hypersensitivity, or intolerance to camrelizumab or its excipients or to pemetrexed or to nab-paclitaxel;
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results,or the patient is unlikely to comply with study procedures, restrictions, and requirements.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Camrelizumab combined with chemotherapy
Participants receive camrelizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 18 cycles PLUS Investigator's choice of chemotherapy. Interventions: Biological: Camrelizumab |
kemoterapi
Andre navne:
PD-1
Andre navne:
Kemoterapi
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Progression-free Survival (PFS)
Tidsramme: up to approximately 3 years
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PFS is determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
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up to approximately 3 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Survival (OS)
Tidsramme: up to approximately 5 years
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OS is defined as the first date of treatment to date of death from any causes.
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up to approximately 5 years
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Objective response rate (ORR)
Tidsramme: up to approximately 1 years
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ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by investigator.
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up to approximately 1 years
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Disease Control Rate (DCR)
Tidsramme: up to approximately 3 years
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DCR is defined as the percentage of patients who have achieved complete response and partial response per RECIST 1.1 by investigator..
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up to approximately 3 years
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Adverse Events (AEs)
Tidsramme: up to 18 months
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The number of participants experiencing an AE will be assessed.
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up to 18 months
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PFS ved 12 måneder (PFS12)
Tidsramme: op til maksimalt 12 måneder
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PFS vil blive beregnet ved hjælp af Kaplan-Meier produktgrænsemetoder.
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op til maksimalt 12 måneder
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PFS at 24 months (PFS24)
Tidsramme: up to maximum 24 months
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PFS will be calculated using Kaplan-Meier product limit methods.
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up to maximum 24 months
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PFS at 5 years
Tidsramme: up to maximum 5 years
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PFS will be calculated using Kaplan-Meier product limit methods.
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up to maximum 5 years
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OS på 12 måneder (OS12)
Tidsramme: op til maksimalt 12 måneder
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OS vil blive beregnet ved hjælp af Kaplan-Meier-produktgrænsemetoder.
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op til maksimalt 12 måneder
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OS på 24 måneder (OS24)
Tidsramme: op til maksimalt 24 måneder
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OS vil blive beregnet ved hjælp af Kaplan-Meier-produktgrænsemetoder.
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op til maksimalt 24 måneder
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OS at 5 years
Tidsramme: up to maximum 5 years
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OS will be calculated using Kaplan-Meier product limit methods.
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up to maximum 5 years
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Folinsyreantagonister
- Paclitaxel
- Albumin-bundet Paclitaxel
- Pemetrexed
Andre undersøgelses-id-numre
- MA-NSCLC-II-007
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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