Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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)

The purpose of this study is to assess the efficacy and safety of Camrelizumab plus chemotherapy in the treatment of adult participants with medically inoperable Stage I or IIA non-small cell lung cancer (NSCLC).

Studieoversigt

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

Interventionel

Tilmelding (Forventet)

30

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Lianming Zhang, PhD
  • Telefonnummer: 6417 86-22-23340123

Studiesteder

      • Tianjin, Kina, 300060
        • Rekruttering
        • Tianjin Medical University Cancer Institute and Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Patients aged ≥18 years, male and female are not limited;
  2. Patients with ECOG score of 0-1;
  3. Life expectancy ≥12 weeks;
  4. Patients must have histologically- or cytologically-documented NSCLC (according to 2015 WHO Classification);
  5. 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);
  6. Patients with measurable target lesions according to the RECIST 1.1 standard;
  7. Patients have not received prior treatment for their NSCLC, including radiotherapy, chemotherapy, surgery and target drugs;
  8. Can provide tumor tissue;
  9. Adequate organ and marrow function;
  10. 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;
  11. Provision of signed ICF.

Exclusion Criteria:

  1. Known any distance metastases;
  2. Patients with known EGFR gene mutation or ALK fusion mutation;
  3. Patients with any active autoimmune disease or history of autoimmune disease;
  4. 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;
  5. 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;
  6. Patient must not have received a live, attenuated vaccine within 4 weeks prior to the first administration;
  7. Any therapy for NSCLC treatment;
  8. Patients with other malignant tumors in the past 5 years;
  9. Patients with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and active pneumonia confirmed by imaging;
  10. Patients with cardiac insufficiency;
  11. Routine urine test indicated that urine protein was >= (+ +), or 24-hour urine protein was >= 1g, or severe liver and kidney dysfunction;
  12. Patients with severe infection or fever of unknown origin >38.5 ℃ within 4 weeks prior to the first administration;
  13. Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  14. Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures;
  15. Known allergies, hypersensitivity, or intolerance to camrelizumab or its excipients or to pemetrexed or to nab-paclitaxel;
  16. 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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
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:
  • Pemetrexed dinatrium
PD-1
Andre navne:
  • SHR-1210
Kemoterapi
Andre navne:
  • Paclitaxel for Injection(Albumin Bound)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free Survival (PFS)
Tidsramme: up to approximately 3 years
PFS is determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
up to approximately 3 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: up to approximately 5 years
OS is defined as the first date of treatment to date of death from any causes.
up to approximately 5 years
Objective response rate (ORR)
Tidsramme: up to approximately 1 years
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.
up to approximately 1 years
Disease Control Rate (DCR)
Tidsramme: up to approximately 3 years
DCR is defined as the percentage of patients who have achieved complete response and partial response per RECIST 1.1 by investigator..
up to approximately 3 years
Adverse Events (AEs)
Tidsramme: up to 18 months
The number of participants experiencing an AE will be assessed.
up to 18 months
PFS ved 12 måneder (PFS12)
Tidsramme: op til maksimalt 12 måneder
PFS vil blive beregnet ved hjælp af Kaplan-Meier produktgrænsemetoder.
op til maksimalt 12 måneder
PFS at 24 months (PFS24)
Tidsramme: up to maximum 24 months
PFS will be calculated using Kaplan-Meier product limit methods.
up to maximum 24 months
PFS at 5 years
Tidsramme: up to maximum 5 years
PFS will be calculated using Kaplan-Meier product limit methods.
up to maximum 5 years
OS på 12 måneder (OS12)
Tidsramme: op til maksimalt 12 måneder
OS vil blive beregnet ved hjælp af Kaplan-Meier-produktgrænsemetoder.
op til maksimalt 12 måneder
OS på 24 måneder (OS24)
Tidsramme: op til maksimalt 24 måneder
OS vil blive beregnet ved hjælp af Kaplan-Meier-produktgrænsemetoder.
op til maksimalt 24 måneder
OS at 5 years
Tidsramme: up to maximum 5 years
OS will be calculated using Kaplan-Meier product limit methods.
up to maximum 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. september 2020

Primær færdiggørelse (Forventet)

30. juni 2025

Studieafslutning (Forventet)

31. december 2025

Datoer for studieregistrering

Først indsendt

25. august 2020

Først indsendt, der opfyldte QC-kriterier

25. august 2020

Først opslået (Faktiske)

28. august 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. november 2020

Sidst verificeret

1. august 2020

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Pemetrexed

Abonner