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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).

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

30

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

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

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Andra namn:
  • Pemetrexed dinatrium
PD-1
Andra namn:
  • SHR-1210
kemoterapi
Andra namn:
  • Paclitaxel for Injection(Albumin Bound)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression-free Survival (PFS)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival (OS)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: up to 18 months
The number of participants experiencing an AE will be assessed.
up to 18 months
PFS vid 12 månader (PFS12)
Tidsram: upp till högst 12 månader
PFS kommer att beräknas med Kaplan-Meiers produktgränsmetoder.
upp till högst 12 månader
PFS at 24 months (PFS24)
Tidsram: up to maximum 24 months
PFS will be calculated using Kaplan-Meier product limit methods.
up to maximum 24 months
PFS at 5 years
Tidsram: up to maximum 5 years
PFS will be calculated using Kaplan-Meier product limit methods.
up to maximum 5 years
OS vid 12 månader (OS12)
Tidsram: upp till högst 12 månader
OS kommer att beräknas med Kaplan-Meiers produktgränsmetoder.
upp till högst 12 månader
OS vid 24 månader (OS24)
Tidsram: upp till max 24 månader
OS kommer att beräknas med Kaplan-Meiers produktgränsmetoder.
upp till max 24 månader
OS at 5 years
Tidsram: up to maximum 5 years
OS will be calculated using Kaplan-Meier product limit methods.
up to maximum 5 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 september 2020

Primärt slutförande (Förväntat)

30 juni 2025

Avslutad studie (Förväntat)

31 december 2025

Studieregistreringsdatum

Först inskickad

25 augusti 2020

Först inskickad som uppfyllde QC-kriterierna

25 augusti 2020

Första postat (Faktisk)

28 augusti 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 november 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 november 2020

Senast verifierad

1 augusti 2020

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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