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Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage NSCLC

Primary Purpose

Early Stage Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Biological: Camrelizumab
Pemetrexed
Nab-paclitaxel
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Stage Non-small Cell Lung Cancer focused on measuring programmed cell death 1 (PD-1, PD1), programmed cell death-ligand 1 (PD-L1, PDL1)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Camrelizumab combined with chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
PFS is determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

Secondary Outcome Measures

Overall Survival (OS)
OS is defined as the first date of treatment to date of death from any causes.
Objective response rate (ORR)
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.
Disease Control Rate (DCR)
DCR is defined as the percentage of patients who have achieved complete response and partial response per RECIST 1.1 by investigator..
Adverse Events (AEs)
The number of participants experiencing an AE will be assessed.
PFS at 12 months (PFS12)
PFS will be calculated using Kaplan-Meier product limit methods.
PFS at 24 months (PFS24)
PFS will be calculated using Kaplan-Meier product limit methods.
PFS at 5 years
PFS will be calculated using Kaplan-Meier product limit methods.
OS at 12 months (OS12)
OS will be calculated using Kaplan-Meier product limit methods.
OS at 24 months (OS24)
OS will be calculated using Kaplan-Meier product limit methods.
OS at 5 years
OS will be calculated using Kaplan-Meier product limit methods.

Full Information

First Posted
August 25, 2020
Last Updated
November 10, 2020
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04530227
Brief Title
Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage NSCLC
Official Title
A Pilot Study of Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Stage Non-small Cell Lung Cancer
Keywords
programmed cell death 1 (PD-1, PD1), programmed cell death-ligand 1 (PD-L1, PDL1)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Camrelizumab combined with chemotherapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Biological: Camrelizumab
Other Intervention Name(s)
SHR-1210
Intervention Description
PD-1
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Pemetrexed Disodium
Intervention Description
chemotherapy
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Other Intervention Name(s)
Paclitaxel for Injection(Albumin Bound)
Intervention Description
chemotherapy
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
PFS is determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Time Frame
up to approximately 3 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the first date of treatment to date of death from any causes.
Time Frame
up to approximately 5 years
Title
Objective response rate (ORR)
Description
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.
Time Frame
up to approximately 1 years
Title
Disease Control Rate (DCR)
Description
DCR is defined as the percentage of patients who have achieved complete response and partial response per RECIST 1.1 by investigator..
Time Frame
up to approximately 3 years
Title
Adverse Events (AEs)
Description
The number of participants experiencing an AE will be assessed.
Time Frame
up to 18 months
Title
PFS at 12 months (PFS12)
Description
PFS will be calculated using Kaplan-Meier product limit methods.
Time Frame
up to maximum 12 months
Title
PFS at 24 months (PFS24)
Description
PFS will be calculated using Kaplan-Meier product limit methods.
Time Frame
up to maximum 24 months
Title
PFS at 5 years
Description
PFS will be calculated using Kaplan-Meier product limit methods.
Time Frame
up to maximum 5 years
Title
OS at 12 months (OS12)
Description
OS will be calculated using Kaplan-Meier product limit methods.
Time Frame
up to maximum 12 months
Title
OS at 24 months (OS24)
Description
OS will be calculated using Kaplan-Meier product limit methods.
Time Frame
up to maximum 24 months
Title
OS at 5 years
Description
OS will be calculated using Kaplan-Meier product limit methods.
Time Frame
up to maximum 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changli Wang, PhD
Phone
86-22-23340123
Ext
6417
Email
wangchangli@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lianming Zhang, PhD
Phone
86-22-23340123
Ext
6417
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changli Wang

12. IPD Sharing Statement

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Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage NSCLC

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