A Study to Evaluate SHR-1210 in Combination With Famitinib Plus Chemotherapy in Subjects With NSCLC.

March 11, 2021 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Multi-center, Randomized, Double-blind, Phase III Trial of SHR-1210 in Combination With Famitinib or Placebo Plus Chemotherapy in Subjects With Non-squamous Non-small-cell Lung Cancer.

The study is being conducted to evaluate the efficacy and safety of SHR-1210 in combination with Famitinib plus chemotherapy in subjects with NSCLC.

Study Overview

Detailed Description

The study is being conducted to evaluate the efficacy and safety of Camrelizumab in combination with Famitinib plus chemotherapy in subjects with NSCLC.

Study Type

Interventional

Enrollment (Anticipated)

560

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100089
        • Not yet recruiting
        • Beijing Cancer Hosipital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospita
        • Contact:
          • Sheng Hu, Doctor
          • Phone Number: +86-27-87670003
          • Email: ehusmn@163.com
    • Liaoning
      • Shenyang, Liaoning, China, 110022
        • Recruiting
        • Shengjing Hospita of China Medical University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Shanghai Lung Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Not yet recruiting
        • West China Hospital,Sichuan University
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
          • Xiubao Ren, Doctor
          • Phone Number: +86-18622221235
          • Email: rwziyi@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed Informed Consent Form, male or female, 18-70 years of age.
  2. Histologically or cytologically confirmed, Stage IIIB-IV non-squamous NSCLC
  3. EGFR mutation and ALK rearrangement status must be negative.
  4. No prior system chemotherapy for advanced/metastatic NSCLC.
  5. Measurable diseaseas defined by RECIST v1.1.
  6. ECOG performance status of 0 or 1.
  7. Has a life expectancy of at least 3 months.
  8. Adequater organ function.
  9. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose, and be willing to use a recognized effective contraceptive measure during the study and within 3 months after the last dose of the study drug; Male subjects with partners of childbearing potential must either be surgically sterilized or agree to take effective contraceptive measures during the study and within 3 months after the last dose of the study drug.

Exclusion Criteria:

1、 Cancer-Specific Exclusions

  1. Other histological types of non-small cell lung cancer.
  2. Subjects with carcinomatous meningitis and spinal cord compression.
  3. Subjects with untreated central nervous system (CNS) metastasis.
  4. Subjects who can be treated with surgical resection or radical radiotherapy.
  5. Subjects who previously received anti-PD-1(L1) or CTLA4 monoclonal antibody, VEGF or VEGFR signaling pathway single target/multiple target inhibitor or monoclonal antibodies.

2. Medical history and complications

  1. Subjects with any active, known, or suspected autoimmune diseases.
  2. Subjects who require systemic corticosteroids prednisone (> 10 mg/day or equivalent) or other immunosuppressants within 14 days prior to the first dose.
  3. Subjects who received cancer vaccines or other immunostimulatory anti-cancer agents (interferon, interleukin, thymosin, or immune cell therapy) within 1 month prior to the first dose.
  4. Subjects who received anti-cancer TCM within 14 days prior to the first dose.
  5. Subjects who are in another clinical study or last participated (last dose) in a clinical study less than 4 weeks (or 5 half-lives of the study drug) from the first dose, whichever is shorter.
  6. Subjects who are expected to require other forms of anti-cancer treatment during the study.
  7. Subjects who received major surgery within 4 weeks prior to the first dose, non-thoracic radiation therapy > 30 Gy within 4 weeks prior to the first dose, thoracic radiation therapy > 30 Gy within 24 weeks prior to the first dose, or palliative radiation ≤ 30 Gy within 2 weeks prior to the first dose, and failed to recover from the toxicities and/or complications of these interventions to NCI-CTC AE Grade ≤ 1 (except for alopecia and fatigue). Palliative radiotherapy for symptomatic control is permitted, but must be completed within 2 weeks prior to starting the study treatment.
  8. Subjects highly suspected of interstitial lung disease, or with conditions that may interfere with the testing or management of suspected treatment-related pulmonary toxicities, or other moderate to severe lung diseases that seriously affect pulmonary function.
  9. Subjects with a history of malignant tumors.
  10. Subjects with severe cardiovascular disease.
  11. Subjectss with hypertension which cannot be well controlled by antihypertensives.
  12. Subjects with clinically significant hemorrhage or clear bleeding tendency within 3 month prior to the first dose.
  13. Events of arterial/venous thrombosis within 6 months prior to the first dose.
  14. Subjects who require long-term anticoagulant therapy with warfarin or heparin.
  15. Subjects who require long-term antiplatelet therapy.
  16. Significant vascular invasions or a high possibility of significant vascular invasions that may cause bleeding as determined by the investigator during treatment.
  17. Subjects with active pulmonary tuberculosis (TB).
  18. Subjects with serious infection within 4 weeks prior to the first dose, including but not limited to infective complications, bacteremia, and severe pneumonia that require hospitalization.
  19. Subjects who prepare to receive or have previously received tissue/organ transplants.
  20. Gastrointestinal disorder or surgical history that may affect the swallowing, digestion, and absorption of the oral drug as determined by the investigator.
  21. Subjects who plan to receive or have received live vaccines within 30 days prior to the first dose.
  22. Subjects with uncontrolled cancer pain.

3. Physical examination and laboratory tests

  1. Known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS).
  2. Active hepatitis B virus or hepatitis C virus infection.
  3. Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.

4. Allergies and adverse drug reactions

  1. Severe allergic reactions to other monoclonal antibodies.
  2. Allergy or intolerance during an infusion.
  3. History of severe allergies to pemetrexed, carboplatin, or their premedications.

5. Subjects with mental illness, alcohol abuse, inability to quit smoking, and drug or substance abuse.

6. Based on the investigator's judgment, subjects with a history or current evidence of diseases, treatments, or laboratory abnormalities that may affect study results, interfere with study procedures, or are not in the best interests of the subjects, should be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment group A
Intervention Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib

Part 1:

Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib

Part 2:

Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib

Other Names:
  • SHR1210
PLACEBO_COMPARATOR: Treatment group B
Intervention Drug: Camrelizumab; Pemetrexed; Carboplatin; Placebo

Part 2:

Drug: Camrelizumab; Pemetrexed; Carboplatin; Placebo

Other Names:
  • SHR1210

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part 1:Serum concentrations of Camrelizumab
Time Frame: Cycle 2; each cycle is 21 days (up to 42 days)
Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Plasma concentrations of Famitinib
Time Frame: Cycle 2; each cycle is 21 days (up to 42 days)
Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Area Under the Plasma Concentration Versus Time Curve (AUC) of Famitinib.
Time Frame: Cycle 2; each cycle is 21 days (up to 42 days)
Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Maximum Concentration (Cmax) of Famitinib.
Time Frame: Cycle 2; each cycle is 21 days (up to 42 days)
Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Time to Maximum Concentration (Tmax) of Famitinib.
Time Frame: Cycle 2; each cycle is 21 days (up to 42 days)
Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Half-life (t1/2 z) of Famitinib.
Time Frame: Cycle 2; each cycle is 21 days (up to 42 days)
Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Apparent Clearance (CL/F) of Famitinib
Time Frame: Cycle 2; each cycle is 21 days (up to 42 days)
Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Vz/F of Famitinib.
Time Frame: Cycle 2; each cycle is 21 days (up to 42 days)
Cycle 2; each cycle is 21 days (up to 42 days)
Part 2: Progression-free Survival (PFS) as Assessed by BICR according to RECIST 1.1.
Time Frame: up to 24 months
up to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Part 1:Objective Response Rate (ORR) as Assessed by investigators
Time Frame: Cycle 2; each cycle is 21 days (up to 42 days)
Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Duration of Response (DOR) as Assessed by investigators
Time Frame: Cycle 2; each cycle is 21 days (up to 42 days)
Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Progression-free Survival (PFS) as Assessed by investigators
Time Frame: Cycle 2; each cycle is 21 days (up to 42 days)
Cycle 2; each cycle is 21 days (up to 42 days)
Part 1:Overall Survival (OS).
Time Frame: Up to approximately 60 months
Up to approximately 60 months
Part 2:Overall Survival (OS)
Time Frame: Up to approximately 60 months
Up to approximately 60 months
Part 2:Progression-free Survival (PFS) as Assessed by investigators according to RECIST 1.1.
Time Frame: up to 24 months
up to 24 months
Part 2:Objective Response Rate (ORR) as Assessed by investigators and BICR according to RECIST 1.1
Time Frame: up to 24 months
up to 24 months
Part 2:Duration of Response (DOR) as Assessed by investigators and BICR according to RECIST 1.1
Time Frame: up to 24 months
up to 24 months
Part 2:Disease Control Rate(DCR) as Assessed by investigators and BICR according to RECIST 1.1
Time Frame: up to 24 months
up to 24 months
Part 2:Number of Participants With Adverse Events and Serious Adverse Event as Assessed by CTCAE v5.0.
Time Frame: up to 24 months
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2021

Primary Completion (ANTICIPATED)

December 15, 2022

Study Completion (ANTICIPATED)

October 15, 2023

Study Registration Dates

First Submitted

November 5, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (ACTUAL)

November 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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