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Camrelizumab Combined With Apatinib Mesylate or Camrelizumab Alone for First-line Treatment in Subjects With Programmed Death Ligand 1 (PD-L1) Positive Relapsed or Advanced Non-small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04203485
Recruitment Status : Not yet recruiting
First Posted : December 18, 2019
Last Update Posted : May 8, 2020
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
The study is being conducted to evaluate the efficacy and safety of Camrelizumab (200mg,q2w) combined with Apatinib(250mg qd) in subjects with PD-L1 positive relapsed or advanced non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
PD-L1 Positive Non-small Cell Lung Cancer Biological: Camrelizumab 200mg Drug: Apatinib Mesylate 250mg Drug: Pemetrexed disodium for injection Drug: Paclitaxel injection Drug: Carboplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 762 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Controlled, Multicenter Phase III Study of Camrelizumab Combined With Apatinib Mesylate or Camrelizumab Alone Versus Platinum-based Chemotherapy for First-line Treatment in Subjects With PD-L1 Positive Relapsed or Advanced NSCLC
Estimated Study Start Date : June 15, 2020
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Camrelizumab 200mg + Apatinib Mesylate 250mg
Camrelizumab 200mg q2w ivgtt+ Apatinib Mesylate 250mg once daily po qd
Biological: Camrelizumab 200mg
Camrelizumab 200mg q2w ivgtt

Drug: Apatinib Mesylate 250mg
Apatinib Mesylate 250mg po qd

Experimental: Camrelizumab 200mg
Camrelizumab 200mg q2w ivgtt
Biological: Camrelizumab 200mg
Camrelizumab 200mg q2w ivgtt

Active Comparator: Pemetrexed/Paclitaxel injection+ Carboplatin
For non-squamous NSCLC: Pemetrexed disodium for injection + Carboplatin; For squamous NSCLC: Paclitaxel injection + Carboplatin
Drug: Pemetrexed disodium for injection
Pemetrexed disodium for injection 500 mg/m2 q3w

Drug: Paclitaxel injection
Paclitaxel injection 175 mg/m2 q3w

Drug: Carboplatin
Carboplatin AUC 5 mg/mL/min q3w

Primary Outcome Measures :
  1. Progression Free Survival (PFS) assessed by Independent review committee (IRC) [ Time Frame: up to 2 years ]
    Progression Free Survival, defined as the time from randomization to the first occurrence of disease progression as determined by IRC with use of Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death from any cause, whichever occurs first.

  2. Overall survival [ Time Frame: up to 2 years ]
    Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up

Secondary Outcome Measures :
  1. PFS assessed by investigator [ Time Frame: up to 2 years ]

  2. Objective Response Rate [ Time Frame: At the time point of every 6 weeks,up to 2 years ]
    Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points

  3. Disease Control Rate [ Time Frame: At the time point of every 6 weeks,up to 2 years ]
    Disease Control Rate, determined using RECIST v1.1 criteria

  4. Duration of Response [ Time Frame: Up to 2 years ]
    Duration of Response, determined using RECIST v1.1 criteria

  5. Time to Treatment Failure [ Time Frame: Up to 2 years ]
    Time to Treatment Failure, defined as the time from randomization to treatment discontinuation.

  6. Adverse Events and Serious Adverse Events [ Time Frame: from the first drug administration to within 90 days for the last Camrelizumab dose ]
    Adverse Events and Serious Adverse Events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects who have recurrent or advanced (Stage IIIB-IV) non-small cell lung cancer confirmed by histology or cytology.
  2. No prior systemic treatment. Subjects who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 6 months from randomization since the last chemotherapy cycle.
  3. Subjects should not have a previously detected activating Epidermal Growth Factor Receptor (EFGR) mutation or Anaplastic Lymphoma Kinase (ALK) fusion oncogene.
  4. Subjects must have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria;
  5. Freshly acquired samples or archived specimens within 6 months before randomization must be provided.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Exclusion Criteria:

  1. Radiologically confirmed central squamous cell carcinoma.
  2. Untreated central nervous system metastases (such as brain or meningeal metastases).
  3. Pleural effusion, pericardial effusion, or ascites with clinical symptoms that need drainage
  4. Past or present with idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, tissue pneumonia (eg bronchitis, occlusive vasculitis), drug-induced pneumonia, active pneumonia during CT screening, or objective evidence of severe impairment of lung function
  5. Subjects with an active, known or suspected autoimmune disease. Patients with type I diabetes who are receiving a stable dose of insulin, hypothyroidism who only needs hormone replacement therapy, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and do not have acute deterioration within 1 year before the screening period, are allowed.
  6. Subjects with suspected active tuberculosis should be examined for chest X-rays, sputum, and ruled out by clinical signs and symptoms.
  7. Uncontrolled Cardiac Symptoms or Diseases.
  8. Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
  9. Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first 6 months of randomization.
  10. Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-cytotoxic T lymphocyte antigen-4 monoclonal antibody, or vascular endothelial growth factor receptor (VEGFR) small molecule inhibitor therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04203485

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Contact: Quanren Wang, PhD 18036618570
Contact: Weixia Li, Master 15005136260

Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd. Identifier: NCT04203485    
Other Study ID Numbers: SHR-1210-III-315
First Posted: December 18, 2019    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors