Clinical Trials /

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)

NCT04203485

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: 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)
  • 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

Clinical Trial IDs

  • ORG STUDY ID: SHR-1210-III-315
  • NCT ID: NCT04203485

Conditions

  • PD-L1 Positive Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
Camrelizumab 200mgCamrelizumab 200mg + Apatinib Mesylate 250mg
Apatinib Mesylate 250mgCamrelizumab 200mg + Apatinib Mesylate 250mg
Pemetrexed disodium for injectionPemetrexed/Paclitaxel injection+ Carboplatin
Paclitaxel injectionPemetrexed/Paclitaxel injection+ Carboplatin
CarboplatinPemetrexed/Paclitaxel injection+ Carboplatin

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Camrelizumab 200mg + Apatinib Mesylate 250mgExperimentalCamrelizumab 200mg q2w ivgtt+ Apatinib Mesylate 250mg once daily po qd
  • Camrelizumab 200mg
  • Apatinib Mesylate 250mg
Camrelizumab 200mgExperimentalCamrelizumab 200mg q2w ivgtt
  • Camrelizumab 200mg
Pemetrexed/Paclitaxel injection+ CarboplatinActive ComparatorFor non-squamous NSCLC: Pemetrexed disodium for injection + Carboplatin; For squamous NSCLC: Paclitaxel injection + Carboplatin
  • Pemetrexed disodium for injection
  • Paclitaxel injection
  • Carboplatin

Eligibility Criteria

        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.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS) assessed by Independent review committee (IRC)
Time Frame:up to 2 years
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:PFS assessed by investigator
Time Frame:up to 2 years
Safety Issue:
Description:Progression-Free-Survival
Measure:Objective Response Rate
Time Frame:At the time point of every 6 weeks,up to 2 years
Safety Issue:
Description:Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points
Measure:Disease Control Rate
Time Frame:At the time point of every 6 weeks,up to 2 years
Safety Issue:
Description:Disease Control Rate, determined using RECIST v1.1 criteria
Measure:Duration of Response
Time Frame:Up to 2 years
Safety Issue:
Description:Duration of Response, determined using RECIST v1.1 criteria
Measure:Time to Treatment Failure
Time Frame:Up to 2 years
Safety Issue:
Description:Time to Treatment Failure, defined as the time from randomization to treatment discontinuation.
Measure:Adverse Events and Serious Adverse Events
Time Frame:from the first drug administration to within 90 days for the last Camrelizumab dose
Safety Issue:
Description:Adverse Events and Serious Adverse Events

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Jiangsu HengRui Medicine Co., Ltd.

Last Updated

December 16, 2019