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)

Hengrui Medicine

Status and phase: Unknown; Phase 3

Conditions: PD-L1 Positive Non-small Cell Lung Cancer

Treatments: Drug: Carboplatin; Biological: Camrelizumab 200mg; Drug: Paclitaxel injection; Drug: Apatinib Mesylate 250mg; Drug: Pemetrexed disodium for injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04203485

SHR-1210-III-315

Details and patient eligibility

About

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.

Enrollment: 762 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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762 participants in 3 patient groups

Camrelizumab 200mg + Apatinib Mesylate 250mg

Experimental group

Description:

Camrelizumab 200mg q2w ivgtt+ Apatinib Mesylate 250mg once daily po qd

Treatment:

Drug: Apatinib Mesylate 250mg

Biological: Camrelizumab 200mg

Camrelizumab 200mg

Experimental group

Description:

Camrelizumab 200mg q2w ivgtt

Treatment:

Biological: Camrelizumab 200mg

Pemetrexed/Paclitaxel injection+ Carboplatin

Active Comparator group

Description:

For non-squamous NSCLC: Pemetrexed disodium for injection + Carboplatin; For squamous NSCLC: Paclitaxel injection + Carboplatin

Treatment:

Drug: Pemetrexed disodium for injection

Drug: Paclitaxel injection

Drug: Carboplatin