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)

NCT ID: NCT04203485

Last Updated: 2020-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 762 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2022-05-31

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.

Conditions

PD-L1 Positive Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Camrelizumab 200mg + Apatinib Mesylate 250mg

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

Group Type: EXPERIMENTAL

Camrelizumab 200mg

Intervention Type: BIOLOGICAL

Camrelizumab 200mg q2w ivgtt

Apatinib Mesylate 250mg

Intervention Type: DRUG

Apatinib Mesylate 250mg po qd

Camrelizumab 200mg

Camrelizumab 200mg q2w ivgtt

Group Type: EXPERIMENTAL

Camrelizumab 200mg

Intervention Type: BIOLOGICAL

Camrelizumab 200mg q2w ivgtt

Pemetrexed/Paclitaxel injection+ Carboplatin

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

Group Type: ACTIVE_COMPARATOR

Pemetrexed disodium for injection

Intervention Type: DRUG

Pemetrexed disodium for injection 500 mg/m2 q3w

Paclitaxel injection

Intervention Type: DRUG

Paclitaxel injection 175 mg/m2 q3w

Carboplatin

Intervention Type: DRUG

Carboplatin AUC 5 mg/mL/min q3w

Interventions

Camrelizumab 200mg

Camrelizumab 200mg q2w ivgtt

Intervention Type: BIOLOGICAL

Apatinib Mesylate 250mg

Apatinib Mesylate 250mg po qd

Intervention Type: DRUG

Pemetrexed disodium for injection

Pemetrexed disodium for injection 500 mg/m2 q3w

Intervention Type: DRUG

Paclitaxel injection

Paclitaxel injection 175 mg/m2 q3w

Intervention Type: DRUG

Carboplatin

Carboplatin AUC 5 mg/mL/min q3w

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Quanren Wang, PhD

Role: CONTACT

wangquanren@hrglobe.cn

18036618570

Weixia Li, Master

Role: CONTACT

liweixia@hrglobe.cn

15005136260

References

Zhou C, Wang Y, Zhao J, Chen G, Liu Z, Gu K, Huang M, He J, Chen J, Ma Z, Feng J, Shi J, Yu X, Cheng Y, Yao Y, Chen Y, Guo R, Lin X, Wang Z, Gao G, Wang Q, Li W, Yang X, Wu L, Zhang J, Ren S. Efficacy and Biomarker Analysis of Camrelizumab in Combination with Apatinib in Patients with Advanced Nonsquamous NSCLC Previously Treated with Chemotherapy. Clin Cancer Res. 2021 Mar 1;27(5):1296-1304. doi: 10.1158/1078-0432.CCR-20-3136. Epub 2020 Dec 15.

Reference Type: DERIVED

PMID: 33323401 (View on PubMed)

Other Identifiers

SHR-1210-III-315

Identifier Type: -

Identifier Source: org_study_id