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 | Unknown Phase 3 DMC

• 1 other identifier: SHR-1210-III-315
• Study Type: interventional
• Target: 762
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS) assessed by Independent review committee (IRC)

  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.

  up to 2 years

• Overall survival

  Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up

  up to 2 years

Secondary Outcomes (6)

• PFS assessed by investigator

  up to 2 years

• Objective Response Rate

  At the time point of every 6 weeks，up to 2 years

• Disease Control Rate

  At the time point of every 6 weeks，up to 2 years

• Duration of Response

  Up to 2 years

• Time to Treatment Failure

  Up to 2 years

Study Arms (3)

Camrelizumab 200mg + Apatinib Mesylate 250mg

EXPERIMENTAL

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

Biological: Camrelizumab 200mg; Drug: Apatinib Mesylate 250mg

Camrelizumab 200mg

EXPERIMENTAL

Camrelizumab 200mg q2w ivgtt

Biological: Camrelizumab 200mg

Pemetrexed/Paclitaxel injection+ Carboplatin

ACTIVE COMPARATOR

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

Drug: Pemetrexed disodium for injection; Drug: Paclitaxel injection; Drug: Carboplatin

Interventions

Camrelizumab 200mg BIOLOGICAL

Camrelizumab 200mg q2w ivgtt

Camrelizumab 200mg; Camrelizumab 200mg + Apatinib Mesylate 250mg

Apatinib Mesylate 250mg DRUG

Apatinib Mesylate 250mg po qd

Camrelizumab 200mg + Apatinib Mesylate 250mg

Pemetrexed disodium for injection DRUG

Pemetrexed disodium for injection 500 mg/m2 q3w

Pemetrexed/Paclitaxel injection+ Carboplatin

Paclitaxel injection DRUG

Paclitaxel injection 175 mg/m2 q3w

Pemetrexed/Paclitaxel injection+ Carboplatin

Carboplatin DRUG

Carboplatin AUC 5 mg/mL/min q3w

Pemetrexed/Paclitaxel injection+ Carboplatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have recurrent or advanced (Stage IIIB-IV) non-small cell lung cancer confirmed by histology or cytology.
• 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.
• Subjects should not have a previously detected activating Epidermal Growth Factor Receptor (EFGR) mutation or Anaplastic Lymphoma Kinase (ALK) fusion oncogene.
• Subjects must have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria;
• Freshly acquired samples or archived specimens within 6 months before randomization must be provided.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

You may not qualify if:

• Radiologically confirmed central squamous cell carcinoma.
• Untreated central nervous system metastases (such as brain or meningeal metastases).
• Pleural effusion, pericardial effusion, or ascites with clinical symptoms that need drainage
• 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
• 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.
• Subjects with suspected active tuberculosis should be examined for chest X-rays, sputum, and ruled out by clinical signs and symptoms.
• Uncontrolled Cardiac Symptoms or Diseases.
• Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
• 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.
• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Related Publications (1)

• 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.

  PMID: 33323401 DERIVED

MeSH Terms

Interventions

camrelizumab; apatinib; Pemetrexed; Injections; Paclitaxel; Carboplatin

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Drug Administration Routes; Drug Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Central Study Contacts

Quanren Wang, PhD

CONTACT

18036618570; wangquanren@hrglobe.cn

Weixia Li, Master

CONTACT

15005136260; liweixia@hrglobe.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 18, 2019
• Study Start: June 15, 2020
• Primary Completion: March 31, 2022
• Study Completion: May 31, 2022
• Last Updated: May 8, 2020

Record last verified: 2020-05