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AzTrials

PD-L1 Positive Non-small Cell Lung CancerPhase 3NCT04203485

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)

A Phase 3 study testing Camrelizumab 200mg, Apatinib Mesylate 250mg and Pemetrexed disodium for injection in people with PD-L1 Positive Non-small Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Camrelizumab 200mg, Apatinib Mesylate 250mg and Pemetrexed disodium for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
762 participants
Where
No sites listed yet
Study dates
15 Jun 2020to 31 May 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

No sites are listed yet.

Quanren Wang, PhD contact

18036618570

wangquanren@hrglobe.cn

Weixia Li, Master contact

15005136260

liweixia@hrglobe.cn

About this study

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

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.

Being tested
Camrelizumab 200mg, Apatinib Mesylate 250mg, Pemetrexed disodium for injection, Paclitaxel injection, Carboplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Camrelizumab 200mgBiological

    Camrelizumab 200mg q2w ivgtt

  • Apatinib Mesylate 250mgDrug

    Apatinib Mesylate 250mg po qd

  • Pemetrexed disodium for injectionDrug

    Pemetrexed disodium for injection 500 mg/m2 q3w

  • Paclitaxel injectionDrug

    Paclitaxel injection 175 mg/m2 q3w

  • CarboplatinDrug

    Carboplatin AUC 5 mg/mL/min q3w

Study groups in NCT04203485
Study groupRoleWhat they receive
Camrelizumab 200mg + Apatinib Mesylate 250mgExperimentalCamrelizumab 200mg q2w ivgtt+ Apatinib Mesylate 250mg once daily po qd
Receives: Biological: Camrelizumab 200mg; Drug: Apatinib Mesylate 250mg
Camrelizumab 200mgExperimentalCamrelizumab 200mg q2w ivgtt
Receives: Biological: Camrelizumab 200mg
Pemetrexed/Paclitaxel injection+ CarboplatinActive comparatorFor non-squamous NSCLC: Pemetrexed disodium for injection + Carboplatin; For squamous NSCLC: Paclitaxel injection + Carboplatin
Receives: Drug: Pemetrexed disodium for injection; Drug: Paclitaxel injection; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 2 years

  2. Overall survival

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

    Measured: up to 2 years

Secondary outcomes (6)

  1. PFS assessed by investigator

    Progression-Free-Survival

    Measured: up to 2 years

  2. Objective Response Rate

    Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points

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

  3. Disease Control Rate

    Disease Control Rate, determined using RECIST v1.1 criteria

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

  4. Duration of Response

    Duration of Response, determined using RECIST v1.1 criteria

    Measured: Up to 2 years

  5. Time to Treatment Failure

    Time to Treatment Failure, defined as the time from randomization to treatment discontinuation.

    Measured: Up to 2 years

  6. Adverse Events and Serious Adverse Events

    Adverse Events and Serious Adverse Events

    Measured: from the first drug administration to within 90 days for the last Camrelizumab dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2019
  2. Study start15 Jun 2020 (estimated)
  3. Primary completion31 Mar 2022 (estimated)
  4. Study completion31 May 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
762 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04203485
Sponsor's protocol ID
SHR-1210-III-315
Status last verified
May 2020
First submitted
13 Dec 2019
Last updated
8 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33323401

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Camrelizumab 200mg, Apatinib Mesylate 250mg and Pemetrexed disodium for injection in people with PD-L1 Positive Non-small Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Quanren Wang, PhD (18036618570, wangquanren@hrglobe.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) assessed by Independent review committee (IRC) (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04203485, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.

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