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Locally Advanced Non-Small Cell Lung CancerPhase 2NCT04749394

A Study of Camrelizumab Plus Apatinib as Consolidation Therapy in Non-Small Cell Lung Cancer Patients Treated With Chemoradiotherapy

A Phase 2 study testing Camrelizumab, PD-1 monoclonal antibody and Apatinib, VEGFR2 antibody in people with Locally Advanced Non-Small Cell Lung Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a phase II, open-Label, multi-centre study to determine the efficacy and safety of Camrelizumab plus apatinib in participants with unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), who have not progressed following platinum-based concurrent chemoradiation therapy (cCRT) or sequential chemoradiation… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Camrelizumab, PD-1 monoclonal antibody and Apatinib, VEGFR2 antibody
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteChina
Study dates
17 Mar 2021to Jun 2025
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged ≥18 years, male and female are not limited;
  • Patients with ECOG score of 0-1;
  • Life expectancy ≥12 weeks;
  • Patients must have histologically or cytologicallyproved NSCLC, and present with locally advanced, unresectable Stage III disease(according to 8th AJCC/UICC Classification);
  • Receipt of concurrent or sequential chemoradiation therapy which must have been completed within 42 days prior to first dose administration of the study; Consolidation chemotherapy is not permitted.
  • No progression following definitive, platinum-based, concurrent or sequential chemoradiation therapy;
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  • Subject with prior anti-cancer treatment can only be enrolled when all toxicities of prior anti-cancer treatment has recovered to baseline or ≤ Grade 1, except for hearing loss, alopecia and fatigue. (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] V5.0);
  • No prior exposure to any anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-VEGF treatments, as well as therapeutic anticancer vaccines;
  • Agreement to provide tumor histological specimens required for this study;
  • Adequate organ and marrow function required;
  • Fertile female were required to have a negative serum or urine pregnancy test within 72 days before the start dose of study medication; If female of childbearing potential, is willing to use adequate contraception for the course of the study through 90 days after the last dose of study medication; if male with a female partner(s) of child-bearing potential, he must agree to use adequate contraception starting with the first dose of study medication through 90 days after the last dose of study medication or have been surgically sterilized;
  • Provision of signed ICF.

Who cannot join

  • Mixed small cell lung cancer histology;
  • Disease progression after concurrent/sequential chemoradiotherapy;
  • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of treatment;
  • Receipt of live attenuated vaccine within 28 days prior to the first dose of treatment;
  • Previous enrolment of another study and receiving any study drug within 28 days prior to the first dose of treatment;
  • Patients with ≥Grade 2 pneumonitis from the prior anti-cancerchemoradiation therapy;
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  • Imaging (CT or MRI) shows the tumor invading large vessels or blurring the boundary with vessels;
  • History of organ transplant or allogeneic hematopoietic stem cell transplantation;
  • Patients with any active autoimmune disease or history of autoimmune disease;
  • Patients with innate or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection;
  • Uuntreated active hepatitis B or, hepatitis C or active tuberculosis or currently receiving anti-tuberculosis treatment co-infection with hepatitis B and hepatitis C;
  • Subjects receiving systemic treatment with corticosteroids (>10mg/day of prednisone or its equivalent) or other immunosuppressants within 14 days prior to the first administration;
  • History of another primary malignancy within 5 years prior to enrollment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study;
  • Pulmonary function test: FEV1< 1.2L or DLCO < 50% of predicted value;
  • Patients with cardiac insufficiencyheart diseases including: 1) NYHA III-IV; 2）Acute coronary syndrome; 3) Supraventricular or ventricular arrhythmias requiring clinical intervention; 4) Pericardial and myocardial diseases; 5) Echocardiography indicates that the left ventricular ejection fraction (LVEF) is < 50%;
  • Patients with uncontrollable hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, despite the best drug treatment);
  • Patients who have had arteriovenous thrombosis events within 6 months, such as cerebrovascular accident (including cerebral embolism, deep vein thrombosis, pulmonary embolismcerebral hemorrhage, cerebral infarction, transient ischemic attack, etc.);
  • Patients with hemoptysis, active bleeding, ulcer, intestinal perforation and intestinal obstruction within 3 months before administration;
  • Significant hemoptysis symptoms or daily amount of hemoptysis up to 2.5mL or more within 30 days before the first administration;
  • Known hereditary or acquired bleeding and thrombosis tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.);
  • Routine urine test indicated that urine protein was ≥ (++), or 24-hour urine protein was ≥ 1g, or severe liver and kidney dysfunction;
  • Patients with severe infection or fever of unknown origin > 38.5 degrees C within 24 weeks before medication;
  • Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures;
  • Known allergies, hypersensitivity, or intolerance to camrelizumab or its excipients, apatinib and chemotherapy drugs;
  • Any conditions, judged by investigators, that may impair the subject or cause the subject to be unable to meet or perform the study requirements.

Trial locations and contacts

1 site in 1 country.

Zhouguang Hui contact

18611876792

drhuizg@163.com

Yirui Zhai contact

18610168510

januarywind@163.com

China1 site, 1 recruiting

  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, 100021

    Zhouguang Hui, M.D., 8610-87787230, drhuizg@163.com

    Zhouguang Hui, M.D.

    Recruiting

Other trials in China

About this study

Official title: A Phase II, Open-Label, Multi-Centre Study of Camrelizumab Plus Apatinib As Consolidation Therapy in Patients With Locally Advanced, Unresectable NSCLC, Who Have Not Progressed Following Definitive, Platinum-Based Chemoradiation Therapy

This is a phase II, open-Label, multi-centre study to determine the efficacy and safety of Camrelizumab plus apatinib in participants with unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), who have not progressed following platinum-based concurrent chemoradiation therapy (cCRT) or sequential chemoradiation therapy (sCRT). This study will be conducted in China mainland.

Read the detailed description

This trial will evaluate the efficacy and safety of camrelizumab plus apatinib in participants with unresectable stage III NSCLC who have not progressed following definitive, platinum-based cCRT or sCRT. The primary endpoint is progression free survival (PFS) in the intent-to-treat (ITT) population. The secondary endpoints are as follows: 1) Overall survival (OS); 2) 1, 2, 3-year OS rates; 3) PFS rates at 12-monthand 18-month; 4) Objective response rate (ORR), 5) Duration of response (DoR); 6) Time to death or distant metastasis (TTDM); 7) Adverse effects (AEs) and severe adverse effects (SAEs) ;8) Quality of life (QoL).Exploratory objective is to explore potential biomarkers associated with efficacy.

Being tested
Camrelizumab, PD-1 monoclonal antibody, Apatinib, VEGFR2 antibody
Keywords
Non-Small Cell Lung Cancer, Programmed cell death 1 (PD-1, PD1), Anti VEGF, Chemoradiotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

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

  • Camrelizumab, PD-1 monoclonal antibodyDrug

    Also called SHR-1210

    Camrelizumab 200mg IV, Q3W, until clinical progression/deterioration or confirmed radiological progression, or up to 1 year.

  • Apatinib, VEGFR2 antibodyDrug

    Also called Apatinib Mesylate

    Apatinib 250mg PO, QD, until clinical progression/deterioration or confirmed radiological progression, or up to 1 year.

Study groups in NCT04749394
Study groupRoleWhat they receive
Experimental ArmExperimentalCamrelizumab plus apatinib as consolidation therapy
Receives: Drug: Camrelizumab, PD-1 monoclonal antibody; Drug: Apatinib, VEGFR2 antibody

What is being measured

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

  1. Progression-free Survival (PFS)

    PFS is determined by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

    Measured: From the first date of treatment until the date of objective disease progression or death (up to maximum 24 months)

Secondary outcomes (10)

  1. Overall Survival (OS)

    OS is defined as the first date of treatment to date of death from any causes.

    Measured: up to approximately 36 months

  2. PFS at 12 months (PFS12)

    PFS will be calculated using Kaplan-Meier product limit methods.

    Measured: up to maximum 12 months

  3. PFS at 18 months (PFS18)

    PFS will be calculated using Kaplan-Meier product limit methods.

    Measured: up to maximum 18 months

  4. OS at 12 months (OS12)

    OS will be calculated using Kaplan-Meier product limit methods.

    Measured: up to maximum 12 months

  5. OS at 24 months (OS24)

    OS will be calculated using Kaplan-Meier product limit methods.

    Measured: up to maximum 24 months

  6. OS at 36 months (OS36)

    OS will be calculated using Kaplan-Meier product limit methods.

    Measured: up to maximum 36 months

  7. Objective response rate (ORR)

    ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by investigator.

    Measured: up to approximately 24 months

  8. Duration of Response (DoR)

    DoR is defined as the first date of treatment to the progression, or the last evaluable assessment in the absence of progression.

    Measured: up to approximately 24 months

  9. TTDM

    TTDM is defined as the first date of treatment to the first date of distant metastasis or death in the absence of distant metastasis.

    Measured: up to approximately 36 months

  10. Number of participants with AEs, SAEs, Treatment-related Adverse Events (TRAEs).

    Measured: From screening (Day -28) till final visit (up to a maximum of 24 months)

Timeline

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

  1. First posted11 Feb 2021
  2. Study start17 Mar 2021
  3. Primary completionJan 2025 (estimated)
  4. Study completionJun 2025 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04749394
Sponsor's protocol ID
NCC004692
Status last verified
Aug 2022
First submitted
5 Feb 2021
Last updated
16 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab, PD-1 monoclonal antibody and Apatinib, VEGFR2 antibody in people with Locally Advanced Non-Small Cell Lung Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.

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 12 inclusion and 25 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 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Zhouguang Hui (18611876792, drhuizg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: From the first date of treatment until the date of objective disease progression or death (up to maximum 24 months)). 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 NCT04749394.

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 16 Aug 2022.

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