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Lung NeoplasmPhase 3NCT04490421

Camrelizumab Combined With Apatinib, Etoposide and Cisplatin Treat Small-cell Lung Cancer.

A Phase 3 study testing Camrelizumab combined with Apatinib, Etoposide and Cisplatin in people with Lung Neoplasm and Small Cell Lung Cancer, run by Fuzhou General Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Small cell lung cancer is a highly malignant tumor, and its first-line treatment has not broken through platinum-containing dual-drug chemotherapy in the past 30 years. Because small cell lung cancer has the characteristics of easy resistance after first-line chemotherapy, increased difficulty in treatment after… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Camrelizumab combined with Apatinib, Etoposide and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
1 Aug 2020to 1 Feb 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years old and ≤75 years old, regardless of gender;
  • Extensive-stage small cell lung cancer confirmed by histology or pathology;
  • According to the RECIST V1.1 standard, there is at least one measurable lesion;
  • Patients who have not previously been treated for small cell lung cancer (immune, targeted, chemotherapy, etc.);
  • Eastern Cooperative Oncology Group's physical status score (ECOG PS) 0~1;
  • Expected survival period ≥ 3 months;
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  • Women of childbearing age must undergo a serum pregnancy study within 2 weeks before the first medication, and the result is negative. Female subjects of childbearing age and male subjects whose partners are women of childbearing age must contraception during the study and within 180 days after the last administration of the study drug;
  • The laboratory examination values of patients before medication must meet the following standards:
  • Blood routine: WBC≥3.0 × 109/L；ANC≥1.5 × 109/L；PLT≥100× 109/L；HGB≥9.0 g/dL; Liver function: TBIL≤1.5 × ULN, AST≤2.5 × ULN, ALT≤2.5 × ULN (for subjects with liver metastases, AST≤5×ULN, ALT≤5 × ULN) Renal function: Cr≤1.5 × ULN or CrCl ≥50 mL/min Coagulation function: INR≤1.5, APTT≤1.5 ×ULN
  • The subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.

Who cannot join

  • Active, known or suspected autoimmune diseases;
  • Prior T cell co-stimulation or immunocheckpoint therapy, including but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other T-cell-targeted drugs;
  • Interstitial lung disease, drug-induced pneumonia, radioactive pneumonia requiring steroid treatment or active pneumonia with clinical symptoms or severe pulmonary dysfunction;
  • A past or present history of cancer other than SCLC, except for non-melanoma skin cancer, cervical cancer in situ, or other cancers that have received curative treatment and have not shown signs of recurrence for at least 5 years;
  • Standard treatment for uncontrolled hypertension (blood pressure < 150/90 mmHg)
  • Hereditary bleeding tendency or coagulation dysfunction. There were clinically significant bleeding symptoms or definite bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, and fecal occult blood ++ or above at baseline;
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  • Patients with definite or suspected brain metastases. Patients with a history of brain metastases must have completed treatment and no longer require corticosteroid therapy to be enrolled; For asymptomatic patients with no more than 3 lesions and a single brain transfer less than 10mm, the researcher judged whether they were included or not.
  • Clinical symptoms or diseases of the heart that are not well controlled, such as :heart failure of NYHA2 or above; unstable angina pectoris; myocardial infarction within 24 weeks; clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;
  • The presence of clinically uncontrollable third interstitial effusion (such as pleural effusion/pericardial effusion, patients who do not need drainage or have no significant increase of effusion after 3 days of drainage can be enrolled);
  • Subjects with a history of severe infection within 4 weeks prior to the first administration, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc. Subjects with any active infection were excluded. Lymphatic spread of lung cancer was not excluded.
  • Imaging (CT or MRI) shows that the tumor invades the great vessels or the researchers judge that the tumor is likely to invade the important vessels and cause fatal hemorrhage during the follow-up study;
  • A history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation;
  • Active hepatitis B (defined as hepatitis B virus surface antigen [HBsAg] test positive and hbV-DNA test value higher than the upper limit of normal value in the laboratory of the research center) or Hepatitis C (defined as hepatitis C virus surface antibody [HCsAb] test positive and HCV-RNA positive);
  • Subjects requiring systematic treatment with corticosteroids (>10 mg/ day prednisone or its equivalent) or other immunosuppressive agents within 14 days of the first administration. Adrenal hormone replacement therapy with inhaled or topical corticosteroids and > 10 mg/ day dose of prednisone in the absence of active autoimmune disease;
  • Patients who received oral or intravenous antibiotics within 14 days before treatment;
  • The patient has an allergic reaction to the experimental drug;
  • Subjects who have received or will receive live vaccine within 30 days before the first medication;
  • As determined by the researcher, the subjects have other factors that may lead to the forced termination of the study.

Trial locations and contacts

1 site in 1 country.

Xiong Chen contact

13625082108 ext. +86

zpccx81@163.com

China1 site, 1 recruiting

  • The 900th Hospital of Joint Logistic Support Force

    Fuzhou, Fujian, 350025

    Xiong Chen, 13625082108, zpccx81@163.com

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Prospective Study of Camrelizumab Combined With Apatinib, Etoposide and Cisplatin in First-line Treatment of Extensive Small-cell Lung Cancer.

Small cell lung cancer is a highly malignant tumor, and its first-line treatment has not broken through platinum-containing dual-drug chemotherapy in the past 30 years. Because small cell lung cancer has the characteristics of easy resistance after first-line chemotherapy, increased difficulty in treatment after resistance, and poor efficacy of second-line treatment, how to formulate a plan that can control tumor progression to the greatest extent has become a hot issue in recent research. Recently, immunotherapy and targeted therapy have made breakthrough progress in small cell lung cancer, but its efficacy still needs to be further improved. As immune combined chemotherapy combined with targeted therapy first achieved good results in other tumors, this study aims to explore a longer disease-free survival time and higher overall survival rate of patients with small cell lung cancer through immunotherapy combined with targeted therapy combined with chemotherapy. Program to bring new hope to patients. At the same time, this study will evaluate the safety of the program, explore the prognostic indicators that may exist in the treatment, and provide new inspiration for subsequent patient selection.

Being tested
Camrelizumab combined with Apatinib, Etoposide and Cisplatin
Keywords
Small-cell lung cancer, immunotherapy
Medical subject headings
Lung Neoplasms, Small Cell Lung Carcinoma

What participants receive

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

  • Camrelizumab combined with Apatinib, Etoposide and CisplatinDrug

    Camrelizumab combined with Apatinib, Etoposide and Cisplatin

Study groups in NCT04490421
Study groupRoleWhat they receive
ExperimentalExperimentalExperimental:Camrelizumab combined with Apatinib, Etoposide and Cisplatin
Receives: Drug: Camrelizumab combined with Apatinib, Etoposide and Cisplatin

What is being measured

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

  1. 1-year overall survival rate(1-year OS%)

    1-year OS%, determined by RECIST V1.1 standard which means proportion of outcome events occurring within one year from the start of the trial

    Measured: up to 1-year

Secondary outcomes (4)

  1. progression-free survival(PFS)

    PFS, determined by RECIST V1.1 standard which means the time from the beginning of the organised clinical trial to the onset of tumors (in any aspect) or death due to any reason

    Measured: up to approximately 4-6 months

  2. overall survival(OS)

    OS, determined by RECIST V1.1 standard which means the time from randomization of patients in clinical trials to death due to any cause.

    Measured: up to approximately 18 months

  3. Objective Response Rate(ORR)

    ORR, determined by RECIST V1.1 standard which refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time

    Measured: up to 1-year

  4. disease control rate(DCR)

    DCR, determined by RECIST V1.1 standard which refers to proportion of patients whose tumors have shrunk or stabilized for a certain period of time

    Measured: up to 1-year

Timeline

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

  1. First posted29 Jul 2020
  2. Study start1 Aug 2020
  3. Primary completion1 Aug 2021 (estimated)
  4. Study completion1 Feb 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04490421
Sponsor's protocol ID
OBU-FJ-SCLC-II-005
Status last verified
Jul 2020
First submitted
24 Jul 2020
Last updated
8 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Camrelizumab combined with Apatinib, Etoposide and Cisplatin in people with Lung Neoplasm and Small Cell Lung Cancer, run by Fuzhou General Hospital 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 10 inclusion and 18 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 Feb 2021. 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 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 Xiong Chen (13625082108 ext. +86, zpccx81@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year overall survival rate(1-year OS%) (time frame: up to 1-year). 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 NCT04490421.

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 Feb 2021.

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