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Lung NeoplasmsPhase 2NCT04425135

Camrelizumab Combined With Apatinib Mesylate and Standard Chemotherapy (Pemetrixed + Carboplatin) in Patients With Tyrosine Kinase Inhibitor Failure in ALK-positive Advanced NSCLC

A Phase 2 study testing Camrelizumab, Apatinib and Pemetrixed in people with Lung Neoplasms, run by The First Affiliated Hospital of Xiamen University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 study is a phase II single-arm clinical study.The purpose of this study was to evaluate the efficacy and safety of carrelizumab combined with apatinib mesylate and standard chemotherapy (pemetrexed plus carboplatin) in patients with advanced non-squamous and non-small cell lung cancer who have failed tyrosine… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lung Neoplasms
What is being tested?
Camrelizumab, Apatinib and Pemetrixed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
No sites listed yet
Study dates
Jul 2020to Jan 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 - 75 year，male or female；
  • Subjects with histologically or cytologically confirmed advanced non-squamous non-small cell lung cancer, imaging stage IIIb~IV；
  • ALK fusion gene is positive and meets the following conditions:
  • First-line treatment failure after previous second-generation ALK-TKI (including but not limited to Aletinib, Ceritinib, Brigatinib, and x-396);
  • Previous first-generation AlK-TKI (crizotinib) and second-generation ALK-TKI (including but not limited to Aletinib, Ceritinib, Brigatinib, and x-396) failed.
  • Patients with at least one evaluable or measurable lesions as per RECIST version 1.1；
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  • Patients who have not previously received systematic chemotherapy for advanced lung cancer .Can also be enrolled if you have previously received Neoadjuvant or adjuvant therapy；
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；
  • Survival expectation ≥ 3 months;
  • Women of childbearing age must have a serum pregnancy study within 2 weeks prior to the first dose and the results are negative. Female subjects of childbearing age and partners who are women of childbearing age must be contraceptive during the study period and within 180 days after the last administration of the study drug;
  • The laboratory test value of the patient before medication should meet the following standards:
  • Routine blood：WBC≥3.0 × 109/L；ANC≥1.5 × 109/L；PLT≥90 × 109/L；HGB≥9.0 g/dL；
  • Liver function：TBIL≤1.5 × ULN，AST≤2.5 × ULN，ALT≤2.5 × ULN（Subjects with liver metastasis，AST≤5× ULN，ALT≤5 × ULN）；
  • Renal function：Cr≤1.5 × ULN or CrCl ≥50 mL/min；
  • Blood coagulation function：INR≤1.5，APTT≤1.5 ×ULN ；
  • Subjects voluntarily joined the study, signed informed consent, good compliance, and followed up;

Who cannot join

  • Tumor histology or cytology pathology confirmed that the components of small cell lung cancer or squamous cell carcinoma were more than 10%；
  • Previously received any T cell costimulation or immunological checkpoint treatment, including but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other T cell-targeting drugs；
  • An active autoimmune disease requiring systemic treatment (such as the use of disease-alleviating drugs, corticosteroids or immunosuppressants) occurred within 2 years prior to the first administration.Alternative therapies (such as thyroxine, insulin or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic;
  • Interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction；
  • Previous or current history of cancer other than NSCLC, except for non-melanoma skin cancer, in-situ cervical cancer or other cancers that have received curable treatment and have shown no signs of recurrence for at least 5 years；
  • Has not fully recovered from toxicity and/or complications from any intervention prior to initiation of treatment (i.e., ≤ grade 1 or level required at baseline, excluding fatigue or hair loss);
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  • Have a tendency to hereditary bleeding or coagulopathy. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above；
  • Patients with clear or suspected brain metastases. Patients with a history of brain metastases （must be completed and patients who are no longer in need of corticosteroid therapy） can be enrolled; for patients with asymptomatic, lesions ≤ 3 and single less than 10 mm, who is determined by the investigator whether or not to enroll ;
  • There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of NYHA class 2 or higher (2) unstable angina (3) myocardial infarction within 24 weeks (4) clinical need for treatment or Interventional supraventricular or ventricular arrhythmia；
  • Uncontrolled hypertension after treatment (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90mmHg), with a history of hypertensive crisis or hypertensive encephalopathy;Uncontrolled hyperglycemia after treatment (fasting glucose >8.9mmol/L);
  • There is a clinically uncontrollable third interstitial fluid (such as pleural effusion/pericardial effusion, patients who do not need drainage or stop drainage for 3 days without significant increase in effusion can be enrolled)；
  • Imaging (CT or MRI) shows that the tumor invades the large blood vessels or the investigator judges that the tumor is highly likely to invade the important blood vessels during the follow-up study and cause fatal bleeding.
  • Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation and bone marrow transplantation；
  • Active hepatitis B (positive detection of hepatitis B virus surface antigen [HBsAg] in the screening period, and detection of HBV-DNA detection value higher than the upper limit of the normal value of the laboratory in the research center) or hepatitis C (in the screening period, hepatitis C virus surface antibody [ HCsAb] positive, HCV-RNA positive)；
  • Subjects who have received or will receive live vaccine within 30 days of the first treatment；
  • Subjects who simultaneously applied NMPA standard modern Traditional Chinese medicine preparation against lung cancer and immunomodulator;
  • Allergic reactions to test drugs for this application；
  • The investigator determined that the subject had other factors that might lead to the termination of the study.

Trial locations and contacts

No sites are listed yet.

Jingxun Wu, doctor contact

15160085395

Jingxun_wu@163.com

About this study

Official title: Phase II Single-arm Clinical Study of Camrelizumab Combined With Apatinib Mesylate and Standard Chemotherapy (Pemetrixed +Carboplatin) in Patients With Tyrosine Kinase Inhibitor Failure in ALK-positive Advanced NSCLC

This study is a phase II single-arm clinical study.The purpose of this study was to evaluate the efficacy and safety of carrelizumab combined with apatinib mesylate and standard chemotherapy (pemetrexed plus carboplatin) in patients with advanced non-squamous and non-small cell lung cancer who have failed tyrosine kinase inhibitor therapy and are ALK-positive.

Conditions
Lung Neoplasms
Being tested
Camrelizumab, Apatinib, Pemetrixed, Carboplatin
Medical subject headings
Lung Neoplasms

What participants receive

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

Study groups in NCT04425135
Study groupRoleWhat they receive
Camrelizumab +apatinib mesylate+Pemetrixed + CarboplatinExperimentalCamrelizumab combined with apatinib mesylate,Pemetrixed and Carboplatin in the treatment（4-6 cycle）of effective (CR, PR, SD) patients continued to be treated with Camrelizumab combined with apadine mesylate until PD, toxicity intolerance, and other reasons that the researcher thinks need to stop the research treatment.
Receives: Drug: Camrelizumab; Drug: Apatinib; Drug: Pemetrixed; Drug: Carboplatin

What is being measured

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

  1. Objective response rate (ORR)

    ORR, determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.

    Measured: up to approximately 1 year

Secondary outcomes (3)

  1. Progression-Free Survival (PFS)

    PFS, defined as the time from treatment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.

    Measured: up to approximately 1 year

  2. Disease Control Rate (DCR)

    Determined using RECIST v1.1 criteria

    Measured: up to approximately 1 year

  3. Overall Survival Rate at 1-year (OSR)

    Measured: up to approximately 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 posted11 Jun 2020
  2. Study startJul 2020 (estimated)
  3. Primary completionJan 2023 (estimated)
  4. Study completionJan 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
59 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04425135
Sponsor's protocol ID
OBU-ALKNSCLC-IIT-SHR1210-APA-C
Status last verified
Jun 2020
First submitted
8 Jun 2020
Last updated
11 Jun 2020
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 2 study testing Camrelizumab, Apatinib and Pemetrixed in people with Lung Neoplasms, run by The First Affiliated Hospital of Xiamen University.

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 16 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 11 Jun 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 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 Jingxun Wu, doctor (15160085395, Jingxun_wu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: up to approximately 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 NCT04425135.

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 11 Jun 2020.

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