Chemotherapy Combines With Bevacizumab and PD-1 Inhibitor in Non-squamous NSCLC

  • STATUS
    Recruiting
  • End date
    Jul 1, 2024
  • participants needed
    117
  • sponsor
    Qingdao Central Hospital
Updated on 10 March 2022

Summary

In recent years, immunotherapy has emerged as a form of treatment that can lead to robust responses in a subset of patients. PD-1 inhibitor plus chemotherapy showed prolonged survival in NSCLC by the study of KEYNOTE 024, KEYNOTE 189 etc. Thus, this study combines immunotherapeutic agent PD-1 inhibitor with an ant-angiogenic agent, bevacizumab, and double platinum therapy (carboplatin/cisplatin and pemetrexed).

Details
Condition PFS, OS
Treatment PD-1 inhibitor, Bevacizumab, Carboplatin, Cisplatin, Pemtrexed
Clinical Study IdentifierNCT05267366
SponsorQingdao Central Hospital
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

• Must have histologically or cytologically confirmed stage IV non-squamous non-small cell lung cancer
Must have not harbor an EGFR mutation in exon 19 or exon 21, or without an ALK or ROS1 rearrangement
Must have measurable disease by CT or MRI, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v 1.1
Age > 18 years
ECOG performance status of 0 or 1, or 2
Must have normal organ and marrow function as defined below. The use of G-CSF should follow standard recommendations and physician discretion. If blood transfusion is performed for achieving hemoglobin levels, the levels should stay at ≥ 9.0 mg/ml for at least a week after transfusion
Absolute neutrophil count > 1,500/mcL Hemoglobin ≥ 9.0 mg/ml Platelets > 100,000/mcL Total
bilirubin ≤1.5 X institutional upper limit of normal (ULN) AST/ALT (SGOT/SGPT) < 3 times
institutional normal limits, or up to 5 times institutional normal limits if the patient
has liver metastases Creatinine OR Creatinine clearance ≤1.5 X ULN, OR > 40 Ml/min/1.73 m2
for patients with creatinine levels above institutional normal as per Cockcroft-Gault
formula International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless
subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range
of intended use of anticoagulants Activated Partial Thromboplastin Time (aPTT) <1.5 X ULN
unless subject is receiving anticoagulant therapy as long as PT or PTT is within
therapeutic range of intended use of anticoagulants Thyroid stimulating hormone (TSH)
Within normal limits a
a: If TSH is not within normal limits at baseline, the subject will still be eligible if
total T3 or free T4 are within normal limits
Full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral
anticoagulant or low molecular weight heparin (LMWH). If receiving warfarin, the
patient must have an INR ≤3.0. For heparin and LMWH there should be no clinically
significant active bleeding (with no bleeding within 14 days prior to first dose of
protocol therapy) or pathological condition present that carries a high risk of
bleeding (for example, tumor involving major vessels or known varices)
Ability to understand and willingness to sign a written informed consent and HIPAA
consent document
A biopsy, either core, cell block from FNA or cell block from surgical resection, must
be available for the study. If the sample is not adequate, the patient must agree to
provide a fresh biopsy specimen before the start of treatment. Any available archival
tissue will also be collected. While a biopsy sample must be adequate and available
for the study, an inadequate tissue sample would not be explicitly exclusionary and
further discussion with the sponsor is allowed to assess the eligibility of the
patient for the trial if, for clinical or other reasons, a new biopsy sample cannot be
obtained
Urinary protein must be ≤1+ on dipstick or routine urinalysis (UA; if urine dipstick
or routine analysis is ≥2+, a 24 hour urine collection for protein must demonstrate
<1000 mg of protein in 24 hours to allow participation in the protocol)

Exclusion Criteria

Received prior therapies targeting PD-1, PD-L1, CTLA-4 or other immune checkpoints
Received prior platinum-based chemotherapy for advanced disease
Patients who have received prior systemic anti-vascular therapy (e.g
bevacizumab and small molecule VEGFR inhibitors) for advanced disease (Cohort 2)
Treatment with any approved systemic anti-cancer therapy or systemic
immune-stimulatory agents (including but not limited to interferons, interleukin
IL-, and tumor necrosis factor) within 28 days prior to initiation of study
treatment
Clinically uncontrolled pleural effusion or ascites that requires pleurocentesis
or abdominal tapping for drainage within 2 weeks prior to initiation of study
treatment
Active leptomeningeal disease or uncontrolled brain metastasis
History of allergic reactions to any study drugs
CrCl < 45 mL/min
Patients with active viral hepatitis that requires treatment
Active autoimmune diseases that requires treatment and may affect study treatment
estimated by investigator
Any condition that required systemic treatment with either corticosteroids or any
other immunosuppressive medication that may affect study treatment estimated by
investigator
Severe chronic or active infections requiring systemic antibacterial, antifungal
or antiviral therapy
History of hemoptysis, i.e., coughing up at least one-half teaspoon of fresh
blood, within 3 months prior to enrollment. (Cohort 2)
Imaging shows tumor invasion of a large vessel (e.g., pulmonary artery or
superior vena cava) that the investigator determines is at risk for bleeding
(Cohort 2)
Had minor surgical procedures, such as tube placement, within 48 hours prior to
first bevacizumab treatment. (Cohort 2)
Recently treated with a full dose oral or parenteral anticoagulant or
thrombolytic agent. Prophylactic using anticoagulants is allowed. (Cohort 2)
History or test results indicating an inherited bleeding tendency or coagulation
disorder that may increase the risk of bleeding (cohort 2)
uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic
blood pressure >100 mmHg) (cohort 2)
Clinically meaningful (e.g., active) cardiovascular disease that, in the judgment
of the investigator, is intolerant to bevacizumab therapy (cohort 2)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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