Efficacy and Safety Study of Anlotinib With Pembrolizumab in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Non-small Cell Lung Cancer

  • STATUS
    Recruiting
  • days left to enroll
    43
  • participants needed
    49
  • sponsor
    Peking Union Medical College Hospital
Updated on 17 February 2022
systemic therapy
metastasis
progressive disease
pembrolizumab
ROS1
EGFR
cancer chemotherapy
solid tumour
mk-3475
recurrent non-small cell lung cancer
lung carcinoma
secondary malignant neoplasm of liver
proto-oncogene tyrosine-protein kinase ros

Summary

The purpose of this study is to assess the safety and efficacy of Anlotinib (AL3818) combined with pembrolizumab (MK-3475) in treatment-nave adults with no prior systemic therapy for advanced non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.

The primary study hypotheses is that the combination of Anlotinib and pembrolizumab is superior to pembrolizumab alone(historical data) as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

Details
Condition NSCLC
Treatment Pembrolizumab, Anlotinib, oral capsule
Clinical Study IdentifierNCT04164745
SponsorPeking Union Medical College Hospital
Last Modified on17 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

volunteered to join the study, signed the informed consent, had good compliance and cooperated with the follow-up
age: 18 years old
Histologically or cytologically confirmed locally advanced NSCLC(not suitable for or refuse to do radical radiotherapy and chemotherapy)/advanced NSCLC, have not previously received systemic treatment for locally advanced or advanced NSCLC. The completion time of previous neoadjuvant / adjuvant treatment for recurrent subjects should be 6 months
Negative in EGFR,ALK and ROS1(tumor tissue sample results)
Has tumor tissue that demonstrates PD-L1 expression in 1% of tumor cells (TPS1%) as assessed by immunohistochemistry (IHC) 22C3 pharmDx assay at a central laboratory
Diagnosed with advanced or recurrent NSCLC through pathology, with measurable nidus(using RECIST 1.1)
Has a life expectancy of 3 months
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Has adequate organ function
HB90g/L
ANC1.5109/L
PLT100109/L
WBC4.0109/L and 15109/L
ALT and AST1.5ULN(5ULN in patients with liver metastases)
ALP2.5ULN
TBiL1.5ULN
ALB30g/L
TSHULN(If abnormal, T3 and T4 levels should be examined; If T3 and T4 levels are normal, they can be enrolled)
Cr1.5ULNand CrCL60mL/min(Cockcroft-Gault)
The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 4 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 120 days after it

Exclusion Criteria

Has an active autoimmune disease that has required systemic treatment. Replacement therapy is not considered a form of systemic treatment and is allowed
Is receiving systemic steroid therapy within 3 days before the first dose of study treatment
Live vaccines were administered within 4 weeks or possibly during the study
Gene test results of tissue or blood samples confirmed the existence of EGFR, ALK and ROS1 variants
CT or MRI showed that the distance between the tumor focus and the large blood vessel was less than or equal to 5 mm, or there was a large local invasion Blood vessels, or central tumor with high risk of bleeding, or obvious cavitary or necrotic tumor of lung
Has active central nervous system metastasis (subjects who have completed treatment 21 days before randomization and have stable symptoms can be enrolled, but they need to be confirmed by imaging evaluation as no active bleeding symptoms, and have stopped systemic agitation Hormone therapy: dosage > 10mg / day prednisone or other effective hormones
Has received prior therapy with Anlotinib, anti-PD-1(L1) or anti-CTLA-4 agents
Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy
Has significant cardiovascular impairment, such as a history of congestive heart failure greater than New York Heart Association Class II, unstable angina, myocardial infarction within 12 months of the first dose of study treatment, or cardiac arrhythmia associated with hemodynamic instability
Has uncontrolled blood pressure (defined as systolic pressure140 mm Hg or diastolic pressure90 mm Hg)
Has had an allogeneic tissue/solid organ transplant
\. Abnormal coagulation (INR > 1.5 or PT > ULN + 4S or APTT > 1.5 ULN), with
bleeding tendency or undergoing thrombolysis or anticoagulation. Note: on the
premise of INR 1.5, it is allowed to use low-dose heparin (daily dosage for
adults is 6000-12000 U) or low-dose aspirin (daily dosage 100mg) for
prevention purposes
\. Has arterial/venous thrombosis within 6 months, such as cerebrovascular
accidents (including temporary ischemic stoke), deevenous thrombosis, and
pulmonary embolism
\. Has had clinically significant hemoptysis within 3 months before the
study (more than 50ml hemoptysis per day); or clinically significant bleeding
symptoms or clear bleeding tendency (such as gastrointestinal bleeding
bleeding gastric ulcer, Gastrointestinal bleeding, hemorrhagic gastric ulcer
stool occult blood + + or above in baseline, or suffer from vasculitis, etc
\. Urine routine indicates urine protein + +, or confirms 24-hour urine
protein content 1.0g
\. Has congenital or acquired immune deficiency (such as HIV infection), or
active hepatitis
\. Has uncontrolled pleural effusion, pericardial effusion, or ascites
requiring repeated drainage
\. Take major surgical treatments, open biopsy, or get overt traumatic
injury within 28 days before enrollment
\. Has a previous and current history of pulmonary fibrosis, interstitial
pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe
impairment of lung function, etc
\. Has received allogeneic cell / tissue / organ transplantation
\. According to the judgment of the researcher, there are other factors that
may cause the study to be forced to terminate halfway, For example, other
serious diseases (including mental diseases) need to be treated in
combination, with serious laboratory abnormalities, and Court or social
factors
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