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NSCLCPhase 2NCT04164745

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

A Phase 2 study testing Anlotinib, oral capsule and Pembrolizumab in people with NSCLC, run by Peking Union Medical College 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to assess the safety and efficacy of Anlotinib (AL3818) combined with pembrolizumab (MK-3475) in treatment-naïve 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)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC
What is being tested?
Anlotinib, oral capsule and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteChina
Study dates
16 Nov 2019to 16 Nov 2022
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

  • 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 (TPS≥1%) 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).
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  • Has a life expectancy of ≥3 months.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Has adequate organ function:
  • .HB≥90g/L;
  • ANC≥1.5×109/L；
  • PLT≥100×109/L；
  • WBC≥4.0×109/L and ≤15×109/L;
  • ALT and AST≤1.5×ULN(≤5×ULN in patients with liver metastases);
  • ALP≤2.5×ULN;
  • TBiL≤1.5×ULN;
  • ALB≥30g/L;
  • TSH≤ULN(If abnormal, T3 and T4 levels should be examined; If T3 and T4 levels are normal, they can be enrolled);
  • Cr≤1.5×ULN，and CrCL≥60mL/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.

Who cannot join

  • 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.
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  • 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 pressure≥140 mm Hg or diastolic pressure≥90 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.

Trial locations and contacts

1 site in 1 country.

xiaoxia cui, master contact

13126708633

cuixiaoxia8462@163.com

China1 site, 1 recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    xiaoxia cui, master, 13126708633, cuixiaoxia8462@163.com

    Recruiting

Other trials in China

About this study

The purpose of this study is to assess the safety and efficacy of Anlotinib (AL3818) combined with pembrolizumab (MK-3475) in treatment-naïve 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).

Conditions
NSCLC
Being tested
Anlotinib, oral capsule, Pembrolizumab

What participants receive

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

  • Anlotinib, oral capsuleDrug

    Participants receive Anlotinib 12 mg p.o, qd on Days 1-14 of each 3-week cycle until progressive disease or unacceptable toxicity plus pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).

  • PembrolizumabBiological

    Participants receive Anlotinib 12 mg p.o, qd on Days 1-14 of each 3-week cycle until progressive disease or unacceptable toxicity plus pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).

Study groups in NCT04164745
Study groupRoleWhat they receive
Experimental: Anlotinib plus PembrolizumabExperimentalNot described
Receives: Drug: Anlotinib, oral capsule; Biological: Pembrolizumab

What is being measured

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

  1. Progression-free Survival (PFS) as assessed by RECIST 1.1

    PFS is defined as the time from date of enrollment to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first per RECIST 1.1.

    Measured: Up to approximately 24 months

Secondary outcomes (5)

  1. Objective Response Rate (ORR) as assessed by RECIST 1.1

    ORR is defined as the percentage of participants in the analysis population who have a Complete Response(CR) or a Partial Response(PR) per RECIST 1.1.

    Measured: Up to approximately 24 months

  2. Disease Control Rate (DCR) as assessed by RECIST 1.1

    DCR is defined as the percentage of participants in the analysis population who have a CR, PR or stable disease per RECIST 1.1.

    Measured: Up to approximately 24 months

  3. Overall Survival (OS)

    OS is defined as the time from date of enrollment to date of death from any cause.

    Measured: Up to 12 months after last patient last visit

  4. Progression Free Survival 2 (PFS2)

    PFS2 will be defined as beginning with enrollment and ending with the first of the following events: a) death; b) disease progression on any treatment given after 1st progression. The determination of disease progression will be based on RECIST 1.1 criteria.

    Measured: Up to 12 months after last patient last visit

  5. Toxicity Rate

    Toxicity Rate is defined as the percentage of patients, relative to the total of enrolled subjects, experiencing adverse event (AE) including AE of all level, AE of grade 3/4, irAE

    Measured: Up to 12 months after last patient last visit

Timeline

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

  1. First posted15 Nov 2019
  2. Study start16 Nov 2019 (estimated)
  3. Primary completion16 Nov 2021 (estimated)
  4. Study completion16 Nov 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04164745
Sponsor's protocol ID
ALTER-L037
Status last verified
Nov 2019
First submitted
13 Nov 2019
Last updated
15 Nov 2019
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 Anlotinib, oral capsule and Pembrolizumab in people with NSCLC, run by Peking Union Medical College 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 20 inclusion and 21 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 15 Nov 2019. 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 xiaoxia cui, master (13126708633, cuixiaoxia8462@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) as assessed by RECIST 1.1 (time frame: Up to approximately 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 NCT04164745.

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 15 Nov 2019.

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