NSCLCPhase 1/2NCT04670107
The Combination of Anlotinib and Immune Checkpoint Inhibitors for Advanced NSCLC Patients With Muti-line Therapy
A Phase 1/2 study testing Anlotinib in combination with Immune checkpoint inhibitors in people with NSCLC and Angiogenesis, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
Immunotherapy has made a major progress in Lung cancer.However, challenges such as primary and acquired resistance, small fraction of benefit population and lack of predictive and prognostic biomarkers even exist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Angiogenesis, Immunotherapy
- What is being tested?
- Anlotinib in combination with Immune checkpoint inhibitors
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 1 Nov 2020
- Phase
- Phase 1/2
- 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
- Signed Informed Consent Form
- Ability to comply with protocol
- Aged ≥ 18 years Histologically documented NSCLC that is currently locally advanced or metastatic NSCLC Disease progression during or following at least one line treatment. Measurable disease, as defined by RECIST v1.1
- ECOG performance status of 0 or 1
- Life expectancy ≥ 12 weeks
- Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment: ANC ≥ 1.5 × 109/L (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility) WBC counts > 2.5 × 109/L and < 15 × 109/L Lymphocyte count ≥ 0.5 × 109/L Serum albumin ≥ 2.5 g/dL Platelet count ≥ 100 × 109/L (without transfusion within 2 weeks of laboratory test used to determine eligibility) Hemoglobin ≥ 9.0 g/dL Patients may be transfused or receive erythropoietic treatment to meet this criterion.
- Liver function tests meeting one of the following criteria:
- AST or ALT ≤ 2.5 × upper limit of normal (ULN), with alkaline phosphatase ≤ 2.5 × ULN or AST and ALT ≤ 1.5 × ULN in conjunction with alkaline phosphatase > 2.5 × ULN Serum bilirubin ≤ 1.5 × ULN Patients with known Gilbert's disease who have serum bilirubin level ≤ 3 × ULN may be enrolled. INR and aPTT ≤ 1.5 × ULN This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose for at least 1 week prior to randomization. Creatinine clearance ≥ 30 mL/min Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration, or Modification of Diet in Renal Disease formulas may be used for creatinine clearance calculation. Note that 24-hour urine collection is not required but is allowed.
Who cannot join
- Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments Leptomeningeal disease • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures Uncontrolled hypertension Perior used anti-angiogenic agents or immune checkpoint inhibitors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Combination of Anlotinib and Immune Checkpoint Inhibitors for Progressed NSCLC Patients With Muti-line Therapy : a PhaseⅠB Clinical Study
Immunotherapy has made a major progress in Lung cancer.However, challenges such as primary and acquired resistance, small fraction of benefit population and lack of predictive and prognostic biomarkers even exist. The overall objective response rate is lower than 20% in second line-treatment and the progression-free survival (PFS) is also similar to or poorer than that of conventional second-line chemotherapy. Anlotinib is a novel, orally administered, multitarget receptor tyrosine kinase inhibitor that inhibits VEGFR, PDGFR, FGFR, c-Kit, and other kinases. It functions by inhibiting tumor angiogenesis and proliferative signaling pathways. We would observe and analyze the effectiveness and safety of anlotinib combined with Immune checkpoint inhibitors for advanced NSCLC after muti-line therapy to explore the synergistic effect of anti-angiogenic agents and immunotherapy.
- Conditions
- NSCLC, Angiogenesis, Immunotherapy
- Being tested
- Anlotinib in combination with Immune checkpoint inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib in combination with Immune checkpoint inhibitorsDrug
Enrolled patients received anlotinib plus Pembrolizumab treatment (anlotinib, 8-12mg, qd, 2 weeks in a row and 1 week off; anti-PD1 injection or anti-PDL1 injection, Following instructions, iv.)
| Study group | Role | What they receive |
|---|---|---|
| combination group | Experimental | Not described Receives: Drug: Anlotinib in combination with Immune checkpoint inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
the progression-free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
OS
the over survival
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
AE
adverse event caused by the combination
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jun 2018
- Primary completion1 Oct 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhangxiaochun, The Affiliated Hospital of Qingdao University
- Investigators
- Zhang, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670107
- Sponsor's protocol ID
- ANLOIM
- Status last verified
- Dec 2020
- First submitted
- 27 Nov 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of Anlotinib and Immune Checkpoint Inhibitors for Progressed NSCLC Patients With Muti-line Therapy : a PhaseⅠB Clinical Study
- ClinicalTrials.gov ID
- NCT04670107
- Acronym / sponsor ID
- ANLOIM
- Conditions
- NSCLC, Angiogenesis, Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Immunotherapy has made a major progress in Lung cancer.However, challenges such as primary and acquired resistance, small fraction of benefit population and lack of predictive and prognostic biomarkers even exist. The overall objective response rate is lower than 20% in second line-treatment and the progression-free survival (PFS) is also similar to or poorer than that of conventional second-line chemotherapy. Anlotinib is a novel, orally administered, multitarget receptor tyrosine kinase inhibitor that inhibits VEGFR, PDGFR, FGFR, c-Kit, and other kinases. It functions by inhibiting tumor angiogenesis and proliferative signaling pathways. We would observe and analyze the effectiveness and safety of anlotinib combined with Immune checkpoint inhibitors for advanced NSCLC after muti-line therapy to explore the synergistic effect of anti-angiogenic agents and immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| combination group | Experimental | Drug: Anlotinib in combination with Immune checkpoint inhibitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed Informed Consent Form
- AST or ALT ≤ 2.5 × upper limit of normal (ULN), with alkaline phosphatase ≤ 2.5 × ULN or AST and ALT ≤ 1.5 × ULN in conjunction with alkaline phosphatase > 2.5 × ULN Serum bilirubin ≤ 1.5 × ULN Patients with known Gilbert's disease who have serum bilirubin level ≤ 3 × ULN may be enrolled. INR and aPTT ≤ 1.5 × ULN This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose for at least 1 week prior to randomization. Creatinine clearance ≥ 30 mL/min Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration, or Modification of Diet in Renal Disease formulas may be used for creatinine clearance calculation. Note that 24-hour urine collection is not required but is allowed.
Key exclusion criteria (1 listed)
- Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments Leptomeningeal disease • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures Uncontrolled hypertension Perior used anti-angiogenic agents or immune checkpoint inhibitors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anlotinib in combination with Immune checkpoint inhibitorsEnrolled patients received anlotinib plus Pembrolizumab treatment (anlotinib, 8-12mg, qd, 2 weeks in a row and 1 week off; anti-PD1 injection or anti-PDL1 injection, Following instructions, iv.) | Drug | combination group |
Primary outcome
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
the progression-free survival
OS
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
the over survival
AE
Time frame: through study completion, an average of 1 year
adverse event caused by the combination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang principal investigator
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Anlotinib in combination with Immune checkpoint inhibitors in people with NSCLC and Angiogenesis, run by The Affiliated Hospital of Qingdao University 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 8 inclusion and 1 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: finished, as of the sponsor's last update on 17 Dec 2020. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2020.