Non-squamous Non-small Cell Lung CancerNCT03671538
Non Squamous NSCLC Patients With Anlotinib Combined With Pemetrexed and Cisplatin
A study testing Anlotinib, pemetrexed and Cisplatin in people with Non-squamous Non-small Cell Lung Cancer, run by Lingyu Luo.
Trial summary
Chemotherapy is still the standard first-line treatment option for EGFR unmutated patients. After a randomized phase Ⅲ trial, BEYOND was presented the synergistic effect of progression-free survival(PFS) could be expected when chemotherapy is combined with Antiangiogenesis agent bevacizumab in China;Therefore,in this… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-squamous Non-small Cell Lung Cancer
- What is being tested?
- Anlotinib, pemetrexed and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 31 Aug 2020
- Phase
- Interventional
- 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
- Be≥18 years of age on the day of signing informed consent and With good compliance and agree to accept follow-up of disease progression and adverse events.
- Patients with histologic or cytologic confirmation of advanced or metastatic Non squamous NSCLC with stage IIIB or IV disease.（For recurrent patients, adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant were assessed for eligibility, and the last treatment time must be more than 6 months before enrollment）
- Patients have not been received systematic treatment，including chemotherapy and EGFR-TKIs
- EGFR mutations confirmed by molecular detection (including, but not limited to, T790M, 19 exon deletion and L858R) external pathological examination was accepted (including pathological or blood test results)
- There were at least one target lesions in the past three months has not yet accepted radiotherapy, and could be recorded by magnetic resonance imaging (MRI) or computer tomography (CT) measuring accurately at least in one direction(The maximum diameter needs to be recorded), including conventional CT ≥20 mm or spiral CT ≥10 mm.
- Life expectancy ≥3 months.
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- Have a performance status of 0 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- With normal marrow, liver ,renal and coagulation function:
- The blood routine examination need to be standard (no blood transfusion and blood products within 14 days, no g-csf and other hematopoietic stimulating factor correction)
- Hemoglobin（HB）≥90 g/L
- A Neutrophil count of （ANC）≥1.5×109/L
- A Platelet count of （PLT）≥80×109/L
- A total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL)
- A alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL, in case of liver metastasis ALAT and ASAT≤5 UNL
- A creatinine (Cr) of ≤1.5 UNL; a creatinine clearance rate ≥ 60ml/min (Cockcroft-Gault)
- Doppler echocardiography: left ventricular ejection fraction (LVEF) is lower than normal (50%)
- Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug.
Who cannot join
- Small cell lung cancer (include Small cell lung cancer mixture of NSCLC)
- Iconography (CT or MRI) shows that the tumor vessels have 5 mm or less, or Cardiovascular involvement by Central tumor ; Or obvious lung empty or necrotic tumor
- Patients with Other active malignant tumors requiring concurrent treatment;
- Patients has a history of malignant tumors. Patients with basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, or cervical cancer in situ who have undergone possible curative treatment and have not suffered any recurrence of the disease within 5 years from the start of treatment
- Patients with brain or central nervous system metastases, including leptomeningeal disease, or CT/MRI examination revealed brain or leptomeningeal disease） (14 days before the random treatment has been completed and the symptoms of patients with brain metastases from stable can into the group, but need to the cerebral MRI, CT or vein angiography confirmed as without symptoms of cerebral hemorrhage).
- Patients who have not recovered to grade 1 or below according to NCI-CTCAE4.0 after previous systemic antitumor therapy (except alopecia)
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- Uncontrollable hypertensive (systolic blood pressure or greater 140 mmHg or diastolic blood pressure or greater 90 mmHg, despite the best drug treatment)
- Patients with NCI-CTCAE grade II or greater peripheral neuropathy, except due to trauma
- Significant cardiac disease as defined as: grade II or greater myocardial infarction, unstable arrhythmia(Including corrected QT interval (QTc )period between male or greater 450 ms, female or greater 470 ms); New York Heart Association (NYHA) grade II or greater heart dysfunction , or Echocardiography reveal left ventricular ejection fraction （LVEF）Less than 50%
- Abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT ULN > 1.5), with bleeding tendency or be treated with thrombolysis and anticoagulation. Note: under the premise of International Normalized ratio (INR) of prothrombin time (PT) Less than or equal to 1.5, allow to administrate low-dose heparin (adult daily dose is 06000 ~ 12000 U) or low-dose aspirin (100 mg daily dosage or less) , for prophylactic purposes.
- Urine routines show urine protein≥ ++, or urine protein quantity≥ 1.0 g during 24 hours
- Patients with severe infections , and need to receive systemic antibiotic treatment.（according to the CTC AE4.0, the infection with grade 2 or above and requiring intravenous antibacterial therapy ）;Decompensated diabetes or other contraindication with high dose glucocorticoid therapy）
- Patients with respiratory syndrome (difficulty breathing of level 2 or higher according to the CTC AE), serous cavity effusion need to surgical treatment (according to the CTC AE4.0, including pleural of level 2 or higher with respiratory distress and anoxia, need for intubation or pleurodesis treatment, severe ascites of level 2 need to surgery invasive treatment, pericardial of level 2 and affect physiological function)
- Serious, non-healing wound, ulcer, or bone fracture
- Active or chronic hepatitis c and/or Hepatitis B virus (HBV) infection
- Has an obvious factor influencing oral drug absorption, such as unable to swallow, chronic diarrhea and intestinal obstruction, etc
- Has received major surgery or severe traumatic injury, fractures or ulcer Within 4weeks before Random
- Patients have participated in other antitumor drug clinical trials Within 4 weeks before enrollment or prepare to receive systemic anti-tumor treatment during the study or Within 4 weeks before randomization, including cytotoxic therapy cellular, Signal transduction inhibitors, immune therapy (or receiving mitomycin C Within six weeks before taking experimental drug therapy).Field overspread radiotherapy (ef-rt) was carried out within 4 weeks before the grouping or limited field radiotherapy was carried out within 2 weeks before the grouping to evaluate tumor lesions
- Severe weight loss (> 10%) Within 6 weeks before Random
- Has Clinically significant hemoptysis Within 3 months before Random (daily hemoptysis than 50 ml;Or significant clinical significance of bleeding symptoms or have definite bleeding tendency, such as gastrointestinal bleeding, bleeding ulcers, baseline period + + and above of fecal occult blood, or vasculitis, etc
- Has venous thromboembolism events Within 12 months before Random, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.
- Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Phase II Study of Anlotinib Combined With Pemetrexed and Cisplatin in First Treatment for Advanced Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Negative Mutations
Chemotherapy is still the standard first-line treatment option for EGFR unmutated patients. After a randomized phase Ⅲ trial, BEYOND was presented the synergistic effect of progression-free survival(PFS) could be expected when chemotherapy is combined with Antiangiogenesis agent bevacizumab in China;Therefore,in this study, The investigators will investigate the efficacy and safety of Anlotinb combined With Pemetrexed and Cisplatin as first-line therapy in patients with chemotherapy-naive, stage IIIB or IV, non-squamous NSCLC without targetable EGFR or ALK genetic aberrations.
Read the detailed description
This is a randomized, single -center study conducted in China to compare the efficacy and safety of Anlotinb combined With Pemetrexed and Cisplatin as first-line therapy in patients of Advanced Gene Negative Non-squamous Non-small Cell Lung Cancer.
Eligible patients will be randomized to arm A:
Patients were instructed to take 500mg/m2 pemetrexed as a 10-minute intravenous infusion and Cisplatin 75mg/m2 on day 1 of a 21-day cycle and12mg Anlotinib orally daily on day 1 to 14 of a 21-day cycle.If there was no evidence of disease progression following a maximum of 4-6 cycles of anlotinib plus chemotherapy, patients continued to receive single-agent anlotinib until disease progression or unacceptable toxicity. Approximately 62 patients will be enrolled to ensure complete treatments for primary endpoint analysis.
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Being tested
- Anlotinib, pemetrexed, Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
Anlotinib 12mg qd on day 1 to 14 of a 21-day cycle
pemetrexedDrug
pemetrexed 500mg/m2 on day 1 of a 21-day cycle ;
CisplatinDrug
Cisplatin 75mg/m2 on day 1 of a 21-day cycle ;
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib Plus Pemetrexed and Cisplatin | Experimental | pemetrexed 500mg/m2 and Cisplatin 75mg/m2 on day 1 of a 21-day cycle ;Anlotinib 12mg qd on day 1 to 14 of a 21-day cycle Receives: Drug: Anlotinib; Drug: pemetrexed; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
Measured: From enrollment to completion of study. Estimated about 24 months.
Secondary outcomes (5)
Overall Response Rate
Clinical response of treatment according to RESIST v1.1 criteria (ORR, Overall Response Rate)
Measured: From enrollment to progression of disease. Estimated about 24 months
disease control rate
Clinical response of treatment according to RESIST v1.1 criteria (DCR, disease control rate)
Measured: From enrollment to progression of disease. Estimated about 24 months
Overall Survival
From date of randomization until the date of death or date of last visit/contact, whichever came first
Measured: From enrollment to completion of study. Estimated about 24 months.
6-month PFS rate
Proportion of people who first documented disease progression or death from any cause, whichever came first ,during 6 months
Measured: From enrollment to analysis, Estimated about 6 months
12-month PFS rate
Proportion of people who first documented disease progression or death from any cause, whichever came first ,during 12 months
Measured: From enrollment to analysis. Estimated about 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Oct 2018 (estimated)
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-squamous Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lingyu Luo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lingyu Luo, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671538
- Sponsor's protocol ID
- ALTER-L008
- Status last verified
- Sep 2018
- First submitted
- 13 Sep 2018
- Last updated
- 17 Sep 2018
- 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 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Anlotinib Combined With Pemetrexed and Cisplatin in First Treatment for Advanced Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Negative Mutations
- ClinicalTrials.gov ID
- NCT03671538
- Acronym / sponsor ID
- ALTER-L008
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Lingyu LuoUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 14 Sep 2018 (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.
Chemotherapy is still the standard first-line treatment option for EGFR unmutated patients. After a randomized phase Ⅲ trial, BEYOND was presented the synergistic effect of progression-free survival(PFS) could be expected when chemotherapy is combined with Antiangiogenesis agent bevacizumab in China;Therefore,in this study, The investigators will investigate the efficacy and safety of Anlotinb combined With Pemetrexed and Cisplatin as first-line therapy in patients with chemotherapy-naive, stage IIIB or IV, non-squamous NSCLC without targetable EGFR or ALK genetic aberrations.
Detailed description
This is a randomized, single -center study conducted in China to compare the efficacy and safety of Anlotinb combined With Pemetrexed and Cisplatin as first-line therapy in patients of Advanced Gene Negative Non-squamous Non-small Cell Lung Cancer.
Eligible patients will be randomized to arm A:
Patients were instructed to take 500mg/m2 pemetrexed as a 10-minute intravenous infusion and Cisplatin 75mg/m2 on day 1 of a 21-day cycle and12mg Anlotinib orally daily on day 1 to 14 of a 21-day cycle.If there was no evidence of disease progression following a maximum of 4-6 cycles of anlotinib plus chemotherapy, patients continued to receive single-agent anlotinib until disease progression or unacceptable toxicity. Approximately 62 patients will be enrolled to ensure complete treatments for primary endpoint analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib Plus Pemetrexed and Cisplatin | Experimental | Drug: Anlotinib, Drug: pemetrexed, Drug: Cisplatinpemetrexed 500mg/m2 and Cisplatin 75mg/m2 on day 1 of a 21-day cycle ;Anlotinib 12mg qd on day 1 to 14 of a 21-day cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Be≥18 years of age on the day of signing informed consent and With good compliance and agree to accept follow-up of disease progression and adverse events.
- Patients with histologic or cytologic confirmation of advanced or metastatic Non squamous NSCLC with stage IIIB or IV disease.（For recurrent patients, adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant were assessed for eligibility, and the last treatment time must be more than 6 months before enrollment）
- Patients have not been received systematic treatment，including chemotherapy and EGFR-TKIs
- EGFR mutations confirmed by molecular detection (including, but not limited to, T790M, 19 exon deletion and L858R) external pathological examination was accepted (including pathological or blood test results)
- There were at least one target lesions in the past three months has not yet accepted radiotherapy, and could be recorded by magnetic resonance imaging (MRI) or computer tomography (CT) measuring accurately at least in one direction(The maximum diameter needs to be recorded), including conventional CT ≥20 mm or spiral CT ≥10 mm.
Key exclusion criteria (22 listed)
- Small cell lung cancer (include Small cell lung cancer mixture of NSCLC)
- Iconography (CT or MRI) shows that the tumor vessels have 5 mm or less, or Cardiovascular involvement by Central tumor ; Or obvious lung empty or necrotic tumor
- Patients with Other active malignant tumors requiring concurrent treatment;
- Patients has a history of malignant tumors. Patients with basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, or cervical cancer in situ who have undergone possible curative treatment and have not suffered any recurrence of the disease within 5 years from the start of treatment
- Patients with brain or central nervous system metastases, including leptomeningeal disease, or CT/MRI examination revealed brain or leptomeningeal disease） (14 days before the random treatment has been completed and the symptoms of patients with brain metastases from stable can into the group, but need to the cerebral MRI, CT or vein angiography confirmed as without symptoms of cerebral hemorrhage).
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 |
|---|---|---|
| AnlotinibAnlotinib 12mg qd on day 1 to 14 of a 21-day cycle | Drug | Anlotinib Plus Pemetrexed and Cisplatin |
| pemetrexedpemetrexed 500mg/m2 on day 1 of a 21-day cycle ; | Drug | Anlotinib Plus Pemetrexed and Cisplatin |
| CisplatinCisplatin 75mg/m2 on day 1 of a 21-day cycle ; | Drug | Anlotinib Plus Pemetrexed and Cisplatin |
Primary outcome
progression-free survival
Time frame: From enrollment to completion of study. Estimated about 24 months.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
5 secondary outcomes
Overall Response Rate
Time frame: From enrollment to progression of disease. Estimated about 24 months
disease control rate
Time frame: From enrollment to progression of disease. Estimated about 24 months
Overall Survival
Time frame: From enrollment to completion of study. Estimated about 24 months.
6-month PFS rate
Time frame: From enrollment to analysis, Estimated about 6 months
12-month PFS rate
Time frame: From enrollment to analysis. Estimated about 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Anlotinib, pemetrexed and Cisplatin in people with Non-squamous Non-small Cell Lung Cancer, run by Lingyu Luo.
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 17 inclusion and 22 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 17 Sep 2018. 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.
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 Xiong Jian ping, MD (13879109229, 13879109229@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 (time frame: From enrollment to completion of study. Estimated about 24 months.). 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 Sep 2018.