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Non-squamous Cell Non-Small Cell Lung CancerPhase 1NCT03790228

Anlotinib Combined With Pemetrexed And Carboplatin as First-line Treatment in Advanced Nonsquamous NSCLC

A Phase 1 study testing Anlotinib Combined With Pemetrexed And Carboplatin in people with Non-squamous Cell Non-Small Cell Lung Cancer, run by Henan Cancer 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 The sponsor has not verified this record for over two years, so it may be out of date.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

In recent years, with the progress in the treatment field, Non-Small Cell Lung Cancer(NSCLC) has become the most successful cancer species in precision medicine. Patients with positive driving genes such as EGFR, ALK, ROS1, BRAF and so on have clearly targeted drugs, which bring survival benefits to patients.However… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Anlotinib Combined With Pemetrexed And Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteChina
Study dates
22 Mar 2019to 31 Aug 2021
Phase
Phase 1
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

  • Signed the informed consent form prior to patient entry;
  • Male or female patients aged 18-75 years old;
  • Diagnosed with advanced NSCLC (phase IIIB/IV) through pathology, Neoadjuvant chemotherapy, or postoperative adjuvant chemotherapy or neoadjuvant chemotherapy combined with postoperative adjuvant chemotherapy or targeted chemoradiotherapy for local advanced disease recurrence within 6 months after completion;
  • In the past 3 months at least one target lesion that had not previously been irradiated,and at least one direction with the longest diameter at baseline greater than 10 mm (shorter diameter required not less than 15 mm if lymph nodes are involved)could be imaged by CT scan or MRI;
  • Expected Survival Time: Over 6 months;
  • Had an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1 (on a 5-point scale, with higher scores indicating increasing disability);
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  • The main organs function are normally, the following criteria are met:(1)Blood routine examination criteria should be met (no blood transfusion and blood products within 14 days, no correction by G-CSF and other hematopoietic stimuli): HB≥90 g/L; ANC ≥ 1.5×10^9/L; PLT ≥80×10^9/L;(2)Biochemical examinations must meet the following criteria: TBIL<1.5×ULN; ALT and AST < 2.5×ULN, and for patients with liver metastases < 5×ULN; Serum Cr ≤ 1.25×ULN or endogenous creatinine clearance > 60 ml/min (Cockcroft-Gault formula);
  • Women of child-bearing age should take appropriate contraceptive measures and should not breastfeed from screening to 3 months after stopping the study and treatment.Before starting administration, the pregnancy test was negative, or one of the following criteria was met to prove that there was no risk of pregnancy:
  • Postmenopause is defined as amenorrhea at least 12 months after age 50 and cessation of all exogenous hormone replacement therapy;
  • Postmenopausal women under the age of 50 May also be considered postmenopausal if their amenorrhea is 12 months or more after the cessation of all exogenous hormone therapy and their luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the reference value range of laboratory postmenopausal;
  • Has undergone irreversible sterilization surgery, including hysterectomy, bilateral ovectomy or bilateral salpingectomy, except for bilateral tubal ligation.
  • For men, consent is required to use appropriate methods of contraception or to be surgically sterilized during the trial and 8 weeks after the last administration of the trial drug.

Who cannot join

  • Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer),Lung sarcomatoid carcinoma;
  • Had histologically confirmed lung squamous cell carcinoma, or adenosquamous carcinoma;
  • Patients with pathological fracture in bone metastasis of non-small-cell lung cancer;
  • Tumor histology or cytology confirmed EGFR mutagenesis [EGFR sensitive mutations include 18 exon point mutations (G719X), 19 exon deletions, 20 exon S768I mutations and 21 exon point mutations (L858R and L861Q)] and ALK gene rearrangement positivity, include EGFR/ALK status cannot be determined for various reasons;
  • Imaging (CT or MRI) shows that the distance between tumor lesion and the large blood vessel is ≤ 5 mm, or there is a central tumor that invades the local large blood vessel; or there is a significant pulmonary cavity or necrotizing tumor;
  • Medical history and combined history：
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  • Active brain metastases, cancerous meningitis, spinal cord compression, or imaging CT or MRI screening for brain or pia mater disease (a patient with brain metastases who have completed treatment and stable symptoms in 28 days before enrollment may be enrolled, but should be confirmed by brain MRI, CT or venography evaluation as no cerebral hemorrhage symptoms and metastases in midbrain, pons, cerebellum, medulla oblongata, or spinal cord, brain metastases and local radiotherapy after two weeks to allow group);
  • The patient is participating in other clinical studies or completing the previous clinical study in less than 4 weeks;
  • Had malignant tumors except NSCLC within 5 years before enrollment(except for patients with cervical carcinoma in situ , basal cell or squamous cell skin cancer who have undergone a curative treatment, local prostate cancer after radical resection, ductal carcinoma in situ or papillary thyroid cancer after radical resection);
  • Abnormal blood coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;Note: Under the premise of prothrombin time international normalized ratio (INR) ≤ 1.5, low-dose heparin (adult daily dose of 0.6 million to 12,000 U) or low-dose aspirin (daily dosage ≤ 100 mg) is allowed for preventive purposes;
  • Renal insufficiency: urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0g;
  • The effects of surgery or trauma have been eliminated for less than 14 days before enrollment in subjects who have undergone major surgery or have severe trauma;
  • Severe acute or chronic infections requiring systemic treatment;
  • Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms); according to NYHA criteria, grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) <50%;
  • There is currently a peripheral neuropathy of ≥CTCAE 2 degrees, except for trauma;
  • Respiratory syndrome (≥CTC AE grade 2 dyspnea), serous effusion (including pleural effusion, ascites, pericardial effusion) requiring surgical treatment;
  • Long-term unhealed wounds or fractures;
  • Decompensated diabetes or other ailments treated with high doses of glucocorticoids;
  • Factors that have a significant impact on oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
  • Clinically significant hemoptysis (daily hemoptysis greater than 50ml) within 3 months prior to enrollment; or significant clinically significant bleeding symptoms or defined bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ and above, or suffering from vasculitis;
  • Events of venous/venous thrombosis occurring within the first 12 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
  • Physical examination and laboratory findings:
  • A known history of HIV testing positive or acquired immunodeficiency syndrome (AIDS);
  • Untreated active hepatitis (hepatitis b: HBsAg positive and HBV DNA more than 1 x 103 copy /ml; Hepatitis c: HCV RNA is positive and liver function is abnormal); Combined with hepatitis b and hepatitis c infection;
  • Serious diseases that endanger patients' safety or affect patients' completion of research,according to the researchers' judgment.

Trial locations and contacts

1 site in 1 country.

Qiming Wang, Doctor contact

0086-13783590691

mysubmission@126.com

China1 site, 1 recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Qiming Wang, doctor

    Recruiting

Other trials in China

About this study

Official title: Anlotinib Combined With Pemetrexed And Carboplatin Followed by Maintenance Therapy With Anlotinib Plus Pemetrexed as the First-line Treatment in Patients With Advanced Nonsquamous NSCLC

In recent years, with the progress in the treatment field, Non-Small Cell Lung Cancer(NSCLC) has become the most successful cancer species in precision medicine. Patients with positive driving genes such as EGFR, ALK, ROS1, BRAF and so on have clearly targeted drugs, which bring survival benefits to patients.However, about 50% of patients still lack a clear driving gene target, which has become the focus of current research.In the field of wild-type NSCLC with negative driver genes, the classic first-line treatment regimen is the two-drug regimen containing platinum.The study by Kimura T in the first-line treatment of 54 wild-type advanced NSCLC patients with carboplatin and pemetrexed showed that the ORR, mPFS and mOS of patients with wild-type non-squamous NSCLC treated with carboplatin permetrexine were 35.8%, 5.4 months and 12.7 months respectively.

Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development.In the phase Ⅲ study, patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib or placebo, the anlotinib group PFS and OS were 5.37 months and 9.46 months, the placebo group PFS and OS were 1.4 months and 6.37 months.

The efficacy and safety of Anlotinib combined with Pemetrexed and Carboplatin followed by maintenance therapy with Anlotinib plus Pemetrexed as the first-line treatment in patients with advanced nonsquamous NSCLC deserve further exploration.

Read the detailed description

This is a multicentre single arm clinical trial conducted in China.The purpose of this study is to evaluate and observe Anlotinib (12mg,QD, PO d1-14, 21 days per cycle) combined with Pemetrexed(500mg/m2,IV,d15-21,21 days per cycle)and Carboplatin(AUC5,IV,d15-21,21 days per cycle,4 cycles) as the first-line treatment in patients with advanced nonsquamous NSCLC .After four cycles of induction,patients continued to receive Anlotinib and Pemetrexed.As the report,The median PFS of advanced NSCLC treated by Pemetrexed and Carboplatin was 6 months.We expect the median PFS of Anlotinib combined with Pemetrexed and Carboplatin as the first-line treatment in patients with advanced nonsquamous NSCLC was 10 months.Using PASS15, we calculated the sample size of this study was 34(α=0.05、β=0.2), according to 20% censoring,the expected sample size is 43.

Being tested
Anlotinib Combined With Pemetrexed And Carboplatin
Keywords
nonsquamous NSCLC, Anlotinib, Pemetrexed, Carboplatin, First-line

What participants receive

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

  • Anlotinib Combined With Pemetrexed And CarboplatinDrug

    Anlotinib(12mg, QD, PO, d1-14, 21 days per cycle) plus Pemetrexed (500mg/m2, IV, d15-21,21 days per cycle) and Carboplatin(AUC5,IV, d15-21,21 days per cycle,using 4 cycles)

Study groups in NCT03790228
Study groupRoleWhat they receive
Anlotinib Combined With Pemetrexed And CarboplatinExperimentalAnlotinib(12mg, QD, PO, d1-14, 21 days per cycle) plus Pemetrexed (500mg/m2, IV, d15-21,21 days per cycle) and Carboplatin(AUC5,IV, d15-21,21 days per cycle,using 4 cycles)
Receives: Drug: Anlotinib Combined With Pemetrexed And Carboplatin

What is being measured

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

  1. Progression free survival，PFS

    PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.

    Measured: each 42 days up to PD or death(up to 24 months)

Secondary outcomes (4)

  1. Objective Response Rate,ORR

    ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.

    Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)

  2. Disease Control Rate,DCR

    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

    Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months).

  3. Overall Survival,OS

    Defined as the time until death due to any cause.

    Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months) .

  4. Safety(Number of Participants with Adverse Events )

    Number of Participants with Adverse Events.

    Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months).

Timeline

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

  1. First posted31 Dec 2018
  2. Study start22 Mar 2019
  3. Primary completion1 Oct 2020 (estimated)
  4. Study completion31 Aug 2021 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Anlotinib combined with Pemetrexed and Carboplatin
Masking
None (open label)
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03790228
Sponsor's protocol ID
ALTER L012
Status last verified
Dec 2019
First submitted
27 Dec 2018
Last updated
15 Apr 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Anlotinib Combined With Pemetrexed And Carboplatin in people with Non-squamous Cell Non-Small Cell Lung Cancer, run by Henan Cancer 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 12 inclusion and 25 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 Apr 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 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.

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 Qiming Wang, Doctor (0086-13783590691, mysubmission@126.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 (time frame: each 42 days up to PD or death(up to 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 NCT03790228.

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 Apr 2020.

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