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Lung CancerPhase 1NCT03628521

First-line Combination Treatment Based on Anlotinib

A Phase 1 study testing Anlotinib，Erlotinib，IBI308，Pemetrexed，gemcitabine，carboplatin in people with Lung Cancer and Advanced Stage, run by Shanghai Chest 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 The sponsor has not verified this record for over two years, so it may be out of date.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 aim of this study is to explore safety and therapeutic efficacy of anlotinib combined with erlotinib/chemotherapy/IBI308 as first-line treatment in advanced NSCLC patients. The primary endpoints of the study are safety and objective response rate (ORR);the secondary endpoints are disease control rate (DCR)… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lung Cancer, Advanced Stage
What is being tested?
Anlotinib，Erlotinib，IBI308，Pemetrexed，gemcitabine，carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
20 Jul 2018to 31 Dec 2020
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

  • Patients have voluntarily to join the study and give written informed consent for the study
  • Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC)
  • A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology)
  • Mutation status including EGFR, ALK ROS are explicit;
  • At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
  • Patients did not receive systemic anti-cancer therapy previously, including traditional Chinese medicine.
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  • Able to comply with study and follow-up procedures
  • Age ≥ 18 years and ≤ 75, ECOG PS: 0~1, estimated survival duration more than 3 months;enough organ function;
  • 8)Major organ function
  • For regular test results（no blood transfusion within 14 days）：
  • Hemoglobin（HB）≥90g/L；
  • Absolute neutrophils count（ANC）≥1.5×109/L；
  • Blood platelets（PLT）≥80×109/L
  • Biochemical tests results defined as follows：
  • Total bilirubin（TBIL）≤1.5 times the upper limit of normal (ULN) ；
  • Alanine aminotransferase（ALT）and aspartate aminotransgerase AST≤2.5ULN，liver metastases，if any，ALT和AST≤5ULN；
  • Creatinine（Cr）≤1.5ULN or Creatinine Clearance rate (CCr)≥60 ml/min；
  • Doppler ultrasound assessment：left ventricular ejection fraction (LVEF) ≥the lower limit of normal value(50%).

Who cannot join

  • Small cell lung cancer(including patients with mixed small cell lung cancer and non-small cell lung cancer) or central squamous cell carcinoma with cavity
  • Mutation status are unknown
  • Previously (within 5 years) or presently suffering from other malignancies,
  • Symptomatic or uncontrolled brain metastases
  • Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months or serious cardiac arrhythmia requiring medication
  • History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
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  • Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption
  • Pregnancy or lactation
  • Previously treated including treated with traditional Chinese medicine
  • Patients who are allergic to any of the agent or any ingredient -

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

    Baohui Han, MD，PhD, +8618930858216, 18930858216@163.com

    Recruiting

Other trials in China

About this study

Official title: Anlotinib-based Combination as First-line Treatment in Advanced Non-small Cell Lung Cancer: a Single Center, Three Arms and Exploratory Study

The aim of this study is to explore safety and therapeutic efficacy of anlotinib combined with erlotinib/chemotherapy/IBI308 as first-line treatment in advanced NSCLC patients. The primary endpoints of the study are safety and objective response rate (ORR);the secondary endpoints are disease control rate (DCR), progression-free survival (PFS) and overall survival (OS).

Being tested
Anlotinib，Erlotinib，IBI308，Pemetrexed，gemcitabine，carboplatin
Keywords
lung cancer, first-line, combination
Medical subject headings
Lung Neoplasms

What participants receive

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

  • Anlotinib，Erlotinib，IBI308，Pemetrexed，gemcitabine，carboplatinDrug

    Patient harboring EGFR mutation will be enrolled into arm A. Patients without sensitive EGFR mutation will be assigned to either arm B or arm C based on patients' or treating physicians'choice

Study groups in NCT03628521
Study groupRoleWhat they receive
arm AOtherAnlotinib combined with erlotinib. Anlotinib will be given at a dose of 10mg once daily on days 1-14 of a 21-day cycle. Erlotinib will be given at a dose of 150mg once daily.
Receives: Drug: Anlotinib，Erlotinib，IBI308，Pemetrexed，gemcitabine，carboplatin
arm BOtherAnlotinib combined with chemotherapy. Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle. Pemetrexed (just for adenocarcinoma) will be given intravenously at a dose of 500mg per square meter of body surface area every 3 weeks; gemcitabine (just for squamous carcinoma) will be given intravenously at a dose of 1000mg per square meter of body surface area every 3 weeks; carboplatin will be given intravenously with a target area under the curve of 5 mg per milliliter per minute every 3 weeks.
Receives: Drug: Anlotinib，Erlotinib，IBI308，Pemetrexed，gemcitabine，carboplatin
arm COtherAnlotinib combined with IBI308. Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle. IBI308 will be given intravenously at a dose of 200mg every 3 weeks.
Receives: Drug: Anlotinib，Erlotinib，IBI308，Pemetrexed，gemcitabine，carboplatin

What is being measured

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

  1. Safety will be assessed according to common terminology criteria for adverse events version 4.0 (CTC AE 4.0)

    Measured: from initiation of treatment to 90 days after the treatment finished

  2. ORR

    Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR)

    Measured: at the time of 8 weeks (2 cycles after treatment)

Secondary outcomes (3)

  1. DCR

    Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1) and the percentage of patients who achieved CR, PR and SD was defined as disease control rate (DCR).

    Measured: at the time of 8 weeks (2 cycles after treatment)

  2. PFS

    PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.

    Measured: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months

  3. OS

    OS is calculated from diagnosis to death or last follow-up time.

    Measured: From date of treatment until the date of death from any cause, assessed up to 50 months

Timeline

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

  1. First posted14 Aug 2018
  2. Study start20 Jul 2018
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 Dec 2020 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03628521
Sponsor's protocol ID
ACTION
Status last verified
Aug 2018
First submitted
7 Aug 2018
Last updated
14 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The data used or analyzed during the current study are available from the principle investigator on reasonable request after 6 months of the project is finished.

Publications

  • Chu T, Zhong R, Zhong H, Zhang B, Zhang W, Shi C, Qian J, Zhang Y, Chang Q, Zhang X, Dong Y, Teng J, Gao Z, Qiang H, Nie W, Zhao Y, Han Y, Chen Y, Han B. Phase 1b Study of Sintilimab Plus Anlotinib as First-line Therapy in Patients With Advanced NSCLC. J Thorac Oncol. 2021 Apr;16(4):643-652. doi: 10.1016/j.jtho.2020.11.026. Epub 2021 Jan 29.

    PubMed 33524601

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Anlotinib，Erlotinib，IBI308，Pemetrexed，gemcitabine，carboplatin in people with Lung Cancer and Advanced Stage, run by Shanghai Chest 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 18 inclusion and 10 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 14 Aug 2018. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety will be assessed according to common terminology criteria for adverse events version 4.0 (CTC AE 4.0) (time frame: from initiation of treatment to 90 days after the treatment finished). The study lists 2 primary outcomes in all. 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 NCT03628521, which also lists 1 linked publication.

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 14 Aug 2018.

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