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Small Cell Lung CancerPhase 2NCT03059797

Study of Anlotinib in Patients With Small Cell Lung Cancer (ALTER1202)

A Phase 2 study testing Anlotinib in people with Small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To compare the effects and safety of Anlotinib with placebo in patients with small cell lung cancer(SCLC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Anlotinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
12 sitesChina
Study dates
27 Mar 2017to 6 May 2019
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological documentation of small cell lung cancer
  • Advanced small cell lung cancer who had at least two chemotherapy regimens,at least one measurable lesion (by RECIST1.1)
  • 18-75 years,ECOG PS:0-2,Life expectancy of more than 3 months
  • Main organs function is normal
  • Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
  • Patients should participate in the study voluntarily and sign informed consent

Who cannot join

  • Patients who have been used anlotinib
  • Patients who have been used targeted drugs(such as sunitinib,bevacizumab,endostar),Immune targeted drugs
  • 4 weeks or less from the last cytotoxic therapy, radiation therapy or surgery
  • Patients whose primary lesion with active bleeding within 4 months
  • Carcinomatous meningitis
  • Patients who known to the central nervous system
Show all 20Show fewer
  • Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
  • Patients with any severe and/or unable to control diseases，including：
  • Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
  • Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc≥450ms(male),QTc≥470ms（female）) and patients with Grade 1 or higher congestive heart failure (NYHA Classification);
  • Patients with active or unable to control serious infections;
  • Patients with cirrhosis, decompensated liver disease, or active hepatitis;
  • Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L)
  • Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed;
  • Patients with non-healing wounds or fractures
  • Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism
  • Patients with drug abuse history and unable to get rid of or Patients with mental disorders
  • Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage
  • History of immunodeficiency
  • Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • The 307th Hospital of Chinese People's Liberation Army

    Beijing, Beijing Municipality, 100071

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • Hunan Cancer Hospital

    Changsha, Hunan, 410006

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

  • Harbin medical university affiliated tumor hospital

    Harbin, Heilongjiang, 150081

  • Linyi Cancer Hospital

    Linyi, Shandong, 276000

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110042

  • Tianjin Medical University Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Small Cell Lung Cancer(ALTER1202)

To compare the effects and safety of Anlotinib with placebo in patients with small cell lung cancer(SCLC).

Being tested
Anlotinib, Placebo
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • AnlotinibDrug

    Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle

  • PlaceboDrug

    Placebo Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle

Study groups in NCT03059797
Study groupRoleWhat they receive
AnlotinibExperimentalAnlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle
Receives: Drug: Anlotinib
PlaceboPlacebo comparatorPlacebo Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle
Receives: Drug: Placebo

What is being measured

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

  1. Progress free survival (PFS)

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

Secondary outcomes (4)

  1. Overall Survival (OS)

    Measured: From randomization until death (up to 24 months)

  2. Objective Response Rate (ORR)

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

  3. Disease Control Rate (DCR)

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

  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Measured: Until 30 day safety follow-up visit (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 posted23 Feb 2017
  2. Study start27 Mar 2017
  3. Primary completion30 Jun 2018
  4. Study completion6 May 2019

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03059797
Sponsor's protocol ID
ALTN-12-II
Status last verified
May 2019
First submitted
16 Feb 2017
Last updated
16 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Gong J, Wan Q, Shang J, Qian X, Su D, Sun Z, Liu G. Cost-Effectiveness Analysis of Anlotinib as Third- or Further-Line Treatment for Relapsed Small Cell Lung Cancer (SCLC) in China. Adv Ther. 2021 Oct;38(10):5116-5126. doi: 10.1007/s12325-021-01889-2. Epub 2021 Aug 21.

    PubMed 34417989

  • Zhang C, Wang J, Wang X, Meng Z, Cheng Y, Li K. Peripheral blood indices to predict PFS/OS with anlotinib as a subsequent treatment in advanced small-cell lung cancer. Cancer Biol Med. 2021 Jul 24;19(8):1249-58. doi: 10.20892/j.issn.2095-3941.2020.0727.

    PubMed 34302324

  • Cheng Y, Wang Q, Li K, Shi J, Liu Y, Wu L, Han B, Chen G, He J, Wang J, Lou D, Yu H, Wang S, Qin H, Li X. Anlotinib vs placebo as third- or further-line treatment for patients with small cell lung cancer: a randomised, double-blind, placebo-controlled Phase 2 study. Br J Cancer. 2021 Aug;125(3):366-371. doi: 10.1038/s41416-021-01356-3. Epub 2021 May 18.

    PubMed 34006926

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib in people with Small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 12 sites 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 6 inclusion and 20 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 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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. Some participants in this study may receive a placebo. 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?

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?

Progress free survival (PFS) (time frame: From randomization，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 NCT03059797, which also lists 3 linked publications.

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 16 May 2019.

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