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Non-small Cell Lung CancerPhase 2NCT02590965

A Clinical Trial of Fruquintinib in Patients With Advanced Non-small Cell Lung Cancer

A Phase 2 study testing Fruquintinib in people with Non-small Cell Lung Cancer, run by Hutchison Medipharma Limited 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

This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial to evaluate the efficacy and safety of Fruquintinib plus best supportive care in patients with advanced non-squamous non-small cell lung cancer who failed to second-line standard chemotherapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Fruquintinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
91 participants
Where
12 sitesChina
Study dates
29 May 2014to 10 Feb 2017
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

  • Fully understand the study and sign the informed consent form voluntarily;
  • Histologically and/or cytologically diagnosed with local advanced and/or metastatic stage IIIB/IV non-squamous NSCLC;
  • Previously failed to two chemotherapy regimens(treatment failure is defined as disease progression or intolerable toxicity), patients with positive EGFR mutation permitted to treated by EGFR-TKI previously; patients with EGFR wild type or unknown whether or not treated by EGFR-TKI previously;
  • Aged 18-75 years (inclusive);
  • Body weight ≥40 kg;
  • Evident measurable lesion(s) (according to RECIST1.1);
  • ECOG Performance Status 0-1;
  • Expected survival >12 weeks

Who cannot join

  • Treatment in another clinical trials in the past 3 weeks; or treatment with systemic anti-tumor chemotherapy, radiotherapy or biotherapy within 3 weeks prior to administration of the study drug;
  • Previous therapy with VEGF/VEGFR inhibitors;
  • Unrecovered from toxicity caused by previous anti-cancer treatment (CTCAE >grade 1), or not completely recovered from previous surgery;
  • Previous active brain metastasis (without radiotherapy previously, or symptoms stable < 4 weeks, or with clinical symptoms, or with medication to control symptoms);
  • Other malignancies except basal cell carcinoma or cervical carcinoma in situ in the past 5 years;
  • Uncontrolled clinical active infection, e.g. acute pneumonia and active hepatitis B;
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  • Dysphagia or known drug malabsorption;
  • Present active duodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions that may lead to gastrointestinal bleeding or perforation according to the investigators' judgment; or with a history of intestinal perforation or intestinal fistula;
  • Have evidence or a history of thrombosis or bleeding tendency, regardless of seriousness;
  • Stroke and/or transient ischemic attack within 12 months prior to enrollment;
  • Appropriate organ function. Patients with any of the following conditions will be excluded:
  • Absolute neutrophil count (ANC) <1.5×109/L, platelet <100×109/L or hemoglobin <9 g/dL within 1 week prior to enrollment;
  • Serum total bilirubin >1.5 upper limit of normal (ULN), alanine transaminase and aspartate transferase >1.5×ULN; ALT and AST > 3×ULN in patients with liver metastasis;
  • Electrolyte abnormality of clinical significance;
  • Blood creatinine >ULN and creatinine clearance <60 ml/min;
  • Urine protein 2+ or above, or 24 h urine protein quantification ≥1.0 g/24 h;
  • Activated partial thromboplastin time (APTT) or/and INR and prothrombin time (PT) >1.5×ULN (according to reference range in each clinical study center);
  • Uncontrolled hypertension, systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg with medication; or heart failure NYHA classification ≥ grade 2;
  • Heart function evaluation: left ventricular ejection fraction <50% (echocardiography);
  • Acute myocardial infarction, severe/unstable angina or coronary bypass surgery within 6 months prior to enrollment; history of arterial thrombosis or deep venous thrombosis;
  • Skin wound, surgical site, wound site, severe mucosal ulcer or fracture without complete healing;
  • Female subjects who are pregnant or lactating or of child bearing potential with positive pregnancy test result before the first dose;
  • Patients with child bearing potential who or whose sexual partners are not willing to take contraceptive measures;
  • Any clinical or laboratory abnormalities unfit to participate in this clinical trial according to the investigator's judgment;
  • Serious psychological or psychiatric disorders which may affect subject compliance in this clinical study;
  • Allergy to Fruquintinib and/or excipient contained in trial drugs.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • 307 Hospital of PLA

    Beijing, Beijing Municipality, 100071

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Beijing Chest Hospital

    Beijing, Beijing Municipality, 101149

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • West China Hospital

    Chengdu, Sichuan, 610041

  • Xi Nan Hospital, Third Military Medical University

    Chongqing, Chongqing Municipality, 400038

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hosptial of College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • Linyi Tumor Hospital

    Linyi, Shandong, 276001

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226000

  • The Cancer Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200000

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Clinical Trial to Evaluate the Efficacy and Safety of Fruquintinib Plus Best Supportive Care in Patients With Advanced Non-squamous Non-small Cell Lung Cancer

This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial to evaluate the efficacy and safety of Fruquintinib plus best supportive care in patients with advanced non-squamous non-small cell lung cancer who failed to second-line standard chemotherapy.

Read the detailed description

Approximately 90 subjects will be randomized to Fruquintinib plus best supportive care or placebo plus best supportive care at a 2:1 ratio.

Randomization will be stratified by EGFR (epidermal growth factor receptor) gene status: mutant vs. wild type vs. unknown.

All subjects will receive Fruquintinib/placebo for consecutive 3 weeks, followed by one-week rest. A treatment cycle consists of 4 weeks. Tumor assessment will be performed every 4 weeks in the first 3 cycles, and every 8 weeks since the 4th cycle, until disease progression. Further treatment and survival follow-up after progression will be recorded.

Being tested
Fruquintinib, Placebo
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • FruquintinibDrug

    Also called HMPL-013

    After checking eligibility criteria, subjects will be randomized into Fruquintinib plus best supportive care group (treatment group) or placebo plus best supportive care group (control group) in a ration of 2:1.

  • PlaceboDrug

    Also called HMPL-013-placebo

    Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/1 week off

Study groups in NCT02590965
Study groupRoleWhat they receive
Control GroupPlacebo comparatorPlacebo is a capsule in the form of 1mg and 5 mg, orally, once daily, 3 weeks on/1week off with best supportive care.
Receives: Drug: Placebo
Treatment GroupExperimentalThe subjects will receive oral Fruquintinib at fasting state 5mg+best supportive care, once daily for the first 3 consecutive weeks and dose holiday for 1 week according to their dose regimens until the occurrence of disease progression, unacceptable toxicity, or withdrawal of consent
Receives: Drug: Fruquintinib

What is being measured

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

  1. Progressive free survival (PFS)

    To compare the Progressive Free Survival (PFS) of Fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients advanced non-squamous NSCLC patients who failed to standard second-line chemotherapy according to RECIST 1.1

    Measured: measured every 4 weeks at first 2 cycles and every 8 weeks since the third cycle from randomization to disease progression, assessed up to one year

Secondary outcomes (4)

  1. Objective response rate (ORR)

    To evaluate objective response rate (ORR) in the two groups according to RECIST 1.1

    Measured: measured every 4 weeks at first 2 cycles and every 8 weeks since the third cycle from randomization to disease progression, assessed up to one year

  2. Disease control rate (DCR)

    To evaluate disease control rate (DCR) in the two groups according to RECIST 1.1

    Measured: measured every 4 weeks at first 2 cycles and every 8 weeks since the third cycle from randomization to disease progression, assessed up to one year

  3. Overall survival (OS)

    To evaluate overall survival (OS) in the two groups

    Measured: every 2 months from randomization to death, assessed up to one year

  4. safety and tolerability by incidence, severity and outcome of adverse events

    To evaluate the safety and tolerability in the two groups by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0.

    Measured: From randomization to 30 days after last dose

Timeline

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

  1. First posted29 Oct 2015 (estimated)
  2. Study start29 May 2014
  3. Primary completion7 Aug 2015
  4. Study completion10 Feb 2017

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
Double blind
Who is masked
Participant, Investigator
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02590965
Sponsor's protocol ID
2014-013-00CH1
Status last verified
Feb 2020
First submitted
26 Mar 2015
Last updated
13 Feb 2020
Results posted
No
Data monitoring committee
No

Publications

  • Lu S, Chang J, Liu X, Shi J, Lu Y, Li W, Yang JJ, Zhou J, Wang J, An T, Yang L, Liu Z, Zhou X, Chen M, Hua Y, Su W. Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study of Fruquintinib After Two Prior Chemotherapy Regimens in Chinese Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Apr 20;36(12):1207-1217. doi: 10.1200/JCO.2017.76.7145. Epub 2018 Mar 12.

    PubMed 29528793

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fruquintinib in people with Non-small Cell Lung Cancer, run by Hutchison Medipharma Limited 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 8 inclusion and 26 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 13 Feb 2020. 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?

Progressive free survival (PFS) (time frame: measured every 4 weeks at first 2 cycles and every 8 weeks since the third cycle from randomization to disease progression, assessed up to one year). 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 NCT02590965, 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 13 Feb 2020.

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