NSCLCPhase 3FALUCANCT02691299

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

A Phase 3 study testing Fruquintinib in people with NSCLC, run by Hutchison Medipharma Limited at 11 sites in China.

Completed

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

Trial summary

Fruquintinib/Placebo 5 mg, QD, orally administered under fasting conditions for 3 consecutive weeks followed by one-week off to evaluate the survival benefit of patients with advanced non-squamous NSCLC treated with Fruquintinib. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: NSCLC
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: 527 participants
Where: 11 sitesChina
Study dates: 9 Dec 2015to 16 Nov 2018
Phase: Phase 3
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 or cytologically diagnosed with local advanced and/or metastatic stage IIIB/IV non-squamous NSCLC;
Disease progressed or developed non-tolerable toxicity after 2 lines of systemic chemotherapy (not including TKI therapy); Notes: a. The first-line chemotherapy should be platinum-based doublets regimens; b. For each line of systemic therapy, at least one treatment cycle should be completed, and maintenance therapy using one of the doublets is considered as the same line of therapy; c. Previous adjuvant/neoadjuvant therapy is allowed. If disease progressed during the adjuvant/neoadjuvant therapy period or within 1 year after completion of the above treatment, it is considered that patient failed the first-line systemic chemotherapy;
Patients with EGFR genetic test negative; or positive with EGFR, test result but resistant or intolerable to related targeted therapies;
Patients with ALK test negative; or positive with ALK test result but resistant or intolerable to related targeted therapies;
Aged 18-75 years (inclusive);

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Measurable disease (according to RECIST1.1);
ECOG Performance Status score 0-1;
Life expectancy >12 weeks.

Who cannot join

Patients who have participated in another clinical trial or received systemic anti-neoplastic therapy, radiotherapy or biotherapy within 3 weeks prior to administration of the study drug; or received EGFR-TKI treatment in the past 1 week.
Patients who have previously received therapy with VEGFR inhibitors;
Patients who have not recovered from toxicity caused by previous anti-neoplastic treatment (CTCAE > grade 1), or not completely recovered from previous surgery;
Patient with active brain metastasis (untreated with proper radiation therapy, showing clinical symptoms or symptom stable time less than 4 weeks, or indicated for symptomatic treatment for brain metastasis, etc.);
Patients with other primary malignancies within the past 5 years except basal cell carcinoma of skin or carcinoma in situ of cervix;
Patients with uncontrolled active infections, e.g. acute pneumonia, active hepatitis B or active hepatitis C, etc. (for patients with a history of hepatitis B, whether treated or not, HBV DNA ≥500copies or ≥ 100IU / ml);

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Patients with dysphagia or known drug malabsorption;
Patients 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;
Patients fulfilling any of the following criteria shall be excluded:
1) Absolute neutrophil count (ANC) <1.5×109/L, platelet <100×109/L or hemoglobin <9 g/dL within 1 week prior to enrollment;
2) Serum total bilirubin > 1.5 × upper limit of normal (ULN), alanine transaminase and aspartate aminotransferase >2.5×ULN (according to reference range in each clinical study site); ALT and AST > 5×ULN in patients with liver metastasis;
3) Clinically significant electrolyte abnormality;
4) Blood creatinine > ULN and creatinine clearance <60 ml/min;
5) Urine protein 2+ or more, or urine protein quantification ≥1.0 g/24 h;
6) Activated partial thromboplastin time (APTT) or/and INR and prothrombin time (PT) > 1.5×ULN (according to reference range in each clinical study site);
10. Patients with uncontrolled hypertension, systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg after symptomatic treatment;
11. Patients with left ventricular ejection fraction <50% (echocardiography) in heart function evaluation;
12. Patients with acute myocardial infarction, severe/unstable angina or coronary bypass surgery within 6 months prior to enrollment; cardiac insufficiency of NYHA II or above;
13. Patients who have a history of arterial thrombosis or deep venous thrombosis within 6 months prior to enrollment, history or evidence of thrombosis or bleeding tendency regardless of the severity within 2 months prior to enrollment; history of hemoptysis (i.e. coughing blood in bright red color or at least 1/2 teaspoon) within 2 weeks prior to enrollment;
14. Patients who have a history of stroke and/or transient ischemic attack within 12 months prior to enrollment;
15. Patients with skin wound, surgical site, wound site, severe mucosal ulcer or fracture without complete healing;
16. Pregnant or lactating women, or women of child bearing potential with positive pregnancy test result before the first dose;
17. Patients with child bearing potential who or whose sexual partners are not willing to take contraceptive measures;
18. Patients with any clinical or laboratory abnormalities unsuitable for participating in this clinical trial according to the investigator's judgment;
19. Patients with serious psychological or psychiatric disorders which may affect subject compliance in this clinical study;
20. Patients who are allergic to analogue of Fruquintinib and/or its inactive ingredients.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

China11 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
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 III Clinical Trial in Patients With Advanced Non-squamous Non-small Cell Lung Cancer Treated With Fruquintinib

Read the detailed description

This is a randomized, double-blind, placebo-controlled, multi-center Phase III clinical trial in patients with advanced non-squamous non-small cell lung cancer (NSCLC) treated with Fruquintinib who failed 2 lines of systemic chemotherapy or with non-tolerable toxicities.

Approximately 521 subjects will be randomized to Fruquintinib group or placebo group at a ratio of 2:1. Patients in the two groups can receive supportive treatment.

Randomization will be stratified by EGFR gene status (mutant vs. wild type) and history of treatment by VEGF inhibitors (yes vs no) .

All subjects will receive study treatment in 4-week cycles: Fruquintinib/placebo for 3 consecutive weeks, and then one week off. Tumor assessment will be performed every 4 weeks in the first 2 cycles, and every 8 weeks since the 3rd cycle, until disease progression or death. Subsequent anti-neoplastic treatment and survival status will be followed up after disease progression.

Conditions: NSCLC
Being tested: Fruquintinib, Placebo
Keywords: NSCLC

What participants receive

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

FruquintinibDrug
Also called HMPL-013
Fruquintinib is a capsule in the form of 5mg and 1mg, orally once daily. 3 weeks on/1 week off
PlaceboDrug
Also called HMPL-013 placebo
Placebo is a capsule in the form of 5mg and 1mg, orally once daily. 3 weeks on/1 week off

Study groups in NCT02691299
Study group	Role	What they receive
Treatment Arm	Active comparator	All subjects will receive study treatment in 4-week cycles: Fruquintinib, QD, 5mg with best supportive care for 3 consecutive weeks, and then one week off. Tumor assessment will be performed every 4 weeks in the first 2 cycles, and every 8 weeks since the 3rd cycle, until disease progression or death. Subsequent anti-neoplastic treatment and survival status will be followed up after disease progression. Receives: Drug: Fruquintinib
Control Arm	Placebo comparator	All subjects will receive study treatment in 4-week cycles: Placebo, QD, 5mg with best supportive care for 3 consecutive weeks, and then one week off. Tumor assessment will be performed every 4 weeks in the first 2 cycles, and every 8 weeks since the 3rd cycle, until disease progression or death. Subsequent anti-neoplastic treatment and survival status will be followed up after disease Receives: Drug: Placebo

What is being measured

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

overall survival (OS)
Duration from randomization to death from any cause
Measured: From the date of randomization until the date of death from any cause, Assessed up to 15 months

Secondary outcomes (5)

Objective Response Rate (ORR)
Occurence of completed response or partial response after treatment, assessed by RECIST 1.1
Measured: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 12 months
progression free survival (PFS)
The duration from randomization to first documented progression or death from any cause, whichever came first, assessed by RECIST 1.1
Measured: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 12 months
Disease Control Rate (DCR)
Occurence of completed response, or partial response, or stable disease, assessed by RECIST 1.1
Measured: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 12 months
duration of response (DOR)
Duration from first documented completed response or partial response to first documented progression or death from any cause, whichever came first
Measured: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 12 months
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 4.03
Measured: From randomization to 30 days after last dose, assessed up to 13 months

Timeline

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

9 Dec 201516 Nov 2018

First posted25 Feb 2016 (estimated)
Study start9 Dec 2015
Primary completion21 Sep 2018
Study completion16 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for NSCLCStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 527 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02691299
Sponsor's protocol ID: 2015-013-00CH1
Acronym: FALUCA
Status last verified: Feb 2019
First submitted: 18 Feb 2016
Last updated: 12 Feb 2019
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All NSCLC trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Clinical Trial in Patients With Advanced Non-squamous Non-small Cell Lung Cancer Treated With Fruquintinib
ClinicalTrials.gov ID: NCT02691299
Acronym / sponsor ID: FALUCA / 2015-013-00CH1
Conditions: NSCLC
Keywords: NSCLC
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 527 participants (actual)
Lead sponsor: Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
Study start: 9 Dec 2015 (actual)
Primary completion: 21 Sep 2018 (actual)
Study completion: 16 Nov 2018 (actual)
First posted: 25 Feb 2016 (estimated)
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.

Detailed description

Approximately 521 subjects will be randomized to Fruquintinib group or placebo group at a ratio of 2:1. Patients in the two groups can receive supportive treatment.

Randomization will be stratified by EGFR gene status (mutant vs. wild type) and history of treatment by VEGF inhibitors (yes vs no) .

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Treatment Arm	Active comparator	Drug: FruquintinibAll subjects will receive study treatment in 4-week cycles: Fruquintinib, QD, 5mg with best supportive care for 3 consecutive weeks, and then one week off. Tumor assessment will be performed every 4 weeks in the first 2 cycles, and every 8 weeks since the 3rd cycle, until disease progression or death. Subsequent anti-neoplastic treatment and survival status will be followed up after disease progression.
Control Arm	Placebo comparator	Drug: PlaceboAll subjects will receive study treatment in 4-week cycles: Placebo, QD, 5mg with best supportive care for 3 consecutive weeks, and then one week off. Tumor assessment will be performed every 4 weeks in the first 2 cycles, and every 8 weeks since the 3rd cycle, until disease progression or death. Subsequent anti-neoplastic treatment and survival status will be followed up after disease

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Fully understand the study and sign the informed consent form voluntarily;
Histologically or cytologically diagnosed with local advanced and/or metastatic stage IIIB/IV non-squamous NSCLC;
Disease progressed or developed non-tolerable toxicity after 2 lines of systemic chemotherapy (not including TKI therapy); Notes: a. The first-line chemotherapy should be platinum-based doublets regimens; b. For each line of systemic therapy, at least one treatment cycle should be completed, and maintenance therapy using one of the doublets is considered as the same line of therapy; c. Previous adjuvant/neoadjuvant therapy is allowed. If disease progressed during the adjuvant/neoadjuvant therapy period or within 1 year after completion of the above treatment, it is considered that patient failed the first-line systemic chemotherapy;
Patients with EGFR genetic test negative; or positive with EGFR, test result but resistant or intolerable to related targeted therapies;
Patients with ALK test negative; or positive with ALK test result but resistant or intolerable to related targeted therapies;

Key exclusion criteria (26 listed)

Patients who have participated in another clinical trial or received systemic anti-neoplastic therapy, radiotherapy or biotherapy within 3 weeks prior to administration of the study drug; or received EGFR-TKI treatment in the past 1 week.
Patients who have previously received therapy with VEGFR inhibitors;
Patients who have not recovered from toxicity caused by previous anti-neoplastic treatment (CTCAE > grade 1), or not completely recovered from previous surgery;
Patient with active brain metastasis (untreated with proper radiation therapy, showing clinical symptoms or symptom stable time less than 4 weeks, or indicated for symptomatic treatment for brain metastasis, etc.);
Patients with other primary malignancies within the past 5 years except basal cell carcinoma of skin or carcinoma in situ of cervix;

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
FruquintinibAlso: HMPL-013Fruquintinib is a capsule in the form of 5mg and 1mg, orally once daily. 3 weeks on/1 week off	Drug	Treatment Arm
PlaceboAlso: HMPL-013 placeboPlacebo is a capsule in the form of 5mg and 1mg, orally once daily. 3 weeks on/1 week off	Drug	Control Arm

Primary outcome

overall survival (OS)
Time frame: From the date of randomization until the date of death from any cause, Assessed up to 15 months
Duration from randomization to death from any cause

5 secondary outcomes

Objective Response Rate (ORR)
Time frame: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 12 months
progression free survival (PFS)
Time frame: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 12 months
Disease Control Rate (DCR)
Time frame: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 12 months
duration of response (DOR)
Time frame: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 12 months
safety and tolerability by incidence, severity and outcome of adverse events
Time frame: From randomization to 30 days after last dose, assessed up to 13 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
Individual participant dataSharing planned: Undecided

Related trials for NSCLC

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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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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.

Songhua Fan, M.D. study director

HMP MediPharma Ltd.

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fruquintinib in people with NSCLC, run by Hutchison Medipharma Limited at 11 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 9 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 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

overall survival (OS) (time frame: From the date of randomization until the date of death from any cause, Assessed up to 15 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 NCT02691299.

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 12 Feb 2019.