NSCLCPhase 2NCT02976116
A Phase II Study of Fruquintinib in Combination With Gefitinib in Patients With Advanced Non-small Cell Lung Cancer
A Phase 2 study testing Fruquintinib and Gefitinib in people with NSCLC, run by Hutchison Medipharma Limited at 2 sites in China.
Trial summary
Fruquintinib in combination with Gefitinib as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring activating EGFR mutations : a single-arm, multicenter, phase II study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Fruquintinib and Gefitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2016to 28 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form.
- Age between 18 to 75 years old.
- Histologically or cytological documented stage IIIB/IV non-squamous non-small cell lung cancer patients who have never received systematic treatment for the late-stage disease.
- ECOG 0-1
- Patients must have measurable lesions
Who cannot join
- Prior systematic treatment for the advanced NSCLC
- Absolute neutrophil count (ANC) < 1.5×10^9 /L, or platelet count < 100 ×10^9/L, or hemoglobin < 9 g/dL
- Total bilirubin > 1 ULN; SGOT (AST), SGPT (ALT), > 1.5 ULN; for patient with liver metastasis，AST or ALT > 3 ULN
- Known HIV positive
- Hypersensitivity to either of the investigation drugs
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Hospital of Zhejiang University
Hangzhou
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
About this study
Official title: Fruquintinib in Combination With Gefitinib as First-line Therapy in Patients With Advanced Non-squamous Non-small-cell Lung Cancer Harboring Activating EGFR Mutations : a Single-arm, Multicenter, Phase II Study
Fruquintinib in combination with Gefitinib as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring activating EGFR mutations : a single-arm, multicenter, phase II study
Read the detailed description
This phase II trial will evaluate the combination of fruquintinib and gefitinib in advanced NSCLC. The endpoint will be to evaluate the efficacy and safety of the combination.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FruquintinibDrug
Also called HMP-013
Fruquintinib will be administered orally once daily from Day 1 to Day 21 per 28-day cycle until disease progression or unacceptable toxicity
GefitinibDrug
Also called Iressa
Gefitinib will be administered orally once daily per 28-day cycle or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib & Gefitinib | Experimental | Drug: Fruquintinib and Gefitinib Receives: Drug: Fruquintinib; Drug: Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor objective response rate
Occurrence of completed response or partial response after treatment, assessed by RECIST 1.1
Measured: Patients will be followed until study completion, an average of 1 year
Safety and tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Measured: Each patient will be followed for 30 days after the last dose
Secondary outcomes (4)
Progression-free survival (PFS)
The duration from first dose to first documented progression or death from any cause, whichever came first, assessed by RECIST 1.1
Measured: Patients will be followed until study completion, an average of 1 year
Duration control rate (DCR)
Occurrence of completed response, or partial response, or stable disease, assessed by RECIST 1.1
Measured: Patients will be followed until study completion, an average of 1 year
Time to response (TTR)
the period from the date of first dose to the date when the criteria for complete response or partial response was first measured
Measured: Patients will be followed until study completion, an average of 1 year
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: Patients will be followed until study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startDec 2016
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongyan Yin, Study director, Hutchison MediPharma Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976116
- Sponsor's protocol ID
- 2016-013-00CH1
- Status last verified
- Aug 2019
- First submitted
- 17 Nov 2016
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fruquintinib in Combination With Gefitinib as First-line Therapy in Patients With Advanced Non-squamous Non-small-cell Lung Cancer Harboring Activating EGFR Mutations : a Single-arm, Multicenter, Phase II Study
- ClinicalTrials.gov ID
- NCT02976116
- Acronym / sponsor ID
- 2016-013-00CH1
- Conditions
- NSCLC
- Keywords
- Fruquintinib, NSCLC, 1st line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 29 Nov 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.
Fruquintinib in combination with Gefitinib as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring activating EGFR mutations : a single-arm, multicenter, phase II study
Detailed description
This phase II trial will evaluate the combination of fruquintinib and gefitinib in advanced NSCLC. The endpoint will be to evaluate the efficacy and safety of the combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib & Gefitinib | Experimental | Drug: Fruquintinib, Drug: GefitinibDrug: Fruquintinib and Gefitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed Informed Consent Form.
- Age between 18 to 75 years old.
- Histologically or cytological documented stage IIIB/IV non-squamous non-small cell lung cancer patients who have never received systematic treatment for the late-stage disease.
- ECOG 0-1
- Patients must have measurable lesions
Key exclusion criteria (5 listed)
- Prior systematic treatment for the advanced NSCLC
- Absolute neutrophil count (ANC) < 1.5×10^9 /L, or platelet count < 100 ×10^9/L, or hemoglobin < 9 g/dL
- Total bilirubin > 1 ULN; SGOT (AST), SGPT (ALT), > 1.5 ULN; for patient with liver metastasis，AST or ALT > 3 ULN
- Known HIV positive
- Hypersensitivity to either of the investigation drugs
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: HMP-013Fruquintinib will be administered orally once daily from Day 1 to Day 21 per 28-day cycle until disease progression or unacceptable toxicity | Drug | Fruquintinib & Gefitinib |
| GefitinibAlso: IressaGefitinib will be administered orally once daily per 28-day cycle or unacceptable toxicity | Drug | Fruquintinib & Gefitinib |
Primary outcome
tumor objective response rate
Time frame: Patients will be followed until study completion, an average of 1 year
Occurrence of completed response or partial response after treatment, assessed by RECIST 1.1
Safety and tolerability
Time frame: Each patient will be followed for 30 days after the last dose
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
4 secondary outcomes
Progression-free survival (PFS)
Time frame: Patients will be followed until study completion, an average of 1 year
Duration control rate (DCR)
Time frame: Patients will be followed until study completion, an average of 1 year
Time to response (TTR)
Time frame: Patients will be followed until study completion, an average of 1 year
Duration of response （DoR）
Time frame: Patients will be followed until study completion, an average of 1 year
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 15 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Hongyan Yin study director
Hutchison MediPharma Ltd
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fruquintinib and Gefitinib in people with NSCLC, run by Hutchison Medipharma Limited at 2 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 5 inclusion and 5 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 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
tumor objective response rate (time frame: Patients will be followed until study completion, an average of 1 year). 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?
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 Nov 2019.