NSCLCPhase 2/3NCT02387086

Gefitinib Combined With Thalidomide to Treat NSCLC

A Phase 2/3 study testing Thalidomide, Gefitinib and Aspirin in people with NSCLC, run by Bai Jun.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

The purpose of this study is to determine whether thalidomide can improve the effectiveness of the gefitinib in NSCLC patients with EGFR mutations. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: NSCLC
What is being tested?: Thalidomide, Gefitinib and Aspirin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 380 participants
Where: No sites listed yet
Study dates: May 2015to May 2017
Phase: Phase 2/3
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

Patients must be NSCLC confirmed by Histological or cytological;
The NSCLC harbors EGFR-mutation and are previously untreated
Patient must have measurable lesion and in stage IIIB or IV disease (includes M1a, M1b stages or recurrent disease) (according to the 7th edition of the tumor node metastasis (TNM) classification system).
Patients be age >18 years and < 75 years.
Patients must have a Life Expectancy of greater than 12 weeks.
Patients must have an ECOG performance status 0 to 2.

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Patients must have normal organ and marrow function as defined below, within one week prior to randomization: absolute neutrophil count>1,500/mL platelets>100,000/mL total bilirubin: within normal institutional limits AST/ALT<2.5X institutional upper limit of normal creatinine≤1.5X institutional upper limit of normal urine dipstick for proteinuria of < less than 1+. If urine dipstick is > 1+ then a 24 hour urine for protein must demonstrate <500mg of protein in 24 hours to allow participation in the study.
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Patients must have an international normalized ratio (INR) < 1.5 and a partial thromboplastin time (PTT) no greater than upper limits of normal within 1 week prior to randomization.
Patients with a history of hypertension must be well-controlled (<150 systolic/<100 diastolic) on a stable regimen of anti-hypertensive therapy.
Patients must be able to swallow tablets.
Patients must have the ability to understand and the willingness to sign a written informed consent document.

Who cannot join

Patients with uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
Patients receiving therapeutic anticoagulation. Prophylactic anticoagulation of venous access devices is allowed provided Section 3.10 is met. Caution should be taken on treating patients with low dose heparin or low molecular weight heparin for DVT prophylaxis during treatment with bevacizumab as there may be an increased risk of bleeding.
Patients cannot administer aspirin for the risk of bleeding or having stomach ulcers.
Prior use of chemotherapy.
Patients receiving immunotherapy, hormonal-therapy and or radiotherapy within 2 weeks prior to entering the study. Note: Those who have not recovered from adverse events due to these agents administered will be considered ineligible.
Patients receiving any other investigational agents.

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Patients with uncontrolled brain metastasis. Note: Patients with brain metastases must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks, and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to thalidomide、gefitinib and aspirin or other agents used in the study are excluded.
Women that are pregnant or breastfeeding Note: Pregnant women are excluded from this study because the agents used in this study may be teratogenic to a fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with thalidomide, breastfeeding women are also excluded from this study.
HIV-positive Patients that are on combination antiretroviral therapy due to the potential for lethal infections when treated with marrow-suppressive therapy.

Trial locations and contacts

No sites are listed yet.

Jun Bai contact

Yu Lei contact

About this study

Official title: A Phase III, Multi Center, Randomized, Placebo Controlled Study to Evaluate the Efficacy of the Combination Gefitinib With Thalidomide in Patients With Locally Advanced and Metastatic Non-Small-Cell-Lung-Cancer With EGFR Mutation

The purpose of this study is to determine whether thalidomide can improve the effectiveness of the gefitinib in NSCLC patients with EGFR mutations.

Read the detailed description

Primary Objective:

To determine the 1 year progression-free survival(PFS) rate of the combination of thalidomide with gefitinib in patients who harbors EGFR mutations.

Secondary Objectives:

To evaluate the objective response rate and 2 years overall survival of this combination therapy;
To evaluate the safety and tolerability of this combination therapy;
To acquire preliminary data regarding the effects of thalidomide on interleukin-2 level in serum.

Treatment will be administered on an outpatient basis. Thalidomide starting at a dose of 50mg QD at night. After one week, increase the dose to 100mg QD at night.

Aspirin will be administered at 100mg QD continuously. Gefitinib will be administered at 250mg QD continuously. Maintenance Therapy patients responding to this therapy will be maintained with gefitinib、thalidomide and aspirin.

Duration of Therapy

In the absence of treatment delays due to adverse events, treatment may continue until one of the following criteria applies:

Disease progression,
Intercurrent illness that prevents further administration of treatment,
Unacceptable adverse events(s),
Patient decides to withdraw from the study, or
General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.

Conditions: NSCLC
Being tested: Thalidomide, placebo, Gefitinib, Aspirin
Keywords: gefitinib, thalidomide, NSCLC, EGFR mutation

What participants receive

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

ThalidomideDrug
placeboDrug
GefitinibDrug
AspirinDrug

Study groups in NCT02387086
Study group	Role	What they receive
A:gefitinib and thalidomide/aspirin	Experimental	intervention: drug: gefitinib and thalidomide/aspirin: gefitinib will be administered at 250mg QD continuously; thalidomide will be administered at 100mg QD at night continuously; aspirin will be administered at 100mg QD continuously; Receives: Drug: Thalidomide; Drug: Gefitinib; Drug: Aspirin
B:Placebo	Placebo comparator	intervention: drug: gefitinib and placebo/aspirin: gefitinib will be administered at 250mg QD continuously; placebo will be given to patients in the same way as the thalidomide; aspirin will be administered at 100mg QD continuously; Receives: Drug: placebo; Drug: Gefitinib; Drug: Aspirin

What is being measured

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

progression-free survival (PFS)
one year progression-free survival of the patients
Measured: 1 year

Secondary outcomes (2)

Objective Response Rate (ORR)
the Objective Response Rate
Measured: 2 years
Overall Survival (OS)
2 years Overall Survival
Measured: 2 years

Timeline

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

May 2015May 2017

First posted12 Mar 2015 (estimated)
Study startMay 2015
Primary completionMay 2017 (estimated)
Study completionMay 2017 (estimated)

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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 380 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02387086
Sponsor's protocol ID: GELI
Status last verified: Mar 2015
First submitted: 3 Mar 2015
Last updated: 12 Mar 2015
Results posted: No
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multi Center, Randomized, Placebo Controlled Study to Evaluate the Efficacy of the Combination Gefitinib With Thalidomide in Patients With Locally Advanced and Metastatic Non-Small-Cell-Lung-Cancer With EGFR Mutation
ClinicalTrials.gov ID: NCT02387086
Acronym / sponsor ID: GELI
Conditions: NSCLC
Keywords: gefitinib, thalidomide, NSCLC, EGFR mutation
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 380 participants (estimated)
Lead sponsor: Bai JunUniversity, hospital or other
Study start: May 2015
Primary completion: May 2017 (estimated)
Study completion: May 2017 (estimated)
First posted: 12 Mar 2015 (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.

The purpose of this study is to determine whether thalidomide can improve the effectiveness of the gefitinib in NSCLC patients with EGFR mutations.

Detailed description

Primary Objective:

To determine the 1 year progression-free survival(PFS) rate of the combination of thalidomide with gefitinib in patients who harbors EGFR mutations.

Secondary Objectives:

To evaluate the objective response rate and 2 years overall survival of this combination therapy;
To evaluate the safety and tolerability of this combination therapy;
To acquire preliminary data regarding the effects of thalidomide on interleukin-2 level in serum.

Treatment will be administered on an outpatient basis. Thalidomide starting at a dose of 50mg QD at night. After one week, increase the dose to 100mg QD at night.

Duration of Therapy

In the absence of treatment delays due to adverse events, treatment may continue until one of the following criteria applies:

Disease progression,
Intercurrent illness that prevents further administration of treatment,
Unacceptable adverse events(s),
Patient decides to withdraw from the study, or
General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.

Study design

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

Arm	Type	Receives
A:gefitinib and thalidomide/aspirin	Experimental	Drug: Thalidomide, Drug: Gefitinib, Drug: Aspirinintervention: drug: gefitinib and thalidomide/aspirin: gefitinib will be administered at 250mg QD continuously; thalidomide will be administered at 100mg QD at night continuously; aspirin will be administered at 100mg QD continuously;
B:Placebo	Placebo comparator	Drug: placebo, Drug: Gefitinib, Drug: Aspirinintervention: drug: gefitinib and placebo/aspirin: gefitinib will be administered at 250mg QD continuously; placebo will be given to patients in the same way as the thalidomide; aspirin will be administered at 100mg QD continuously;

Who may qualify

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

Key inclusion criteria (12 listed)

Patients must be NSCLC confirmed by Histological or cytological;
The NSCLC harbors EGFR-mutation and are previously untreated
Patient must have measurable lesion and in stage IIIB or IV disease (includes M1a, M1b stages or recurrent disease) (according to the 7th edition of the tumor node metastasis (TNM) classification system).
Patients be age >18 years and < 75 years.
Patients must have a Life Expectancy of greater than 12 weeks.

Key exclusion criteria (10 listed)

Patients with uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
Patients receiving therapeutic anticoagulation. Prophylactic anticoagulation of venous access devices is allowed provided Section 3.10 is met. Caution should be taken on treating patients with low dose heparin or low molecular weight heparin for DVT prophylaxis during treatment with bevacizumab as there may be an increased risk of bleeding.
Patients cannot administer aspirin for the risk of bleeding or having stomach ulcers.
Prior use of chemotherapy.
Patients receiving immunotherapy, hormonal-therapy and or radiotherapy within 2 weeks prior to entering the study. Note: Those who have not recovered from adverse events due to these agents administered will be considered ineligible.

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
Thalidomide	Drug	A:gefitinib and thalidomide/aspirin
placebo	Drug	B:Placebo
Gefitinib	Drug	A:gefitinib and thalidomide/aspirin, B:Placebo
Aspirin	Drug	A:gefitinib and thalidomide/aspirin, B:Placebo

Primary outcome

progression-free survival (PFS)
Time frame: 1 year
one year progression-free survival of the patients

2 secondary outcomes

Objective Response Rate (ORR)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2015.

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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.

Jun Bai contact

Yu Lei contact

Jun Bai principal investigator

Shaanxi Provincial People's Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Thalidomide, Gefitinib and Aspirin in people with NSCLC, run by Bai Jun.

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 12 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 12 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jun Bai (+86-13186055863, baijun@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival (PFS) (time frame: 1 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 NCT02387086.

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 Mar 2015.