Lung CancerPhase 1/2NCT02321540

A Phase I/II Study of Ibrutinib in Previously Treated Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer

A Phase 1/2 study testing Ibrutinib in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

The goal of Part 1 of this clinical research study is to find the highest dose of (Imbruvica) ibrutinib that can be given to patients with non-small cell lung cancer (NSCLC). The goal of Part 2 of this clinical research study is to learn if the dose of ibrutinib found in Part 1 can help to control the disease. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer
What is being tested?: Ibrutinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited States
Study dates: 31 Mar 2015to 16 Sep 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients must have histologically or cytologically confirmed stage IV non-small cell lung cancer, or recurrent non-small cell lung cancer which is not amenable to curative intent therapy.
Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors(RECIST) 1.1 criteria
For EGFR mutant cohort, patients must have: a) Documented EGFR mutation by Clinical Laboratory Improvement Amendments (CLIA)-certified test b) Documented disease progression on treatment with erlotinib, gefitinib, afatinib, or other EGFR-targeted tyrosine kinase inhibitor c) Tissue available from a biopsy or surgical procedure performed after progression on an EGFR targeted tyrosine kinase inhibitor. If tissue is not available, the patient must have biopsy accessible disease and must be willing to undergo a biopsy.
For HER2 mutant cohort, patients must have: a) Documented EGFR mutation by CLIA-certified test b)Documented disease progression on treatment with erlotinib, gefitinib, afatinib, or other EGFR-targeted tyrosine kinase inhibitor c)Tissue available following progression on most recent systemic therapy. If tissue is not available, the patient must have biopsy accessible disease and must be willing to undergo a biopsy.
Age >/=18 years
Eastern Cooperative Oncology Group (ECOG) performance status </=2

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Ability to take pills by mouth
Patients must have normal organ and marrow function as defined: leukocytes >/= 3,000/mcL; absolute neutrophil count >/= 1,500/mcL; hemoglobin >/= 9 g/dL; total bilirubin </= 1.5 x institutional upper limit of normal (ULN); AST(SGOT)/ALT(SGPT) </= 2.5 × ULN or </= 5 x ULN if metastases to the liver; creatinine clearance >/= 45 mL/min
Patients with asymptomatic brain metastases are allowed, as long as they are stable and do not require treatment with anticonvulsants or escalating doses of steroids. Maximum daily dose of steroids should be prednisone 20 mg or equivalent. Radiation therapy for brain metastases must be completed at least 14 days prior to treatment on protocol
The effects of ibrutinib on the developing human fetus are unknown. Women of child-bearing potential and men must agree to use highly effective contraception (if using hormonal birth control must add a second barrier method; abstinence) prior to study entry, for the duration of study participation as well as for at least 1 month after the last dose of ibrutinib. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use highly effective contraception prior to the study, for the duration of study participation and 3 months after completion of ibrutinib administration.
Ability to understand and the willingness to sign a written informed consent document

Who cannot join

Patients who have received EGFR tyrosine kinase inhibitors within 72 hours of initiation of study treatment, or treatment with other anti-cancer agents within 21 days of study treatment
Prior treatment with ibrutinib
Known hypersensitivity to ibrutinib
Concurrent use of agents that strongly inhibit or induce CYP3A unless use is approved by the medical monitor
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant and nursing women

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Patients with a history of another active malignancy within the past two years, with the exception of non-melanoma cutaneous malignancy, cervical carcinoma in situ, or ductal carcinoma in situ which has been successfully treated with curative intent therapy
Any gastrointestinal disorder expected to limit absorption of ibrutinib
Treatment with warfarin or other vitamin K antagonist. Patients with using warfarin who switch to another form of anticoagulation will be eligible
Patients with persistent and uncontrolled atrial fibrillation.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas MD Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

The safety of this drug will also be studied in both parts of the study.

Read the detailed description

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 4 groups of up to 6 participants will be enrolled in Part 1 of the study, and up to19 participants will be enrolled in Part 2.

If you are enrolled in Part 1, the dose of ibrutinib you receive will depend on when you join this study. The first group of participants will receive the lowest dose level of ibrutinib. Each new group will receive a higher dose of ibrutinib than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of ibrutinib is found.

If you are enrolled in Part 2, you will receive ibrutinib at the highest dose that was tolerated in Part 1.

Study Drug Administration:

You will take ibrutinib pills 1 time each day, at about the same time every day. You may take your dose of ibrutinib with or without food.

Study Visits:

Each cycle is 4 weeks.

On Day 1 of all cycles:

You will have a physical exam
Blood (about 3 teaspoons) will be drawn for routine tests.
On Cycle 2 only, blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing before your dose and then 4 more times over the next 6 hours after your dose. PK testing measure the amount of study drug in the body at different timepoints.
If you the doctor thinks it is needed, blood (about ½ teaspoon) or urine will be collected for pregnancy testing.

Every 8 weeks, you will have a CT, MRI, or x-ray to check the status of the disease. You will have the same type of scan performed as you did at screening.

Length of Study:

You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

End-of-Dosing Visit:

About 30 days after your last dose of study drug:

You will have a physical exam.
Blood (about 3 teaspoons) will be drawn for routine tests.
If you the doctor thinks it is needed, blood (about ½ teaspoon) or urine will be collected for pregnancy testing.

Follow Up Visits:

Every 6 months you will be asked to come into the clinic or you will be called by a member of the study staff to ask how you are doing and if you have started any new anti-cancer treatments. If you are called, it should take about 10 minutes.

This is an investigational study. Ibrutinib is FDA approved and commercially available for the treatment of chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). It is considered investigational to use this drug to treat NSCLC. The study doctor can explain how the study drug is designed to work.

Up to 43 participants will be enrolled on this study. All will take part at MD Anderson.

Conditions: Lung Cancer
Being tested: Ibrutinib
Keywords: Lung Cancer, Non-small cell lung cancer, NSCLC, Epidermal growth factor receptor mutations, EGFR, Recurrent non-small cell lung cancer, Ibrutinib, PCI-32765, Imbruvica
Medical subject headings: Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

IbrutinibDrug
Also called PCI-32765, Imbruvica
Part 1 Starting level of Ibrutinib: 560 mg by mouth daily in a 28 day cycle.
Part 2 Starting level of Ibrutinib: Maximum tolerated dose from Part 1 or 840 mg daily.

Study groups in NCT02321540
Study group	Role	What they receive
Ibrutinib	Experimental	Participants in Part 1 receive dose level of Ibrutinib depending on study joined. First group of participants receive lowest dose level of Ibrutinib. Each new group receives a higher dose of Ibrutinib than the group before it, if no intolerable side effects were seen. This continues until highest tolerable dose of Ibrutinib is found. Participants in Part 2 receive Ibrutinib at highest dose that was tolerated in Part 1 or 840 mg daily. Starting level of Ibrutinib: 560 mg by mouth daily in a 28 day cycle. Receives: Drug: Ibrutinib

What is being measured

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

Number of Participants With at Least One Dose Limiting Toxicity (DLT) Observed During the Dose Escalation to Determine the Maximum Tolerated Dose (MTD)
Number of DLT observed at dose levels 560 (starting dose) and 840 mg PO daily to determine the MTD using the 3+3 design.
Measured: First cycle of 28 days
Overall Response Rate in Patients With EGFR Mutations Using RECIST
Complete response and partial resopnse rate RECIST 1.1 criteria The response was evaluated after two cycles of therapy and every 8 weeks until the first date that recurrent or progressive disease is objectively documented, up to 2 years.
Measured: after two cycles of therapy and every 8 weeks, up to 2 years

Secondary outcomes (2)

Overall Survival (OS)
Overall survival (OS) is defined as the duration of time from start of treatment to time of progression or death.
Measured: from start of treatment to time of progression or death, up to 2 years
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Measured: from start of treatment to time progression or death, whichever occurs first, up to 2 years

Timeline

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

31 Mar 201516 Sep 2021

First posted22 Dec 2014 (estimated)
Study start31 Mar 2015
Primary completion16 Sep 2021
Study completion16 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02321540
Sponsor's protocol ID: 2014-0602
Other IDs: NCI-2015-00124, 1R01CA190628
Status last verified: Sep 2023
First submitted: 17 Dec 2014
Last updated: 25 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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 Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Study of Ibrutinib in Previously Treated Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT02321540
Acronym / sponsor ID: 2014-0602
Conditions: Lung Cancer
Keywords: Lung Cancer, Non-small cell lung cancer, NSCLC, Epidermal growth factor receptor mutations, EGFR, Recurrent non-small cell lung cancer, Ibrutinib, PCI-32765
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: Pharmacyclics LLC., National Cancer Institute (NCI)
Study start: 31 Mar 2015 (actual)
Primary completion: 16 Sep 2021 (actual)
Study completion: 16 Sep 2021 (actual)
First posted: 22 Dec 2014 (estimated)
Results: Posted 25 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The safety of this drug will also be studied in both parts of the study.

Detailed description

Study Groups:

If you are enrolled in Part 2, you will receive ibrutinib at the highest dose that was tolerated in Part 1.

Study Drug Administration:

You will take ibrutinib pills 1 time each day, at about the same time every day. You may take your dose of ibrutinib with or without food.

Study Visits:

Each cycle is 4 weeks.

On Day 1 of all cycles:

You will have a physical exam
Blood (about 3 teaspoons) will be drawn for routine tests.
On Cycle 2 only, blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing before your dose and then 4 more times over the next 6 hours after your dose. PK testing measure the amount of study drug in the body at different timepoints.
If you the doctor thinks it is needed, blood (about ½ teaspoon) or urine will be collected for pregnancy testing.

Every 8 weeks, you will have a CT, MRI, or x-ray to check the status of the disease. You will have the same type of scan performed as you did at screening.

Length of Study:

Your participation on the study will be over after the follow-up visits.

End-of-Dosing Visit:

About 30 days after your last dose of study drug:

You will have a physical exam.
Blood (about 3 teaspoons) will be drawn for routine tests.
If you the doctor thinks it is needed, blood (about ½ teaspoon) or urine will be collected for pregnancy testing.

Follow Up Visits:

Up to 43 participants will be enrolled on this study. All will take part at MD Anderson.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ibrutinib	Experimental	Drug: IbrutinibParticipants in Part 1 receive dose level of Ibrutinib depending on study joined. First group of participants receive lowest dose level of Ibrutinib. Each new group receives a higher dose of Ibrutinib than the group before it, if no intolerable side effects were seen. This continues until highest tolerable dose of Ibrutinib is found. Participants in Part 2 receive Ibrutinib at highest dose that was tolerated in Part 1 or 840 mg daily. Starting level of Ibrutinib: 560 mg by mouth daily in a 28 day cycle.

Who may qualify

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

Key inclusion criteria (11 listed)

Patients must have histologically or cytologically confirmed stage IV non-small cell lung cancer, or recurrent non-small cell lung cancer which is not amenable to curative intent therapy.
Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors(RECIST) 1.1 criteria
For EGFR mutant cohort, patients must have: a) Documented EGFR mutation by Clinical Laboratory Improvement Amendments (CLIA)-certified test b) Documented disease progression on treatment with erlotinib, gefitinib, afatinib, or other EGFR-targeted tyrosine kinase inhibitor c) Tissue available from a biopsy or surgical procedure performed after progression on an EGFR targeted tyrosine kinase inhibitor. If tissue is not available, the patient must have biopsy accessible disease and must be willing to undergo a biopsy.
For HER2 mutant cohort, patients must have: a) Documented EGFR mutation by CLIA-certified test b)Documented disease progression on treatment with erlotinib, gefitinib, afatinib, or other EGFR-targeted tyrosine kinase inhibitor c)Tissue available following progression on most recent systemic therapy. If tissue is not available, the patient must have biopsy accessible disease and must be willing to undergo a biopsy.
Age >/=18 years

Key exclusion criteria (10 listed)

Patients who have received EGFR tyrosine kinase inhibitors within 72 hours of initiation of study treatment, or treatment with other anti-cancer agents within 21 days of study treatment
Prior treatment with ibrutinib
Known hypersensitivity to ibrutinib
Concurrent use of agents that strongly inhibit or induce CYP3A unless use is approved by the medical monitor
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

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
IbrutinibAlso: PCI-32765, ImbruvicaPart 1 Starting level of Ibrutinib: 560 mg by mouth daily in a 28 day cycle. Part 2 Starting level of Ibrutinib: Maximum tolerated dose from Part 1 or 840 mg daily.	Drug	Ibrutinib

Primary outcome

Number of Participants With at Least One Dose Limiting Toxicity (DLT) Observed During the Dose Escalation to Determine the Maximum Tolerated Dose (MTD)
Time frame: First cycle of 28 days
Number of DLT observed at dose levels 560 (starting dose) and 840 mg PO daily to determine the MTD using the 3+3 design.
Overall Response Rate in Patients With EGFR Mutations Using RECIST
Time frame: after two cycles of therapy and every 8 weeks, up to 2 years
Complete response and partial resopnse rate RECIST 1.1 criteria The response was evaluated after two cycles of therapy and every 8 weeks until the first date that recurrent or progressive disease is objectively documented, up to 2 years.

2 secondary outcomes

Overall Survival (OS)
Time frame: from start of treatment to time of progression or death, up to 2 years
Progression-Free Survival (PFS)
Time frame: from start of treatment to time progression or death, whichever occurs first, up to 2 years

Results and safety

Results posted to the registry on 25 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ibrutinib Dose Level 0	3	0
Ibrutinib Dose Level 1	10	0

Primary outcome: Number of Participants With at Least One Dose Limiting Toxicity (DLT) Observed During the Dose Escalation to Determine the Maximum Tolerated Dose (MTD)

Time frame: First cycle of 28 days. Count of participants. Unit: Participants

Measure	Ibrutinib Dose Level 0 (560mg) n = 3	Ibrutinib Dose Level 1 (840mg) n = 10
Value	0	0

Population analysed: 12 patients were evaluable for overall response rate; 1 patient who received 840 mg PO daily was inevaluable due to death prior to first response assessment after start of treatment.

Primary outcome: Overall Response Rate in Patients With EGFR Mutations Using RECIST

Time frame: after two cycles of therapy and every 8 weeks, up to 2 years. Count of participants. Unit: Participants

Measure	Ibrutinib Dose Level 0 (560mg) n = 3	Ibrutinib Dose Level 1 (840mg) n = 9
Value	3	9

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose through 30 days after the last dose of study medication, up to 2 years. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ibrutinib at Dose Level 0 (560 PO Daily).	0 of 3 (0%)	3 of 3 (100%)	3 of 3
Ibrutinib at Dose Level 1 (840 PO Daily).	4 of 10 (40%)	10 of 10 (100%)	10 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.

Related trials for Lung Cancer

RecruitingPhase 1/2
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
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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.

John Heymach, MD, PHD principal investigator

M.D. Anderson Cancer Center

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ibrutinib in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

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 11 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: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 25 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With at Least One Dose Limiting Toxicity (DLT) Observed During the Dose Escalation to Determine the Maximum Tolerated Dose (MTD) (time frame: First cycle of 28 days). 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?

On the ClinicalTrials.gov record for NCT02321540.

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 25 Oct 2023.