Non Small Cell Lung CancerPhase 1NCT04541407
Temodar Plus Tyrosine Kinase Inhibitors for Progressive CNS Disease
A Phase 1 study testing Temozolomide plus Osimertinib and Temozolomide plus Lorlatinib in people with Non Small Cell Lung Cancer and CNS Progression, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This trial is testing two novel combinations (temozolomide plus osimertinib OR temozolomide plus lorlatinib) which have not been evaluated in clinical trials. Thus, the exact benefits of these novel combinations are unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, CNS Progression
- What is being tested?
- Temozolomide plus Osimertinib and Temozolomide plus Lorlatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2020to 7 Jun 2022
- Phase
- Phase 1
- 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
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Male or female subject ≥ 18 years old
- ECOG performance status 0-2
- Stage IV NSCLC with progression of disease in the CNS on osimertinib 80 mg daily for patients with EGFR activating mutations (EGFR exon 19 deletions or EGFR L858R exon 21 point mutations) -OR- Stage IV NSCLC with progression of disease in the CNS on lorlatinib 100 mg daily for patients with ALK fusions
- Evaluable CNS disease is required, measurable CNS disease is not required
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- Patients who are on corticosteroids must be on stable or decreasing doses of corticosteroids for at least 14 days.
- Adequate hematologic function defined as:
- ANC ≥ 1.5 x 10^9/L
- Hemoglobin ≥ 9 g/dL
- Platelets ≥ 150 x 10^9/L
- Adequate hepatic function defined as:
- Total bilirubin ≤1.5 x upper limit of normal (ULN). For subjects with Gilbert's Disease, Total bilirubin ≤3 x ULN
- ALT and AST ≤3 x ULN. For subjects with documented liver metastases, ALT and AST ≤5×ULN
- Adequate renal function defined as:
- Estimated glomerular filtration rate (eGFR) ≥ 40 mL/minute as determined using the Cockcroft-Gault formula
- Patients must be capable of taking oral medication and have no known gastrointestinal malabsorption disorder.
- Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.
- Brain MRI with contrast is required to have demonstrated progressive CNS disease or an LP with cytology is required to have demonstrated progressive leptomeningeal disease on osimertinib or lorlatinib within 21 days of starting study drugs. CT of brain with contrast can be used to demonstrate progressive disease if patients have a documented anaphylaxis to gadolinium contrast and/or other contraindication to MRI (e.g., severe claustrophobia that cannot be managed with anxiolytics).
- Patients must not be pregnant. Women/men of reproductive potential must have agreed to use an effective contraceptive method (see section 6.6 for list of effective methods). Women must use an effective contraceptive method during the study and for 6 months following the last dose. Men having sex with women of reproductive potential are required to use effective contraception during the study and for 6 months following the last dose. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" (see section 6.6 for list of effective contraceptive methods) also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a sideeffect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Women of reproductive potential are not to be nursing during the study and for six months following the last dose of all study drugs.
- Women on the lorlatinib arm who are of reproductive potential agree to use a non-hormonal method of contraception during the study and for the time periods outlined above.
Who cannot join
- Patients with compound mutations in EGFR will be excluded from this study. Compound mutations are defined as 2 or more mutations in the EGFR tyrosine kinase domain with the following exceptions:
- C797S and EGFR exon 19 deletion or EGFR exon 21 point mutation and
- T790M mutation and EGFR exon 19 deletion or EGFR exon 21 point mutation.
- Prior therapy with temozolomide.
- Patients must not receive surgery or radiation as local therapies for the progressing CNS disease for which they are being enrolled on this trial. Ventriculoperitoneal shunt placement will be allowed for leptomeningeal disease with symptomatic hydrocephalis. Radiation or surgery for progressing extra-CNS disease is allowed.
- Patients with a history of an allergic/hypersensitivity reaction to any component of temozolomide, dacarbazine, osimertinib (for temozolomide plus osimertinib arm) or lorlatinib (for temozolomide plus lorlatinib arm).
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- Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.
- Patients with a history of baseline QTcF interval greater than 470 msec on electrocardiogram for the osimertinib plus temozolomide arm only.
- Unstable or clinically significant concurrent medical condition, psychiatric illness or social situation that would, in the opinion of the investigator, jeopardize the safety of a subject and/or their compliance with the protocol.
- Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy. Suppressive therapy for chronic infections allowed, for example:
- Subjects with HIV/AIDS with adequate antiviral therapy to control viral load would be allowed. Subjects with viral hepatitis with controlled viral load would be allowed while on suppressive antiviral therapy.
- Treated with any investigational drug or chemotherapy within 3 weeks or ≤ 5 half-lives of first dose of study treatment.
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.
- Patient is not taking any prohibited medications listed in section 6.4. (Strong CYP3A inducers should be stopped greater than 3 half-lives prior to starting study drugs for patients on either study drug combination. Moderate inducers of CYP3A should be stopped greater than 3 half-lives prior to starting study drugs for patients receiving lorlatinib plus temozolomide. Strong CYP3A inhibitors should be stopped greater than 3 half-lives prior to starting study drugs for patients receiving lorlatinib plus temozolomide.)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: A Phase 1 Study of Temozolomide in Combination With Targeted Therapy for NSCLC Patients With CNS Progression on Either Osimertinib or Lorlatinib
This trial is testing two novel combinations (temozolomide plus osimertinib OR temozolomide plus lorlatinib) which have not been evaluated in clinical trials. Thus, the exact benefits of these novel combinations are unclear. However, based on the mechanism of action of temozolomide and CNS(Central Nervous System) penetration/activity in other tumor types, it is hypothesized that adding temozolomide to osimertinib or temozolomide to lorlatinib may provide improvement in CNS disease control in patients with CNS progression on either of these latter two TKIs (Tyrosine kinase inhibitors).
- Conditions
- Non Small Cell Lung Cancer, CNS Progression
- Being tested
- Temozolomide plus Osimertinib, Temozolomide plus Lorlatinib
- 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.
Temozolomide plus OsimertinibDrug
Temozolomide is an oral alkylating chemotherapy which has good CNS penetration and has demonstrated CNS responses in both primary brain tumors (e.g., glioblastoma and anaplastic astrocytoma) and in small cell lung cancer (SCLC) brain metastases. Preclinical data from glioblastoma suggests potential synergy of concurrent ALK or EGFR inhibition with temozolomide and early phase trials in glioblastoma are ongoing investigating such combinations. It is felt that combining temozolomide with osimertinib or lorlatinib may be beneficial for patients with progressive CNS disease on either of these TKIs because of the high CNS penetration of temozolomide, good CNS activity of temozolomide in other tumor types and preclinical data from glioblastoma suggesting a potential enhanced effect of concurrent EGFR and ALK/ROS1 inhibition with temozolomide.
Temozolomide plus LorlatinibDrug
Temozolomide is an oral alkylating chemotherapy which has good CNS penetration and has demonstrated CNS responses in both primary brain tumors (e.g., glioblastoma and anaplastic astrocytoma) and in small cell lung cancer (SCLC) brain metastases. Preclinical data from glioblastoma suggests potential synergy of concurrent ALK or EGFR inhibition with temozolomide and early phase trials in glioblastoma are ongoing investigating such combinations. It is felt that combining temozolomide with osimertinib or lorlatinib may be beneficial for patients with progressive CNS disease on either of these TKIs because of the high CNS penetration of temozolomide, good CNS activity of temozolomide in other tumor types and preclinical data from glioblastoma suggesting a potential enhanced effect of concurrent EGFR and ALK/ROS1 inhibition with temozolomide
| Study group | Role | What they receive |
|---|---|---|
| Exon 19 deletions or L858R point mutations in exon 21 | Experimental | Will include patients with exon 19 deletions or L858R point mutations in exon 21 of the epidermal growth factor receptor (EGFR) gene. Temozolomide plus Osimertinib will be the study drug combination administered. Osimertinib will be given at a fixed dose of 80 mg daily for dose level 1, with a potential to increase to 160 mg daily for dose level 2. Temozolomide will be started at a dose of 150 mg/m2 on days 1-5 of a 28 day cycle for cycle 1 and if tolerated will be increased to 200 mg/m2 on days 1-5 of a 28 day cycle for cycles 2+. There will be a -1 dose level. Receives: Drug: Temozolomide plus Osimertinib |
| Patients with anaplastic lymphoma kinase (ALK) fusions | Experimental | Will include patients with anaplastic lymphoma kinase (ALK) fusions. Temozolomide plus Lorlatinib will be the study drug combination administered. Lorlatinib will be given at a fixed dose of 100 mg daily. Temozolomide will be started at a dose of 150 mg/m2 on days 1-5 of a 28 day cycle for cycle 1 and if tolerated will be increased to 200 mg/m2 on days 1-5 of a 28 day cycle for cycles 2+. There will be a -1 dose level depending on tolerability. Receives: Drug: Temozolomide plus Lorlatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Adverse events will be determined by the common terminology criteria for adverse events version 5.0
Measured: Up to 3.5 years
Secondary outcomes (8)
CNS response rate
Central Nervous System response rate according to the Response assessment in neuro-oncology (RANO) criteria per investigator assessment. Evaluable CNS lesions may not have been previously irradiated unless they are definitively progressing following radiation and prior to enrollment on the study.
Measured: Up to 3.5 years
Extra-CNS response rate
Extra-CNS response rate according to response evaluation criteria in solid tumors (RECIST) v1.1 per investigator assessment.
Measured: Up to 3.5 years
Overall response rate
Overall response rate including both RANO criteria for CNS response rate and RECIST v1.1 for extra-CNS response rate per investigator assessment.
Measured: Up to 3.5 years
Incidence of improvement in neurological function
Incidence of improvement in neurological function on two successive exams when compared to baseline as determined by one of two study neuro-oncologists
Measured: Up to 3.5 years
Progression free survival (PFS)
PFS will be defined as time from enrollment until development of CNS progressive disease according to the RANO criteria, development of extra-CNS disease progression according to RECIST v1.1 or death.
Measured: Up to 3.5 years
CNS PFS
CNS PFS will be defined as time from enrollment until development of CNS progressive disease per investigator assessment according to the RANO criteria or death.
Measured: Up to 3.5 years
Extra-CNS PFS
Extra-CNS PFS will be defined as time from enrollment until development of progressive disease outside the CNS per investigator assessment according RECIST v1.1 or death.
Measured: Up to 3.5 years
Overall Survival
OS will be defined as time from enrollment until death.Patients alive at date of end of study visit will be censored for survival.
Measured: Up to 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start29 Oct 2020
- Primary completion25 Apr 2022
- Study completion7 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase I, 3 + 3 dose escalation study of Temozolomide plus osimertinib, and temozolomide plus lorlatinib. The two drug combinations will each be examined separately in the 3 + 3 dose escalation schema to determine the MTD(Maximum tolerated dose) and RP2D(Recommended phase 2 dose).
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer League of Colorado
- Responsible party
- Sponsor
- Investigators
- Jose E Pacheco, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541407
- Sponsor's protocol ID
- 20-0138.cc
- Other IDs
- NCI-2020-13878
- Status last verified
- May 2023
- First submitted
- 1 Sep 2020
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Temozolomide in Combination With Targeted Therapy for NSCLC Patients With CNS Progression on Either Osimertinib or Lorlatinib
- ClinicalTrials.gov ID
- NCT04541407
- Acronym / sponsor ID
- 20-0138.cc
- Conditions
- Non Small Cell Lung Cancer, CNS Progression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Cancer League of Colorado
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 9 Sep 2020 (actual)
- 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.
This trial is testing two novel combinations (temozolomide plus osimertinib OR temozolomide plus lorlatinib) which have not been evaluated in clinical trials. Thus, the exact benefits of these novel combinations are unclear. However, based on the mechanism of action of temozolomide and CNS(Central Nervous System) penetration/activity in other tumor types, it is hypothesized that adding temozolomide to osimertinib or temozolomide to lorlatinib may provide improvement in CNS disease control in patients with CNS progression on either of these latter two TKIs (Tyrosine kinase inhibitors).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a phase I, 3 + 3 dose escalation study of Temozolomide plus osimertinib, and temozolomide plus lorlatinib. The two drug combinations will each be examined separately in the 3 + 3 dose escalation schema to determine the MTD(Maximum tolerated dose) and RP2D(Recommended phase 2 dose).
| Arm | Type | Receives |
|---|---|---|
| Exon 19 deletions or L858R point mutations in exon 21 | Experimental | Drug: Temozolomide plus OsimertinibWill include patients with exon 19 deletions or L858R point mutations in exon 21 of the epidermal growth factor receptor (EGFR) gene. Temozolomide plus Osimertinib will be the study drug combination administered. Osimertinib will be given at a fixed dose of 80 mg daily for dose level 1, with a potential to increase to 160 mg daily for dose level 2. Temozolomide will be started at a dose of 150 mg/m2 on days 1-5 of a 28 day cycle for cycle 1 and if tolerated will be increased to 200 mg/m2 on days 1-5 of a 28 day cycle for cycles 2+. There will be a -1 dose level. |
| Patients with anaplastic lymphoma kinase (ALK) fusions | Experimental | Drug: Temozolomide plus LorlatinibWill include patients with anaplastic lymphoma kinase (ALK) fusions. Temozolomide plus Lorlatinib will be the study drug combination administered. Lorlatinib will be given at a fixed dose of 100 mg daily. Temozolomide will be started at a dose of 150 mg/m2 on days 1-5 of a 28 day cycle for cycle 1 and if tolerated will be increased to 200 mg/m2 on days 1-5 of a 28 day cycle for cycles 2+. There will be a -1 dose level depending on tolerability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Male or female subject ≥ 18 years old
- ECOG performance status 0-2
- Stage IV NSCLC with progression of disease in the CNS on osimertinib 80 mg daily for patients with EGFR activating mutations (EGFR exon 19 deletions or EGFR L858R exon 21 point mutations) -OR- Stage IV NSCLC with progression of disease in the CNS on lorlatinib 100 mg daily for patients with ALK fusions
Key exclusion criteria (14 listed)
- Patients with compound mutations in EGFR will be excluded from this study. Compound mutations are defined as 2 or more mutations in the EGFR tyrosine kinase domain with the following exceptions:
- Prior therapy with temozolomide.
- Patients must not receive surgery or radiation as local therapies for the progressing CNS disease for which they are being enrolled on this trial. Ventriculoperitoneal shunt placement will be allowed for leptomeningeal disease with symptomatic hydrocephalis. Radiation or surgery for progressing extra-CNS disease is allowed.
- Patients with a history of an allergic/hypersensitivity reaction to any component of temozolomide, dacarbazine, osimertinib (for temozolomide plus osimertinib arm) or lorlatinib (for temozolomide plus lorlatinib arm).
- Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.
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 |
|---|---|---|
| Temozolomide plus OsimertinibTemozolomide is an oral alkylating chemotherapy which has good CNS penetration and has demonstrated CNS responses in both primary brain tumors (e.g., glioblastoma and anaplastic astrocytoma) and in small cell lung cancer (SCLC) brain metastases. Preclinical data from glioblastoma suggests potential synergy of concurrent ALK or EGFR inhibition with temozolomide and early phase trials in glioblastoma are ongoing investigating such combinations. It is felt that combining temozolomide with osimertinib or lorlatinib may be beneficial for patients with progressive CNS disease on either of these TKIs because of the high CNS penetration of temozolomide, good CNS activity of temozolomide in other tumor types and preclinical data from glioblastoma suggesting a potential enhanced effect of concurrent EGFR and ALK/ROS1 inhibition with temozolomide. | Drug | Exon 19 deletions or L858R point mutations in exon 21 |
| Temozolomide plus LorlatinibTemozolomide is an oral alkylating chemotherapy which has good CNS penetration and has demonstrated CNS responses in both primary brain tumors (e.g., glioblastoma and anaplastic astrocytoma) and in small cell lung cancer (SCLC) brain metastases. Preclinical data from glioblastoma suggests potential synergy of concurrent ALK or EGFR inhibition with temozolomide and early phase trials in glioblastoma are ongoing investigating such combinations. It is felt that combining temozolomide with osimertinib or lorlatinib may be beneficial for patients with progressive CNS disease on either of these TKIs because of the high CNS penetration of temozolomide, good CNS activity of temozolomide in other tumor types and preclinical data from glioblastoma suggesting a potential enhanced effect of concurrent EGFR and ALK/ROS1 inhibition with temozolomide | Drug | Patients with anaplastic lymphoma kinase (ALK) fusions |
Primary outcome
Adverse events
Time frame: Up to 3.5 years
Adverse events will be determined by the common terminology criteria for adverse events version 5.0
8 secondary outcomes
CNS response rate
Time frame: Up to 3.5 years
Extra-CNS response rate
Time frame: Up to 3.5 years
Overall response rate
Time frame: Up to 3.5 years
Incidence of improvement in neurological function
Time frame: Up to 3.5 years
Progression free survival (PFS)
Time frame: Up to 3.5 years
CNS PFS
Time frame: Up to 3.5 years
Extra-CNS PFS
Time frame: Up to 3.5 years
Overall Survival
Time frame: Up to 3.5 years
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 16 May 2023.
- 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.
Jose E Pacheco principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Temozolomide plus Osimertinib and Temozolomide plus Lorlatinib in people with Non Small Cell Lung Cancer and CNS Progression, run by University of Colorado, Denver 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 21 inclusion and 14 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 16 May 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 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.
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?
Adverse events (time frame: Up to 3.5 years). 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 16 May 2023.