Carcinoma, Non-Small-Cell LungPhase 1/2NCT03455829
G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer
A Phase 1/2 study testing G1T38 and Osimertinib in people with Carcinoma, Non-Small-Cell Lung and Lung Cancer, run by G1 Therapeutics, Inc. at 8 sites in United States.
Trial summary
This was a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with osimertinib in patients with EGFR mutation-positive metastatic non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Lung Cancer, Non-small Cell Lung Cancer
- What is being tested?
- G1T38 and Osimertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 8 sitesUnited States
- Study dates
- 29 Mar 2018to 14 Feb 2022
- 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
- Confirmed EGFR mutation for non-small cell lung cancer associated with EGFR TKI sensitivity
- For Part 2, EGFR T790M mutation-positive tumor status
- Left ventricular ejection fraction (LVEF) ≥ institution's lower limit of the reference range
- For Part 1, evaluable or measurable disease as defined by RECIST, Version 1.1
- For Part 2, measurable disease as defined by RECIST, Version 1.1
- ECOG performance status 0 to 1
- Adequate organ function
Who cannot join
- Prior treatment with EGFR TKI within 9 days of first study dose
- For Part 1, prior treatment with more than 2 prior lines of chemotherapy for advanced NSCLC
- For Part 2, prior treatment with osimertinib or other T790M active EGFR TKI
- For Part 2, prior chemotherapy for advanced NSCLC
- Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
- Investigational drug within 3 months or 5 half-lives, whichever is longer, of first study dose
- Concurrent radiotherapy, radiotherapy within 28 days of first study dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to > 25% of bone marrow
- Prior hematopoietic stem cell or bone marrow transplantation
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Univ. of Michigan Hospitals
Ann Arbor, Michigan, 48109
Beverly Hills Cancer Center
Beverly Hills, California, 90211
Virginia Cancer Specialists
Fairfax, Virginia, 22301
Sylvester Comprehensive Cancer Center/University of Miami Miller School of Medicine Fox Building, Suite 200 G
Miami, Florida, 33136
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
UCLA Medical Center, Division of Hematology/Oncology/Clinical Research Unit
Santa Monica, California, 90404
St Joseph Heritage Healthcare
Santa Rosa, California, 95403
Mofitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: Phase 1b/2 Safety, Pharmacokinetic, and Efficacy Study of G1T38 in Combination With Osimertinib in Patients With EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)
This was a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with osimertinib in patients with EGFR mutation-positive metastatic non-small cell lung cancer.
The study was an open-label design, planned to consist of 2 parts: a safety, pharmacokinetic, and dose-finding portion (Part 1), and a randomized portion (Part 2). Both parts were to include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase began on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 144 patients were planned to be enrolled in the study.
Read the detailed description
Part 2, the Phase 2 part of the study, was not conducted due to changes in corporate strategy. There were no safety signals identified in Phase 1/Part 1 that would have precluded the conduct of Part 2. As a result, 30 out of the planned 144 patients were enrolled.
All tumor assessments were conducted by the Investigators or site radiologist. In order to reduce the burden to the patients, data of overall survival (OS) were no longer required (since 29 January 2020). No OS analysis was conducted for Part 1 due to limited data in Part 1.
PK data for Cohorts 4 (150 BID) and 5 (200 BID) were not analyzed as they were deemed unnecessary, as the PK data from Cohorts 1-3 were sufficient to achieve the secondary study objective of assessing the effect of osimertinib on PK parameters of G1T38.
- Being tested
- G1T38, Osimertinib
- Keywords
- Lung Cancer, Non-small Cell Lung Cancer, CDK 4/6 Inhibitor, EGFR-Positive, EGFR Mutation- Positive, T790M, EGFR Mutant, lerociclib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G1T38Drug
Also called Lerociclib
CDK 4/6 inhibitor
OsimertinibDrug
Also called Tagrisso
EGFR TKI; 80 mg
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cohort 1 G1T38 + Osimertinib | Experimental | Patients will receive a single oral dose of G1T38 on Cycle 1 Day -16 and on Cycle 1 Day -2. Patients will receive oral osimertinib 80 mg beginning Cycle 1 Days -14. Patients will begin G1T38 once-daily dosing on Cycle 1 Day 1 (in combination with osimertinib 80 mg). Receives: Drug: G1T38; Drug: Osimertinib |
| Part 1: Cohort 2 G1T38 + Osimertinib | Experimental | Patients will receive a single oral dose of G1T38 on Cycle 1 Day -16 and on Cycle 1 Day -2. Patients will receive oral osimertinib 80 mg beginning Cycle 1 Days -14. Patients will begin G1T38 once-daily dosing on Cycle 1 Day 1 (in combination with osimertinib 80 mg). Receives: Drug: G1T38; Drug: Osimertinib |
| Part 1: Cohort 3 G1T38 + Osimertinib | Experimental | Patients will receive a single oral dose of G1T38 on Cycle 1 Day -16 and on Cycle 1 Day -2. Patients will receive oral osimertinib 80 mg beginning Cycle 1 Days -14. Patients will begin G1T38 once-daily dosing on Cycle 1 Day 1 (in combination with osimertinib 80 mg). Receives: Drug: G1T38; Drug: Osimertinib |
| Part 1: Cohort 4 G1T38 + Osimertinib | Experimental | Patients will receive a single oral dose of G1T38 on Cycle 1 Day -16 and on Cycle 1 Day -2. Patients will receive oral osimertinib 80 mg beginning Cycle 1 Days -14. Patients will begin G1T38 once-daily dosing on Cycle 1 Day 1 (in combination with osimertinib 80 mg). Receives: Drug: G1T38; Drug: Osimertinib |
| Part 1: Cohort 5 G1T38 + Osimertinib | Experimental | Patients will receive a single oral dose of G1T38 on Cycle 1 Day -16 and on Cycle 1 Day -2. Patients will receive oral osimertinib 80 mg beginning Cycle 1 Days -14. Patients will begin G1T38 once-daily dosing on Cycle 1 Day 1 (in combination with osimertinib 80 mg). Receives: Drug: G1T38; Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
The percentage of patients experiencing DLTs in Part 1 of the study in each cohort, including:
- Grade 4 neutropenia
- ≥ Grade 3 neutropenic infection/febrile neutropenia
- Grade 4 thrombocytopenia
- ≥ Grade 3 thrombocytopenia with bleeding
- ≥ Grade 3 nonhematologic toxicity (additional criteria for nausea, vomiting, diarrhea, or fatigue: lasting > 5 days with maximal medical management)
- Liver function test abnormalities meeting Hy's Law criteria (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] ≥ 3 × upper limit of normal [ULN] and total bilirubin ≥ 2 × ULN).
Measured: Cycle 1 Day -16 to Cycle 1 Day 28
Secondary outcomes (6)
Progression Free Survival (PFS)
Median time (months) and 95% CI from date of first dose of study drug/randomization until date of documented disease progression or death due to any cause.
Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 guidelines for tumor assessments were used to determine progression. Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Measured: 36 months
Best Overall Tumor Response
The percentage of patients who fall into each category of Best overall response (BOR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 guidelines.
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
When no imaging/measurement is done, the patient is not evaluable (NE); and if only a subset of lesion measurements are made, usually the case is also considered NE.
Measured: 21 months
Pharmacokinetics of G1T38 and Metabolite G1T30: Maximum Plasma Concentration (Cmax)
The observed peak plasma concentration determined from the plasma concentration versus time data.
Measured: Part 1, Cycle 1 Day -16 to Day -2.
Pharmacokinetics of G1T38 and Metabolite G1T30: Area Under Curve - Plasma Concentration (AUC) Infinity
Area under the concentration-time curve from time zero extrapolated to infinity using the linear-up log-down trapezoidal rule.
Measured: Part 1, Cycle 1 Day -16 to Day -2.
Pharmacokinetics of G1T38 and Metabolite G1T30: Plasma: Terminal Half Life (T1/2)
Terminal half-life, defined as 0.693 divided by the terminal phase rate constant by λz , determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve.
Measured: Part 1, Cycle 1 Day -16 to Day -2.
Pharmacokinetics of G1T38: Plasma - Volume of Distribution
Volume of distribution in the terminal elimination phase, calculated as:
Vz/F = (CL/F)/λz
Measured: Part 1, Cycle 1 Day -16 to Day -2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start29 Mar 2018
- Primary completion14 Dec 2021
- Study completion14 Feb 2022
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 Carcinoma, Non-Small-Cell LungStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- G1 Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Contact, Study director, G1 Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455829
- Sponsor's protocol ID
- G1T38-03
- Other IDs
- 2017-004315-39, 2017
- Status last verified
- May 2023
- First submitted
- 28 Feb 2018
- Last updated
- 6 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b/2 Safety, Pharmacokinetic, and Efficacy Study of G1T38 in Combination With Osimertinib in Patients With EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT03455829
- Acronym / sponsor ID
- G1T38-03
- Keywords
- Lung Cancer, Non-small Cell Lung Cancer, CDK 4/6 Inhibitor, EGFR-Positive, EGFR Mutation- Positive, T790M, EGFR Mutant, lerociclib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- G1 Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Posted 1 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with osimertinib in patients with EGFR mutation-positive metastatic non-small cell lung cancer.
The study was an open-label design, planned to consist of 2 parts: a safety, pharmacokinetic, and dose-finding portion (Part 1), and a randomized portion (Part 2). Both parts were to include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase began on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 144 patients were planned to be enrolled in the study.
Detailed description
Part 2, the Phase 2 part of the study, was not conducted due to changes in corporate strategy. There were no safety signals identified in Phase 1/Part 1 that would have precluded the conduct of Part 2. As a result, 30 out of the planned 144 patients were enrolled.
All tumor assessments were conducted by the Investigators or site radiologist. In order to reduce the burden to the patients, data of overall survival (OS) were no longer required (since 29 January 2020). No OS analysis was conducted for Part 1 due to limited data in Part 1.
PK data for Cohorts 4 (150 BID) and 5 (200 BID) were not analyzed as they were deemed unnecessary, as the PK data from Cohorts 1-3 were sufficient to achieve the secondary study objective of assessing the effect of osimertinib on PK parameters of G1T38.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cohort 1 G1T38 + Osimertinib | Experimental | Drug: G1T38, Drug: OsimertinibPatients will receive a single oral dose of G1T38 on Cycle 1 Day -16 and on Cycle 1 Day -2. Patients will receive oral osimertinib 80 mg beginning Cycle 1 Days -14. Patients will begin G1T38 once-daily dosing on Cycle 1 Day 1 (in combination with osimertinib 80 mg). |
| Part 1: Cohort 2 G1T38 + Osimertinib | Experimental | Drug: G1T38, Drug: OsimertinibPatients will receive a single oral dose of G1T38 on Cycle 1 Day -16 and on Cycle 1 Day -2. Patients will receive oral osimertinib 80 mg beginning Cycle 1 Days -14. Patients will begin G1T38 once-daily dosing on Cycle 1 Day 1 (in combination with osimertinib 80 mg). |
| Part 1: Cohort 3 G1T38 + Osimertinib | Experimental | Drug: G1T38, Drug: OsimertinibPatients will receive a single oral dose of G1T38 on Cycle 1 Day -16 and on Cycle 1 Day -2. Patients will receive oral osimertinib 80 mg beginning Cycle 1 Days -14. Patients will begin G1T38 once-daily dosing on Cycle 1 Day 1 (in combination with osimertinib 80 mg). |
| Part 1: Cohort 4 G1T38 + Osimertinib | Experimental | Drug: G1T38, Drug: OsimertinibPatients will receive a single oral dose of G1T38 on Cycle 1 Day -16 and on Cycle 1 Day -2. Patients will receive oral osimertinib 80 mg beginning Cycle 1 Days -14. Patients will begin G1T38 once-daily dosing on Cycle 1 Day 1 (in combination with osimertinib 80 mg). |
| Part 1: Cohort 5 G1T38 + Osimertinib | Experimental | Drug: G1T38, Drug: OsimertinibPatients will receive a single oral dose of G1T38 on Cycle 1 Day -16 and on Cycle 1 Day -2. Patients will receive oral osimertinib 80 mg beginning Cycle 1 Days -14. Patients will begin G1T38 once-daily dosing on Cycle 1 Day 1 (in combination with osimertinib 80 mg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed EGFR mutation for non-small cell lung cancer associated with EGFR TKI sensitivity
- For Part 2, EGFR T790M mutation-positive tumor status
- Left ventricular ejection fraction (LVEF) ≥ institution's lower limit of the reference range
- For Part 1, evaluable or measurable disease as defined by RECIST, Version 1.1
- For Part 2, measurable disease as defined by RECIST, Version 1.1
Key exclusion criteria (8 listed)
- Prior treatment with EGFR TKI within 9 days of first study dose
- For Part 1, prior treatment with more than 2 prior lines of chemotherapy for advanced NSCLC
- For Part 2, prior treatment with osimertinib or other T790M active EGFR TKI
- For Part 2, prior chemotherapy for advanced NSCLC
- Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
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 |
|---|---|---|
| G1T38Also: LerociclibCDK 4/6 inhibitor | Drug | Part 1: Cohort 1 G1T38 + Osimertinib, Part 1: Cohort 2 G1T38 + Osimertinib, Part 1: Cohort 3 G1T38 + Osimertinib, Part 1: Cohort 4 G1T38 + Osimertinib, Part 1: Cohort 5 G1T38 + Osimertinib |
| OsimertinibAlso: TagrissoEGFR TKI; 80 mg | Drug | Part 1: Cohort 1 G1T38 + Osimertinib, Part 1: Cohort 2 G1T38 + Osimertinib, Part 1: Cohort 3 G1T38 + Osimertinib, Part 1: Cohort 4 G1T38 + Osimertinib, Part 1: Cohort 5 G1T38 + Osimertinib |
Primary outcome
Dose Limiting Toxicity
Time frame: Cycle 1 Day -16 to Cycle 1 Day 28
The percentage of patients experiencing DLTs in Part 1 of the study in each cohort, including: * Grade 4 neutropenia * ≥ Grade 3 neutropenic infection/febrile neutropenia * Grade 4 thrombocytopenia * ≥ Grade 3 thrombocytopenia with bleeding * ≥ Grade 3 nonhematologic toxicity (additional criteria for nausea, vomiting, diarrhea, or fatigue: lasting > 5 days with maximal medical management) * Liver function test abnormalities meeting Hy's Law criteria (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] ≥ 3 × upper limit of normal [ULN] and total bilirubin ≥ 2 × ULN).
6 secondary outcomes
Progression Free Survival (PFS)
Time frame: 36 months
Best Overall Tumor Response
Time frame: 21 months
Pharmacokinetics of G1T38 and Metabolite G1T30: Maximum Plasma Concentration (Cmax)
Time frame: Part 1, Cycle 1 Day -16 to Day -2.
Pharmacokinetics of G1T38 and Metabolite G1T30: Area Under Curve - Plasma Concentration (AUC) Infinity
Time frame: Part 1, Cycle 1 Day -16 to Day -2.
Pharmacokinetics of G1T38 and Metabolite G1T30: Plasma: Terminal Half Life (T1/2)
Time frame: Part 1, Cycle 1 Day -16 to Day -2.
Pharmacokinetics of G1T38: Plasma - Volume of Distribution
Time frame: Part 1, Cycle 1 Day -16 to Day -2.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Contact study director
G1 Therapeutics, Inc.
8 sites 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 G1T38 and Osimertinib in people with Carcinoma, Non-Small-Cell Lung and Lung Cancer, run by G1 Therapeutics, Inc. at 8 sites 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 7 inclusion and 8 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 6 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 8 sites 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 1 May 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?
Dose Limiting Toxicity (time frame: Cycle 1 Day -16 to Cycle 1 Day 28). 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 6 May 2023.