Phase 2
Completed N=30
G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT03455829 ↗Enrolled (actual)
30
Serious AEs
20.0%
Results posted
May 2023
Primary outcomePrimary: Dose Limiting Toxicity — 0; 0; 1; 0 Participants
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.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Limiting Toxicity |
0; 0; 1; 0; 0 | — |
| SECONDARY Progression Free Survival (PFS) |
19.3; 6.0; 1.4; 7.2; 12.9 | — |
| SECONDARY Best Overall Tumor Response |
0; 0; 0; 0; 0; 2 | — |
| SECONDARY Pharmacokinetics of G1T38 and Metabolite G1T30: Maximum Plasma Concentration (Cmax) |
27.229; 33.375; 43.850; 17.257; 26.400; 42.700 | — |
| SECONDARY Pharmacokinetics of G1T38 and Metabolite G1T30: Area Under Curve - Plasma Concentration (AUC) Infinity |
319.6; 391.0; 715.6; 277.4; 390.0; 802.3 | — |
| SECONDARY Pharmacokinetics of G1T38 and Metabolite G1T30: Plasma: Terminal Half Life (T1/2) |
13.83; 16.30; 15.59; 13.59; 12.61; 13.93 | — |
| SECONDARY Pharmacokinetics of G1T38: Plasma - Volume of Distribution |
14000; 18700; 15900; 14900; 14800; 12900 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03455829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.