Clinical trial · Interventional
G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| G1T38 | Drug | — | UNRESOLVED |
| Osimertinib | Drug | Osimertinib | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Part 1: Cohort 1 G1T38 + Osimertinib
- description
- 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).
- interventionNames
- Drug: G1T38
- Drug: Osimertinib
- type
- EXPERIMENTAL
- label
- Part 1: Cohort 2 G1T38 + Osimertinib
- description
- 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).
- interventionNames
- Drug: G1T38
- Drug: Osimertinib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available