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CDK 4/6 Inhibitor

G1T38 for Non-Small Cell Lung Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by G1 Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial is investigating whether a new drug, G1T38, is safe and effective when combined with osimertinib for patients with EGFR mutation-positive metastatic non-small cell lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity
Secondary outcome measures
Best Overall Tumor Response
Pharmacokinetics of G1T38 and Metabolite G1T30: Area Under Curve - Plasma Concentration (AUC) Infinity
Pharmacokinetics of G1T38 and Metabolite G1T30: Maximum Plasma Concentration (Cmax)
+3 more

Side effects data

From 2022 Phase 1 & 2 trial • 30 Patients • NCT03455829
71%
Anaemia
71%
Vomiting
71%
Neutrophil count decreased
71%
Diarrhoea
71%
Nausea
71%
Headache
57%
Hyperglycaemia
57%
Leukopenia
57%
Neutropenia
57%
Transaminases increased
43%
Insomnia
43%
Muscle spasms
43%
Decreased appetite
43%
Conjunctivitis
43%
Lymphopenia
43%
Thrombocytopenia
43%
Abdominal pain
43%
Lymphocyte count decreased
43%
Hyponatraemia
43%
Dyspnoea
43%
Dysgeusia
43%
Rash
29%
Dry mouth
29%
Dysuria
29%
Stomatitis
29%
Blood lactate dehydrogenase increased
29%
Chills
29%
Urinary tract infection
29%
Fatigue
29%
Constipation
29%
Blood alkaline phosphatase increased
29%
Cough
29%
Mucosal inflammation
29%
Dizziness
29%
Neck pain
29%
Musculoskeletal pain
29%
Vision blurred
29%
Myalgia
29%
Dry skin
29%
Proteinuria
29%
Visual impairment
29%
Hypertension
29%
Back pain
14%
Abdominal discomfort
14%
Abdominal pain upper
14%
Hyperkalaemia
14%
Hyperphosphataemia
14%
Viral infection
14%
Pruritus
14%
Glycosuria
14%
COVID-19 pneumonia
14%
Upper respiratory tract infection
14%
Secretion discharge
14%
Chest pain
14%
Skin infection
14%
Pharyngitis
14%
Pulmonary embolism
14%
Gastrooesophageal reflux disease
14%
Alanine aminotransferase increased
14%
Blood creatinine increased
14%
Hypocalcaemia
14%
Dyspnoea exertional
14%
Nasal congestion
14%
Pyuria
14%
Haemoptysis
14%
Nasal dryness
14%
Oropharyngeal pain
14%
Pleuritic pain
14%
Malaise
14%
Arthralgia
14%
Night sweats
14%
Dermatitis
14%
Haematuria
14%
Eye pain
14%
Deep vein thrombosis
14%
Proctalgia
14%
Hypophosphataemia
14%
Paranasal sinus discomfort
14%
Early satiety
14%
Xeroderma
14%
Micturition urgency
14%
Conjunctival haemorrhage
14%
Fall
14%
Tachycardia
14%
Ear pain
14%
Hepatic steatosis
14%
Toothache
14%
White blood cell count decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Cohort 1 Lerociclib at 200 mg QD
Part 1: Cohort 2 Lerociclib at 300 mg QD
Part 1: Cohort 3 Lerociclib at 400 mg QD
Part 1: Cohort 4 Lerociclib at 150 mg BID
Part 1: Cohort 5 Lerociclib at 200 mg BID

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part 1: Cohort 5 G1T38 + OsimertinibExperimental Treatment2 Interventions
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).
Group II: Part 1: Cohort 4 G1T38 + OsimertinibExperimental Treatment2 Interventions
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).
Group III: Part 1: Cohort 3 G1T38 + OsimertinibExperimental Treatment2 Interventions
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).
Group IV: Part 1: Cohort 2 G1T38 + OsimertinibExperimental Treatment2 Interventions
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).
Group V: Part 1: Cohort 1 G1T38 + OsimertinibExperimental Treatment2 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
G1T38
2018
Completed Phase 2
~30
Osimertinib
2017
Completed Phase 4
~1010

Find a Location

Who is running the clinical trial?

G1 Therapeutics, Inc.Lead Sponsor
21 Previous Clinical Trials
3,261 Total Patients Enrolled
Clinical ContactStudy DirectorG1 Therapeutics, Inc.
10 Previous Clinical Trials
1,285 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer
2018. "G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03455829.
~4 spots leftby Apr 2025
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