Phase 2
N=123
Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy
Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02514447 ↗Enrolled (actual)
123
Serious AEs
33.6%
Results posted
Jun 2022
Primary outcome: Primary: Duration of Severe (Grade 4) Neutropenia in Cycle 1 — 8; 1; 2; 14 days — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Trilaciclib (Drug); Placebo (Drug); Topotecan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- G1 Therapeutics, Inc.
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Severe (Grade 4) Neutropenia in Cycle 1 |
8; 1; 2; 14; 8; 0 | <0.0001 sig |
| PRIMARY Occurrence of Severe (Grade 4) Neutropenia |
22; 5; 13; 2; 2; 1 | 0.0160 sig |
| PRIMARY Assess the Dose Limiting Toxicities (DLTs) of G1T28/Trilaciclib Administered With Topotecan in Part 1 |
2; 2; 2; 0; 2; 2 | — |
| SECONDARY Pharmacokinetic Profile for Trilaciclib (G1T28) When Administered With Topotecan |
1060; 1220; 2220; 913; 1100 | — |
| SECONDARY Progression Free Survival (PFS) |
4.2; 3.0; 4.2; 5.5; 4.3; 3.6 | — |
| SECONDARY Overall Survival (OS) |
6.5; 5.8; 6.2; NA; 10.6; 8.3 | — |
| SECONDARY Assess the Hematologic Profile of G1T28/Trilaciclib Administered With Topotecan |
0.258; 0.091; 0.102; 0.403; 0.156; 0.102 | — |
| SECONDARY Tumor Response Based on RECIST, Version 1.1 |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Occurrence of RBC Transfusions |
12; 5; 10; 2; 1; 2 | — |
| SECONDARY Need for Treatment With Hematopoietic Growth Factors |
19; 8; 16; 2; 2; 1 | — |
| SECONDARY Chemotherapy Cycles and Modifications Overall |
4; 5; 5; 6; 7; 4 | — |
| SECONDARY Pharmacokinetic Profile for Topotecan When Administered With Trilaciclib (G1T28) |
21.1; 36.8; 52.4; NA; 43.0; 17.5 | — |
| SECONDARY Duration of Response (DOR) |
4.9; 7.8; 6.8; NA; 5.4; 6.7 | — |
| SECONDARY Occurrence of Intravenous (IV) Antibiotic Use |
8; 8; 7; 2; 1; 1 | — |
| SECONDARY Occurrence of Platelet Transfusions |
9; 4; 8; 0; 1; 0 | — |
| SECONDARY Occurrence of Febrile Neutropenia Adverse Events |
5; 1; 2; 0; 0; 0 | — |
| SECONDARY Occurrence of Infection Serious Adverse Events (SAEs) |
3; 2; 1; 2; 1; 1 | — |
| SECONDARY Occurrence of Pulmonary Infection Serious Adverse Events (SAEs) |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Dose Reductions in Chemotherapy (Topotecan) |
0.116; 0.053; 0.051; 0.500; 0.250; 0.118 | — |
| SECONDARY Occurrence of Grade 3 and 4 Hematologic Toxicities |
27; 25; 29; 2; 3; 4 | — |
| SECONDARY Occurrence of Grade 4 and Grade 3/4 Decreased Platelet Count Laboratory Values (Thrombocytopenia) |
19; 15; 21; 2; 2; 3 | — |
| SECONDARY Occurrence of Erythropoietin-stimulating Agent (ESA) Administrations |
6; 5; 1; 2; 1; 0 | — |
| SECONDARY Chemotherapy Exposure |
94; 110; 109; 147; 147; 102 | — |
Summary
This was a study to investigate the potential clinical benefit of trilaciclib (G1T28), a Cyclin Dependent Kinase (CDK) 4/6 inhibitor, in preserving the bone marrow and the immune system, in order to decrease chemotherapy-induced myelosuppression and improve anti-tumor efficacy when administered prior to topotecan in patients previously treated for extensive-stage SCLC.
The study consisted of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts included 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.
Eligibility Criteria
Key Inclusion Criteria
- Male or female subjects aged ≥18 years
- Confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry
- Progression during or after prior first- or second-line chemotherapy and eligible to receive topotecan therapy
- At least 1 target lesion that is measurable by RECIST, Version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- Adequate organ function
Key Exclusion Criteria
- Presence of brain metastases requiring immediate treatment with radiation therapy or steroids.
- Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure
- Known history of stroke or cerebrovascular accident within 6 months prior to enrollment
- Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
- Concurrent radiotherapy to any site or radiotherapy within 2 weeks prior to enrollment or previous radiotherapy to the target lesion sites
- Receipt of any systemic chemotherapy regimen within 4 weeks prior to enrollment or a noncytotoxic investigational medication within 2 weeks prior to enrollment
- History of topotecan treatment for SCLC
Data sourced from ClinicalTrials.gov (NCT02514447). 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.