PRESERVE 4
Research type
Research Study
Full title
A Phase 2 Randomized, Double-blind, Clinical Trial of Trilaciclib versus Placebo in Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) Treated with Docetaxel in the 2nd/3rd Line Setting (PRESERVE 4)
IRAS ID
1004021
Contact name
Melinda Bomar
Contact email
Sponsor organisation
G1 Therapeutics, Inc.
Eudract number
2021-000186-32
Clinicaltrials.gov Identifier
Research summary
Research Summary
Worldwide in 2018 there were more than 2 million cases of lung cancer, and 1.75 million lung cancer related deaths. Approximately 84% of these patients will be diagnosed with non-small cell lung cancer (NSCLC) and almost 70% will have locally advanced or metastatic (spreading) disease when they are diagnosed.
Historically, treatment of metastatic disease has involved the use of systemic chemotherapy (treatments that travel through the bloodstream). The development and addition of immunotherapy (treatment that stimulates the immune system) has significantly improved outcomes. Some patients receive immunotherapy followed by chemotherapy and some patients receive the two treatments together.
Despite improvements, the majority of patients ultimately worsening of their cancer during or after treatment with immunotherapy and chemotherapy. Second and third-line (second and third attempt) treatment is challenging and options are limited to single agent chemotherapies. These treatments often have limited impact on treatment outcomes and survival. Alternative therapies that extend overall survival without significant additive toxicity (sickness caused by treatment) are needed.
This clinical research study involves the use of trilaciclib for the treatment of NSCLC patients who require second/third-line treatment options. Trilaciclib is a CDK4/6 inhibitor that helps to protect the bone marrow and protect/activate the immune system during chemotherapy. The study aims to evaluate the effect of trilaciclib vs placebo on survival when added to chemotherapy. Approximately 60 sites in 8 countries will participate in this study, with the aim of recruiting approximately 146 patients. This study is sponsored by G1 Therapeutics, Inc.Summary of Results
Due to the changing landscape of treatments for patients with metastatic NSCLC treated with docetaxel in the 2nd/3rd line setting, the Sponsor announced the decision to terminate this study on 03 November 2021. This study was not terminated for any reasons related to safety.
A total of 7 patients were randomized into one of the two treatment groups in this study, and each patient received at least one dose of study drug (3 patients received placebo + chemotherapy and 4 patients received trilaciclib + chemotherapy). Once the study database was closed and locked (on 27-April 2022), there were no patients who continued to receive study drug or who remained ongoing in the study.
Due to the small number of patients randomized into the study, no efficacy data was evaluated. Safety evaluation of the 7 patients showed that all patients experienced at least 1 Adverse Event (AE), and all patients experienced at least 1 AE related to study drug. No patients had AEs that led to discontinuation of study drug. Adverse events were consistent with the expected safety profile of trilaciclib, and no new trilaciclib safety signals or concerns were identified.REC name
West of Scotland REC 1
REC reference
21/WS/0104
Date of REC Opinion
19 Oct 2021
REC opinion
Further Information Favourable Opinion