Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Extensive Stage Small Cell Lung Cancer (SCLC)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03041311 |
|
Recruitment Status :
Active, not recruiting
First Posted : February 2, 2017
Last Update Posted : September 1, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing antitumor efficacy when administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line treatment for patients with newly diagnosed extensive-stage SCLC.
The study is a randomized, double-blinded, placebo-controlled design. The study will include 3 study phases: Screening Phase,Treatment Phase (induction part + maintenance part), and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 100 patients will be enrolled in the study.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Small Cell Lung Cancer | Drug: Trilaciclib Drug: Placebo Drug: Carboplatin Drug: Etoposide Drug: Atezolizumab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 105 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Phase 2 Study of Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib in Patients With Untreated Extensive Stage Small Cell Lung Cancer |
| Actual Study Start Date : | April 7, 2017 |
| Actual Primary Completion Date : | July 28, 2018 |
| Estimated Study Completion Date : | December 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: trilaciclib+etoposide/carboplatin/atezolizumab
Induction: Patients will receive trilaciclib 240 mg/m2 administered IV once daily on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m2 will be administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin will be administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 milligrams per milliliter per minute (mg/mL/min) to calculate the dose. Atezolizumab 1200 mg will be administered as an IV on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients will receive maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, withdrawal of consent, death, or study termination by the Sponsor. |
Drug: Trilaciclib
Trilaciclib IV
Other Name: G1T28 Drug: Carboplatin Carboplatin IV
Other Name: Paraplatin Drug: Etoposide Etoposide IV
Other Name: VP-16 Drug: Atezolizumab Atezolizumab IV
Other Name: Tecentriq |
|
Experimental: placebo+etoposide/carboplatin/atezolizumab
Induction: Patients will receive placebo administered IV once daily on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m2 will be administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin will be administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 milligrams per milliliter per minute (mg/mL/min) to calculate the dose. Atezolizumab 1200 mg will be administered as an IV on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients will receive maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, withdrawal of consent, death, or study termination by the Sponsor. |
Drug: Placebo
Placebo IV Drug: Carboplatin Carboplatin IV
Other Name: Paraplatin Drug: Etoposide Etoposide IV
Other Name: VP-16 Drug: Atezolizumab Atezolizumab IV
Other Name: Tecentriq |
- Evaluate the potential of trilaciclib to reduce chemotherapy-induced myelosuppression [ Time Frame: 12 Months ]
- Overall survival (OS) [ Time Frame: 36 months ]
- PFS based on RECIST v1.1 [ Time Frame: 36 Months ]
- Number of patients with objective response (CR or PR) based on RECIST v1.1 [ Time Frame: 36 Months ]
- Treatment related adverse events (AE) based on NCI CTCAE v4.0 [ Time Frame: 24 months ]
- Abnormal Laboratory Events [ Time Frame: 24 Months ]
- Incidence of of immune-related adverse events (irAEs) [ Time Frame: 24 Months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female subjects aged ≥18 years
- Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry
- 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
Exclusion Criteria:
- Prior chemotherapy for extensive-stage SCLC
- Prior immunotherapies including but not limited to CD137, anti-PD-1, anti-PD-L1, and CTLA4.
- Presence of symptomatic brain metastases requiring immediate treatment with radiation therapy or steroids.
- History of pulmonary fibrosis, organizing pneumonia or pneumonitis on screening chest CT
- Active, known, suspected autoimmune disease requiring systemic treatment in the past 2 years
- 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
- Receipt of any investigational medication within 4 weeks prior to enrollment
- Administration of attenuated vaccine within 4 weeks before enrollment
- Systemic treatment with corticosteriods or other immunosuppressive medications within 14 days of study drug administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041311
Show 44 study locations
| Study Director: | Clinical Contact | G1 Therapeutics, Inc. |
| Responsible Party: | G1 Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT03041311 |
| Other Study ID Numbers: |
G1T28-05 2017-000358-20 ( EudraCT Number ) |
| First Posted: | February 2, 2017 Key Record Dates |
| Last Update Posted: | September 1, 2020 |
| Last Verified: | July 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Small Cell Lung Cancer CDK 4/6 Inhibitor Immune Checkpoint Inhibitor |
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Carboplatin Etoposide Atezolizumab Antineoplastic Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |