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| Name | Class |
|---|---|
| G1 Therapeutics, Inc. | INDUSTRY |
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A Randomized, double-blind, placebo-controlled, multi-center Phase 3 study evaluating efficacy, safety and pharmacokinetics of Trilaciclib In Extensive-Stage Small Cell Lung Cancer Patients Receiving Carboplatin combined with Etoposide or Topotecan The study consists of 2 parts: Part 1: safety run-in and pharmacokinetics evaluation of 12 ES-SCLC patients (6 each for first line and second/third line ES-SCLC patients); Part 2: randomized, double-blind, placebo-controlled efficacy confirmation study of 80 ES-SCLC patients (stratified by first line and second/third line ES-SCLC, ECOG PS [0-1 vs 2] and brain metastases.
The study includes screening period, treatment period, safety follow-up and survival follow-up.
This is a multi-center Phase 3 clinical trial with an open-label single-arm safety run-in and PK evaluation part and a randomized double-blind, placebo controlled part in patients with ES-SCLC to evaluate the safety, efficacy, and pharmacokinetic profile of Trilaciclib based on completed clinical studies abroad.
The study consists of 2 parts. The first part, safety run-in and PK evaluation, enrolled approximately 12 patients with extensive-stage small-cell lung cancer, 6 patients each with 1st line ES-SCLC and 2nd/3rd line ES-SCLC to receive Trilaciclib in combination with carboplatin and etoposide (EC regimen) or with topotecan, and based on evaluable data from Cycle 1, evaluated the safety, tolerability, pharmacokinetics, and preliminary efficacy (prevention of myelosuppression) of Trilaciclib. The second part is a randomized double-blind, placebo-controlled efficacy validation study, and approximately 80 patients with ES-SCLC will be enrolled in Part II, stratified by 1st line vs 2nd/3rd line ES-SCLC, ECOG PS (0-1 vs 2), and presence vs absence of brain metastases, and randomized in a 1:1 ratio to Trilaciclib and placebo, in which patients with 1st line ES-SCLC receive Trilaciclib/placebo combined with EC regimen (Trilaciclib-EC group and placebo-EC group), and patients with 2nd/3rd line ES-SCLC receive Trilaciclib/placebo combined with topotecan (Trilaciclib-TPT group and placeboTPT group), and the efficacy of Trilaciclib (prevention of myelosuppression) will be evaluated with duration of severe neutropenia (DSN) in Cycle 1 as the primary endpoint. The planned dose of Trilaciclib is 240 mg/m2. If the safety data from the first part of the study suggest that the dose of Trilaciclib needs to be adjusted, 12 additional patients (6 patients each for 1st line ES-SCLC and 2nd/3rd line ESSCLC) will be enrolled in the first part of the study to explore the PK and safety of Trilaciclib 200 mg/m2. The study process includes screening period, treatment period, safety followup and survival follow-up.
The end of the study was defined as death in 75% of subjects, or 12 months after the last subject was enrolled, or the sponsor decided to terminate the study, whichever came first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I ( Safety run-in and PK Evaluation); Trilaciclib Group | Active Comparator | 12 patients( 6 patients are first line, 6 patients are second or third line) recieved Trilaciclib(240mg/m^2) plus chemotherapy. |
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| Part II ( Randomized Double-blind, Placebo-controlled ), Trilaciclib Group | Active Comparator | 41 patients received trilaciclib(240mg/m^2) plus chemotherapy |
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| Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | Placebo Comparator | 42 patients received placebo plus chemotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trilaciclib, carboplatin, etoposide，or Topotecan | Drug | Trilaciclib plus carboplatin, etoposide for first line patients ;Trilaciclib plus Topotecan for second or third line patients |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinity(AUC0-inf) for Part 1 | AUC0-inf of trilaciclib in plasma was determined from individual concentration-time data by non-compartmental analysis methods. The actual sampling times in relation to dosing were used. | Day1 and Day 3( or Day 5) of Cycle 1 for a 21-day cycle |
| Duration of Severe Neutropenia in Cycle 1 (DSN) | DSN in Cycle 1 was defined as the number of days from the date of the first ANC value < 0.5 x 10^9/L in Cycle 1 to the date of the first ANC value ≥ 0.5 x 10^9/L. The date of the first ANC value ≥ 0.5 x 10^9/L should meet the following requirements: (1) occurred after the ANC value was < 0.5 x 10^9/L, and (2) there were no other ANC values < 0.5 x 10^9/L between this date and the end of Cycle 1 (otherwise, if this patient entered Cycle 2, it was counted as Day 1 of Cycle 2). DSN in Cycle 1 was scored as 0 if the patient did not experience any SN during Cycle 1. | At the end of Cycle 1 (each cycle is 21 days) |
| Maximum Observed Plasma Concentration(Cmax) of Trilaciclib for Part 1 | Cmax of trilaciclib in plasma was determined from individual concentration-time data by non-compartmental analysis methods. The actual sampling times in relation to dosing were used. For estimation of Cmax, a concentration that was below the limit of quantification (BLQ) was assigned a value of zero if it occurred in a profile before the first measurable concentration. If a BLQ value occurred after a measurable concentration in a profile, and was followed by a value above the lower limit of quantification, then the BLQ was treated as missing data. If a BLQ value occurred at the end of the collection interval (after the last quantifiable concentration) it was treated as missing data. If two BLQ values occurred in succession after Cmax, the profile was deemed to have terminated at the first BLQ value and any subsequent concentrations were omitted. | Day1 and Day 3( or Day 5) of Cycle 1 for a 21-day cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Severe Neutropenia (SN) | Severe (Grade 4) neutropenia was defined as at least 1 ANC value <0.5 × 10^9/L during the treatment period. | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
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Inclusion Criteria:
Age ≥ 18 years, male or female;
Histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC):
Presence of at least one radiation-naïve measurable lesion according to RECIST 1.1 criteria;
Hemoglobin ≥ 90 g/L;
Neutrophil count ≥ 1.5 × 10^9/L;
Platelet count ≥ 100 × 10^9/L;
Creatinine ≤ 15 mg/L or creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula);
Total bilirubin ≤ 1.5 × upper limit of normal (ULN);
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN or ≤ 5 × ULN (for patients with liver metastases);
Albumin ≥ 30 g/L;
ECOG PS score 0 - 2;
Expected survival time ≥ 3 months;
Contraception:
Females: All females of childbearing potential must have a negative serum pregnancy test at screening and must use reliable contraception from signing of informed consent through 3 months after the last dose; Male: Female partners of childbearing potential must use reliable contraception from signing the informed consent until 3 months after the last dose;
Understand and sign informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying Cheng, Doctor | Jilin Provincial Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jilin Cancer Hopspital | Changchun | China |
For Part 1, of 14 enrolled participants, 12 met inclusion criteria and were treated with trilaicilib plus chemotherapy. For Part 2, of 105 enrolled participants, 83 met inclusion criteria and were randomized to treatment.
For Part 1, participants were recruited based on physician referral at 4 academic medical centers ，and the first participant was enrolled on May 25, 2021 and the last participant was enrolled in July 20 2021. For Part 2, participants were recruited based on physician referral at 20 academic medical centers ，and the first participant was enrolled in August 20, 2021 and the last participant was enrolled in December 1 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part I ( Safety run-in and PK Evaluation); Trilaciclib Group | 12 patients( 6 patients are first line, 6 patients are second or third line) recieved Trilaciclib(240mg/m^2) plus chemotherapy. Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. Carboplatin - administered on Day 1 of each 21-day cycle at a target AUC of 5 (maximum dose 750 mg calculated according to Calvert formula) over 30 min by intravenous infusion; etoposide - administered on Days 1, 2, and 3 of each 21-day cycle at 100 mg/m^2 over 60 min by intravenous infusion; topotecan - administered on Days 1-5 of each 21-day cycle at 1.25 mg/m^2 over 30 min by intravenous infusion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 21, 2022 | Apr 17, 2024 |
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| placebo, carboplatin, etoposide，or Topotecan | Drug | placebo plus carboplatin, etoposide for first line patients ;placebo plus Topotecan for second or third line patients |
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| Occurrence of Red Blood Cell Transfusion (on/After Week 5) | The occurrence of RBC transfusions was defined as at least 1 cycle with RBC transfusion during the treatment period. For the treatment period, the total number of RBC transfusions was the number of cycles with RBC transfusions. | From week 5 to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
| Granulocyte Colony Stimulating Factor (G-CSF) Use Rate | Administration of G-CSF was collected with concomitant medications, which were coded using World Health Organization Drug Dictionary (WHO-DD) . A cycle where G-CSF was administered concurrently was identified by comparing the start and stop dates of each administration of G-CSF to the start of cycle and end of cycle. The occurrence of G-CSF administrations was defined as at least 1 cycle with G-CSF administrations during the treatment period. For the treatment period, the total number of G-CSF administrations was the number of cycles with G-CSF administrations. | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
| Composite Endpoints-major Hematologic AEs (Anyone of the Followings): All-cause Hospitalization; All-cause Dose Reductions; Febrile Neutropenia; SN Prolongation (Lasting > 5 Days); Red Blood Cell (RBC) Transfusions Were Performed on/After Week 5. | MAHE was a composite endpoint incorporating the measurement of several clinically meaningful aspects of myelopreservation into a single endpoint. The individual components for MAHE were hospitalization for a hematologic event, febrile neutropenia, death related to treatment, dose delay/reduction due to ANC or platelet counts, prolonged severe neutropenia (duration >5 days), RBC transfusion (actual or eligible) and platelet transfusion (actual or eligible). Event rate per week， calculated as the total number of events divided by duration of in weeks. | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
| Occurrence of Grade 3 and 4 Hematological Toxicities | Occurrence of Grade 3 and 4 hematological toxicities was defined according to CTCAE 5.0 during the treatment period. | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
| Erythropoiesis Stimulating Agent (ESA) Use Rate | Administration of ESA was collected with concomitant medications, which were coded using WHO-DD . A cycle where an ESA was administered concurrently was identified by comparing the start and stop dates of each administration of an ESA to the start of cycle and end of cycle. The occurrence of ESA administration was at least 1 cycle with an ESA administration during the treatment period. For the treatment period, the total number of ESA administrations was the number of cycles with ESA administrations. | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
| Recombinant Human Interleukin-11 Use Rate | Administration of interleukin-11 was collected with concomitant medications, which were coded using WHO-DD Version. A cycle where interleukin-11 was administered concurrently was identified by comparing the start and stop dates of each administration of interleukin-11 to the start of cycle and end of cycle. The occurrence of interleukin-11 administration was at least 1 cycle with interleukin-11 administration during the treatment period. | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
| Thrombopoietin (TPO) Use Rate | Administration of TPO was collected with concomitant medications, which were coded using WHO-DD Version. A cycle where TPO was administered concurrently was identified by comparing the start and stop dates of each administration of TPO to the start of cycle and end of cycle. The occurrence of TPO administration was at least 1 cycle with TPO administration during the treatment period. | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
| Occurrence of Intravenous or Oral Antibiotic Administration | Administration of intravenous or oral antibiotic was collected with concomitant medications, which were coded using WHO-DD Version. A cycle where intravenous or oral antibiotic was administered concurrently was identified by comparing the start and stop dates of each administration of intravenous or oral antibiotic to the start of cycle and end of cycle. The occurrence of intravenous or oral antibiotic administration was at least 1 cycle with intravenous or oral antibiotic administration during the treatment period. | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
| Occurrence of Infectious Serious Adverse Events | SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect. An infectious SAE was a serious event in the Medical Dictionary for Regulatory Activities (MedDRA) system organ class "infections and infestations" and a preferred term of anal abscess, bacteraemia, bronchitis, candida infection, chronic sinusitis, conjunctivitis, infection, influenza, nasopharyngitis, oral candidiasis, oral herpes, pharyngitis streptococcal, pneumonia, pneumonia bacterial, respiratory tract infection, sepsis, skin infection, upper respiratory tract infection, urinary tract infection, urosepsis or viral upper respiratory tract infection. | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
| Occurrence of Lung Infection SAEs | SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect. A lung infection SAE was a serious event in the MedDRA system organ class "infections and infestations" and a preferred term of bronchitis, influenza, pneumonia, pneumonia bacterial, respiratory tract infection, upper respiratory tract infection or viral upper respiratory tract infection. | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
| Occurrence of Febrile Neutropenia | Each febrile neutropenia event (as defined by Common Terminology Criteria for Adverse Events [CTCAE]) was captured as an AE. The occurrence of febrile neutropenia was defined as at least 1 febrile neutropenia event during the treatment period. For the treatment period, the total number of febrile neutropenia events was the number of febrile neutropenia events with a unique start date. | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
| Occurrence of Platelet Transfusion | The occurrence of platelet transfusions was defined as at least 1 cycle with platelet transfusion during the treatment period. For the treatment period, the total number of platelet transfusions was the number of cycles with platelet transfusions. | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
| Objective Tumor Response Rate (ORR) | ORR was performed based on the Response Evaluation Analysis Set (RES). Based on the assessments at each visit, the number and percentage of patients with best response of CR, PR, SD, PD and NE will be summarized by treatment group when CR/PR confirmation is not required and CR/PR confirmation is required, respectively . In particular, SD BOR requires at least 35 days or more after enrollment.ORR was calculated based on the number of patients with best response of CR or PR. | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 18 months |
| Disease Control Rate (DCR) | DCR was performed based on the Response Evaluation Analysis Set (RES). Based on the assessments at each visit, the number and percentage of patients with best response of CR, PR, SD, PD and NE will be summarized by treatment group when CR/PR confirmation is not required and CR/PR confirmation is required, respectively . In particular, SD BOR requires at least 35 days or more after enrollment. DCR was calculated based on the number of patients with best response of CR PR or SD. | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 18 months |
| FG001 | Part II ( Randomized Double-blind, Placebo-controlled ), Trilaciclib Group | 41 patients received trilaciclib(240mg/m^2) plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. Carboplatin - administered on Day 1 of each 21-day cycle at a target AUC of 5 (maximum dose 750 mg calculated according to Calvert formula) over 30 min by intravenous infusion; etoposide - administered on Days 1, 2, and 3 of each 21-day cycle at 100 mg/m^2 over 60 min by intravenous infusion; topotecan - administered on Days 1-5 of each 21-day cycle at 1.25 mg/m^2 over 30 min by intravenous infusion. |
| FG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. Carboplatin - administered on Day 1 of each 21-day cycle at a target AUC of 5 (maximum dose 750 mg calculated according to Calvert formula) over 30 min by intravenous infusion; etoposide - administered on Days 1, 2, and 3 of each 21-day cycle at 100 mg/m^2 over 60 min by intravenous infusion; topotecan - administered on Days 1-5 of each 21-day cycle at 1.25 mg/m^2 over 30 min by intravenous infusion. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part I ( Safety run-in and PK Evaluation); Trilaciclib Group | 12 patients( 6 patients are first line, 6 patients are second or third line) recieved Trilaciclib(240mg/m^2) plus chemotherapy. Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
| BG001 | Part II ( Randomized Double-blind, Placebo-controlled ), Trilaciclib Group | 41 patients received trilaciclib(240mg/m^2) plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
| BG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Brain metastases at baseline | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | Area Under the Plasma Concentration Versus Time Curve From Time Zero Extrapolated to Infinity(AUC0-inf) for Part 1 | AUC0-inf of trilaciclib in plasma was determined from individual concentration-time data by non-compartmental analysis methods. The actual sampling times in relation to dosing were used. | PK Analysis Set (PKS): All patients who received at least one dose of the study drug and had at least one valid concentration data of the tested components after drug administration. Pharmacokinetic analyses will be based on the PKS set. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Day1 and Day 3( or Day 5) of Cycle 1 for a 21-day cycle |
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| Primary | Duration of Severe Neutropenia in Cycle 1 (DSN) | DSN in Cycle 1 was defined as the number of days from the date of the first ANC value < 0.5 x 10^9/L in Cycle 1 to the date of the first ANC value ≥ 0.5 x 10^9/L. The date of the first ANC value ≥ 0.5 x 10^9/L should meet the following requirements: (1) occurred after the ANC value was < 0.5 x 10^9/L, and (2) there were no other ANC values < 0.5 x 10^9/L between this date and the end of Cycle 1 (otherwise, if this patient entered Cycle 2, it was counted as Day 1 of Cycle 2). DSN in Cycle 1 was scored as 0 if the patient did not experience any SN during Cycle 1. | The FAS included all enrolled patients who received at least one dose of study drug according to the intention-to-treat (ITT) principle. | Posted | Mean | Standard Deviation | Days | At the end of Cycle 1 (each cycle is 21 days) |
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| Primary | Maximum Observed Plasma Concentration(Cmax) of Trilaciclib for Part 1 | Cmax of trilaciclib in plasma was determined from individual concentration-time data by non-compartmental analysis methods. The actual sampling times in relation to dosing were used. For estimation of Cmax, a concentration that was below the limit of quantification (BLQ) was assigned a value of zero if it occurred in a profile before the first measurable concentration. If a BLQ value occurred after a measurable concentration in a profile, and was followed by a value above the lower limit of quantification, then the BLQ was treated as missing data. If a BLQ value occurred at the end of the collection interval (after the last quantifiable concentration) it was treated as missing data. If two BLQ values occurred in succession after Cmax, the profile was deemed to have terminated at the first BLQ value and any subsequent concentrations were omitted. | PK Analysis Set (PKS): All patients who received at least one dose of the study drug and had at least one valid concentration data of the tested components after drug administration. Pharmacokinetic analyses will be based on the PKS set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day1 and Day 3( or Day 5) of Cycle 1 for a 21-day cycle |
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| Secondary | Occurrence of Severe Neutropenia (SN) | Severe (Grade 4) neutropenia was defined as at least 1 ANC value <0.5 × 10^9/L during the treatment period. | The FAS included all enrolled patients who received at least one dose of study drug according to the intention-to-treat (ITT) principle. | Posted | Count of Participants | Participants | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
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| Secondary | Occurrence of Red Blood Cell Transfusion (on/After Week 5) | The occurrence of RBC transfusions was defined as at least 1 cycle with RBC transfusion during the treatment period. For the treatment period, the total number of RBC transfusions was the number of cycles with RBC transfusions. | The FAS included all randomized patients who received at least one dose of study drug according to the intention-to-treat (ITT) principle. | Posted | Count of Participants | Participants | From week 5 to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
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| Secondary | Granulocyte Colony Stimulating Factor (G-CSF) Use Rate | Administration of G-CSF was collected with concomitant medications, which were coded using World Health Organization Drug Dictionary (WHO-DD) . A cycle where G-CSF was administered concurrently was identified by comparing the start and stop dates of each administration of G-CSF to the start of cycle and end of cycle. The occurrence of G-CSF administrations was defined as at least 1 cycle with G-CSF administrations during the treatment period. For the treatment period, the total number of G-CSF administrations was the number of cycles with G-CSF administrations. | The FAS included all randomized patients who received at least 1 dose of study drug according to the intention-to-treat (ITT) principle. | Posted | Count of Participants | Participants | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
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| Secondary | Composite Endpoints-major Hematologic AEs (Anyone of the Followings): All-cause Hospitalization; All-cause Dose Reductions; Febrile Neutropenia; SN Prolongation (Lasting > 5 Days); Red Blood Cell (RBC) Transfusions Were Performed on/After Week 5. | MAHE was a composite endpoint incorporating the measurement of several clinically meaningful aspects of myelopreservation into a single endpoint. The individual components for MAHE were hospitalization for a hematologic event, febrile neutropenia, death related to treatment, dose delay/reduction due to ANC or platelet counts, prolonged severe neutropenia (duration >5 days), RBC transfusion (actual or eligible) and platelet transfusion (actual or eligible). Event rate per week， calculated as the total number of events divided by duration of in weeks. | The FAS included all randomized patients who received at least 1 dose of study drug according to the intention-to-treat (ITT) principle. | Posted | Number | events per week | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
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| Secondary | Occurrence of Grade 3 and 4 Hematological Toxicities | Occurrence of Grade 3 and 4 hematological toxicities was defined according to CTCAE 5.0 during the treatment period. | The FAS included all randomized patients who received at least 1 dose of study drug according to the intention-to-treat (ITT) principle. | Posted | Count of Participants | Participants | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
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| Secondary | Erythropoiesis Stimulating Agent (ESA) Use Rate | Administration of ESA was collected with concomitant medications, which were coded using WHO-DD . A cycle where an ESA was administered concurrently was identified by comparing the start and stop dates of each administration of an ESA to the start of cycle and end of cycle. The occurrence of ESA administration was at least 1 cycle with an ESA administration during the treatment period. For the treatment period, the total number of ESA administrations was the number of cycles with ESA administrations. | The FAS included all randomized patients who received at least 1 dose of study drug according to the intention-to-treat (ITT) principle. | Posted | Count of Participants | Participants | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
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| Secondary | Recombinant Human Interleukin-11 Use Rate | Administration of interleukin-11 was collected with concomitant medications, which were coded using WHO-DD Version. A cycle where interleukin-11 was administered concurrently was identified by comparing the start and stop dates of each administration of interleukin-11 to the start of cycle and end of cycle. The occurrence of interleukin-11 administration was at least 1 cycle with interleukin-11 administration during the treatment period. | The FAS included all randomized patients who received at least 1 dose of study drug according to the intention-to-treat (ITT) principle. | Posted | Count of Participants | Participants | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
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| Secondary | Thrombopoietin (TPO) Use Rate | Administration of TPO was collected with concomitant medications, which were coded using WHO-DD Version. A cycle where TPO was administered concurrently was identified by comparing the start and stop dates of each administration of TPO to the start of cycle and end of cycle. The occurrence of TPO administration was at least 1 cycle with TPO administration during the treatment period. | The FAS included all randomized patients who received at least 1 dose of study drug according to the intention-to-treat (ITT) principle. | Posted | Count of Participants | Participants | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
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| Secondary | Occurrence of Intravenous or Oral Antibiotic Administration | Administration of intravenous or oral antibiotic was collected with concomitant medications, which were coded using WHO-DD Version. A cycle where intravenous or oral antibiotic was administered concurrently was identified by comparing the start and stop dates of each administration of intravenous or oral antibiotic to the start of cycle and end of cycle. The occurrence of intravenous or oral antibiotic administration was at least 1 cycle with intravenous or oral antibiotic administration during the treatment period. | The FAS included all randomized patients who received at least 1 dose of study drug according to the intention-to-treat (ITT) principle. | Posted | Count of Participants | Participants | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
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| Secondary | Occurrence of Infectious Serious Adverse Events | SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect. An infectious SAE was a serious event in the Medical Dictionary for Regulatory Activities (MedDRA) system organ class "infections and infestations" and a preferred term of anal abscess, bacteraemia, bronchitis, candida infection, chronic sinusitis, conjunctivitis, infection, influenza, nasopharyngitis, oral candidiasis, oral herpes, pharyngitis streptococcal, pneumonia, pneumonia bacterial, respiratory tract infection, sepsis, skin infection, upper respiratory tract infection, urinary tract infection, urosepsis or viral upper respiratory tract infection. | The FAS included all randomized patients who received at least 1 dose of study drug according to the intention-to-treat (ITT) principle. | Posted | Count of Participants | Participants | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
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| Secondary | Occurrence of Lung Infection SAEs | SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect. A lung infection SAE was a serious event in the MedDRA system organ class "infections and infestations" and a preferred term of bronchitis, influenza, pneumonia, pneumonia bacterial, respiratory tract infection, upper respiratory tract infection or viral upper respiratory tract infection. | The FAS included all randomized patients who received at least 1 dose of study drug according to the intention-to-treat (ITT) principle. | Posted | Count of Participants | Participants | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
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| Secondary | Occurrence of Febrile Neutropenia | Each febrile neutropenia event (as defined by Common Terminology Criteria for Adverse Events [CTCAE]) was captured as an AE. The occurrence of febrile neutropenia was defined as at least 1 febrile neutropenia event during the treatment period. For the treatment period, the total number of febrile neutropenia events was the number of febrile neutropenia events with a unique start date. | The FAS included all randomized patients who received at least 1 dose of study drug according to the intention-to-treat (ITT) principle. | Posted | Count of Participants | Participants | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
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| Secondary | Occurrence of Platelet Transfusion | The occurrence of platelet transfusions was defined as at least 1 cycle with platelet transfusion during the treatment period. For the treatment period, the total number of platelet transfusions was the number of cycles with platelet transfusions. | The FAS included all randomized patients who received at least 1 dose of study drug according to the intention-to-treat (ITT) principle. | Posted | Count of Participants | Participants | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 12 months |
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| Secondary | Objective Tumor Response Rate (ORR) | ORR was performed based on the Response Evaluation Analysis Set (RES). Based on the assessments at each visit, the number and percentage of patients with best response of CR, PR, SD, PD and NE will be summarized by treatment group when CR/PR confirmation is not required and CR/PR confirmation is required, respectively . In particular, SD BOR requires at least 35 days or more after enrollment.ORR was calculated based on the number of patients with best response of CR or PR. | Response Evaluable Analysis Set (RES): all patients who took at least one dose of study drug, had measurable disease at baseline, and completed at least one post-treatment tumor imaging assessment. This analysis set was used for the analysis of anti-tumor efficacy endpoints related to tumor RECIST1.1 assessment. efficacy endpoints related to tumor RECIST1.1 assessment. | Posted | Count of Participants | Participants | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 18 months |
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| Secondary | Disease Control Rate (DCR) | DCR was performed based on the Response Evaluation Analysis Set (RES). Based on the assessments at each visit, the number and percentage of patients with best response of CR, PR, SD, PD and NE will be summarized by treatment group when CR/PR confirmation is not required and CR/PR confirmation is required, respectively . In particular, SD BOR requires at least 35 days or more after enrollment. DCR was calculated based on the number of patients with best response of CR PR or SD. | Response Evaluable Analysis Set (RES): all patients who took at least one dose of study drug, had measurable disease at baseline, and completed at least one post-treatment tumor imaging assessment. This analysis set was used for the analysis of anti-tumor efficacy endpoints related to tumor RECIST1.1 assessment. efficacy endpoints related to tumor RECIST1.1 assessment. | Posted | Count of Participants | Participants | From date of randomization , 21 day treatment cycle to the end of the treatment until (if earlier) disease progression, start of subsequent anticancer treatment, withdrawal of informed consent, or death, acessed up to a maximum of 18 months |
|
Adverse events were monitored from the time of informed consent through the end of the safety follow-up period, initiation of new antineoplastic therapy, or withdrawal from the study, whichever came first, acessed up to a maximum of 18 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part I ( Safety run-in and PK Evaluation); Trilaciclib Group | 12 patients( 6 patients are first line, 6 patients are second or third line) recieved Trilaciclib(240mg/m^2) plus chemotherapy. Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. | 6 | 12 | 4 | 12 | 12 | 12 |
| EG001 | Part II ( Randomized Double-blind, Placebo-controlled ), Trilaciclib Group | 41 patients received trilaciclib(240mg/m^2) plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. | 22 | 41 | 12 | 41 | 41 | 41 |
| EG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. | 28 | 42 | 15 | 42 | 42 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Oxygen saturation decreased | Investigations | Systematic Assessment |
| ||
| acute cardiac failure | Cardiac disorders | Systematic Assessment |
| ||
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypochloraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cerebral infarction | Nervous system disorders | Systematic Assessment |
| ||
| Death | General disorders | Systematic Assessment |
| ||
| Disease progression | General disorders | Systematic Assessment |
| ||
| White blood cell count decreased | Investigations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| White blood cell count decreased | Investigations | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
| ||
| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| Blood lactate dehydrogenase increased | Investigations | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hyperuricaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoproteinaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypercholesterolaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Weight decreased | Investigations | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| pyrexia | General disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| sinus tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| proteinuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypochloraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| hypomagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Increased serum creatinine | Renal and urinary disorders | Systematic Assessment |
| ||
| urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Chest discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Phlebitis | Vascular disorders | Systematic Assessment |
| ||
| Hyperlipidemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Pain in limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Alpha hydroxybutyrate dehydrogenase increased | Investigations | Systematic Assessment |
| ||
| Tricuspid valve insufficiency | Cardiac disorders | Systematic Assessment |
| ||
| Aortic valve insufficiency | Cardiac disorders | Systematic Assessment |
| ||
| Mitral valve insufficiency | Cardiac disorders | Systematic Assessment |
| ||
| Weight increased | Investigations | Systematic Assessment |
| ||
| Venous thrombosis limb | Vascular disorders | Systematic Assessment |
| ||
| Urine occult blood positive | Investigations | Systematic Assessment |
| ||
| Hypoaesthesia | General disorders | Systematic Assessment |
| ||
| Injection site pain | General disorders | Systematic Assessment |
| ||
| Decreased range of motion | General disorders | Systematic Assessment |
| ||
| White blood cell count increased | Investigations | Systematic Assessment |
| ||
| Fibrin D-dimer increased | Investigations | Systematic Assessment |
| ||
| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Troponin T increased | Investigations | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Blood urea increased | Investigations | Systematic Assessment |
| ||
| Blood myoglobin increased | Investigations | Systematic Assessment |
| ||
| Blood creatine phosphokinase MB increased | Investigations | Systematic Assessment |
| ||
| Blood creatine phosphokinase increased | Investigations | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Embolism | Vascular disorders | Systematic Assessment |
| ||
| Electrocardiogram QT prolonged | Investigations | Systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Jiangsu Simcere Pharmaceutical Co., Ltd. | 86-025-85566666 | simcere@simcere.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 16, 2022 | Apr 17, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000708352 | trilaciclib |
| D016190 | Carboplatin |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
41 patients received trilaciclib(240mg/m^2) plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
| OG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
|
|
|
Trilaciclib 240 mg/m^2 in patients in patients with second or third line ES-SCLC receiving topotecan chemotherapy |
|
|
| OG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
|
|
| OG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
|
|
| OG001 | Part II ( Randomized Double-blind, Placebo-controlled ), Trilaciclib Group | 41 patients received trilaciclib(240mg/m^2) plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
| OG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
|
|
| OG001 | Part II ( Randomized Double-blind, Placebo-controlled ), Trilaciclib Group | 41 patients received trilaciclib(240mg/m^2) plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
| OG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
|
|
| OG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
|
|
| OG001 | Part II ( Randomized Double-blind, Placebo-controlled ), Trilaciclib Group | 41 patients received trilaciclib(240mg/m^2) plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
| OG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
|
|
| Part II ( Randomized Double-blind, Placebo-controlled ), Trilaciclib Group |
41 patients received trilaciclib(240mg/m^2) plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
| OG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
|
|
41 patients received trilaciclib(240mg/m^2) plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
| OG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
|
|
| OG001 | Part II ( Randomized Double-blind, Placebo-controlled ), Trilaciclib Group | 41 patients received trilaciclib(240mg/m^2) plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
| OG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
|
|
| OG001 | Part II ( Randomized Double-blind, Placebo-controlled ), Trilaciclib Group | 41 patients received trilaciclib(240mg/m^2) plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
| OG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
|
|
| OG001 | Part II ( Randomized Double-blind, Placebo-controlled ), Trilaciclib Group | 41 patients received trilaciclib(240mg/m^2) plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
| OG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
|
|
41 patients received trilaciclib(240mg/m^2) plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
| OG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
|
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41 patients received trilaciclib(240mg/m^2) plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first.
| OG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
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| OG001 | Part II ( Randomized Double-blind, Placebo-controlled ), Trilaciclib Group | 41 patients received trilaciclib(240mg/m^2) plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
| OG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
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| OG001 | Part II ( Randomized Double-blind, Placebo-controlled ), Trilaciclib Group | 41 patients received trilaciclib(240mg/m^2) plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of Trilaciclib combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received Trilaciclib combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
| OG002 | Part II ( Randomized Double-blind, Placebo-controlled ), Placebo Group | 42 patients received placebo plus chemotherapy Patients with first line ES-SCLC received up to 6 cycles of placebo combined with carboplatin and etoposide or continued treatment until disease progression, intolerability, withdrawal of consent, or investigator termination, whichever came first; patients with second or third line ES-SCLC received placebo combined with topotecan until disease progression, intolerability, withdrawal of consent, or investigator termination of treatment, whichever came first. |
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