Advanced Squamous Non-Small-Cell Lung CancerPhase 2NCT05900921

Trilaciclib Prior to Chemotherapy Plus Tislelizumab as 1L Treatment for Advanced Squamous Non-Small-Cell Lung Cancer

A Phase 2 study testing Trilaciclib, Carboplatin and Paclitaxel in people with Advanced Squamous Non-Small-Cell Lung Cancer, run by Sichuan University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The purpose of this study is to explore the myeloprotective effects of trilaciclib in advanced squamous non-small cell lung cancer patients receiving a combination therapy of chemotherapy(carboplatin+paclitaxel) and immune checkpoint inhibitor (tislelizumab), as well as enhancing antitumor efficacy and possible… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Squamous Non-Small-Cell Lung Cancer
What is being tested?: Trilaciclib, Carboplatin and Paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 132 participants
Where: No sites listed yet
Study dates: 1 Jul 2023to 31 Dec 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Age ≥ 18 years old and ≤ 75 years old, male or female;
2. Unresectable stage ⅢB and Ⅳ squamous non-small cell lung cancer confirmed by histology or cytology;
3. Have not received systemic anti-tumor therapy for advanced tumors in the past;
4. There is at least one measurable lesion that meets the RECIST1.1 criteria;
5. Patients with asymptomatic brain metastases or stable symptoms after treatment of brain metastases;
6. Laboratory tests meet the following criteria: Hemoglobin ≥ 100 G/L (female), 110 G/L (male) Neutrophil count ≥ 2 × 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); ALT and AST ≤ 3 × ULN or ≤ 5 × ULN (for patients with liver metastases); Albumin ≥ 30g/L;

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7.ECOG PS score 0-1;
8. Expected survival time ≥ 3 months;
9. Women: All women with potential fertility must have negative serum pregnancy test results during the screening period, and must take reliable contraceptive measures from the signing of informed consent to 3 months after the last administration;
10. Understand and sign the informed consent form.

Who cannot join

1. Patients with the following diseases: Known HIV infection, active hepatitis B (defined as HBV DNA positive) and hepatitis C (HCV RNA positive); Interstitial lung disease/lung inflammation; Active, suspected autoimmune disease requiring systemic treatment in the past 2 years;
2. Vaccination of live attenuated vaccine within 4 weeks before enrollment, or expected to require vaccination of live attenuated vaccine during the study period;
3. Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV);
4. Stroke or cardiovascular and cerebrovascular events within 6 months before enrollment 5. QTcF > 480 msec at screening and > 500 msec for patients with ventricular pacemakers
6. Previous hematopoietic stem cell or bone marrow transplantation
7.Hypersensitivity to the study drug or its components;
8. Those who are not considered suitable to participate in the study by the investigator.

Trial locations and contacts

No sites are listed yet.

Yongsheng Wang, professor contact

+86 028-85429455

wangys@scu.edu.cn

About this study

Official title: A Phase II, Randomized, Open-label Trial of Trilaciclib Prior to Chemotherapy Plus Tislelizumab as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer

Read the detailed description

This is a phase 2 clinical trial that is randomized, controlled, multicenter, and prospective in design. A total of 132 patients with advanced, untreated squamous non-small cell lung cancer will be randomly assigned 1:1 to receive or not receive Trilaciclib (240mg/m2) in combination with Paclitaxel (175mg/m2), Cisplatin (AUC=5), and Tislelizumab (200mg) treatment, every 3 weeks for up to 4-6 cycles (Induction). Following induction, patients will receive or not receive trilaciclib with tislelizumab for every 3 weeks until PD, intolerable toxicity, withdrawal, or death. If subsequent chemotherapy is indicated for patients after first-line progression, trilaciclib will be provided to observe the myeloprotective effect in second-line treatment. The study is expected to commence recruitment in mainland China in about May 2023. It is expected that the trial will end in December 2025.

Conditions: Advanced Squamous Non-Small-Cell Lung Cancer
Being tested: Trilaciclib, Carboplatin, Paclitaxel, Tislelizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TrilaciclibDrug
IV infusion, d1
CarboplatinDrug
IV infusion, d1
PaclitaxelDrug
IV infusion, d1
TislelizumabDrug
IV infusion, d1

Study groups in NCT05900921
Study group	Role	What they receive
Experimental: Trilaciclib+Chemotherpy+Tislelizumab	Experimental	Participants received Trilaciclib (240mg/m2) in combination with Paclitaxel (175mg/m2), Cisplatin (AUC=5), and Tislelizumab (200mg) treatment, every 3 weeks for up to 4-6 cycles (Induction). Following induction, patients will receive trilaciclib with tislelizumab for every 3 weeks Receives: Drug: Trilaciclib; Drug: Carboplatin; Drug: Paclitaxel; Drug: Tislelizumab
Active Comparator: Chemotherpy+Tislelizumab	Active comparator	Participants received Paclitaxel (175mg/m2), Cisplatin (AUC=5), and Tislelizumab (200mg) treatment, every 3 weeks for up to 4-6 cycles (Induction). Following induction, patients will receive tislelizumab for every 3 weeks until PD Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

incidence of grade ≥3 Neutrophil count decreased
The " incidence " is defined as the proportion of subjects from randomization to 15 days after the end of first-line chemotherapy treatment in which the events occurred. The occurrence of Grade 3 Neutrophil count decreased was a binary variable. If a patient had at least 1 absolute neutrophil count value <1 × 10^9/L during the Induction Period, the patient was assigned as Yes to the occurrence of SN; otherwise, it was No.
Measured: Induction Period，From date of randomization, 21 day treatment cycles up to a maximum of 4-6 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator

Secondary outcomes (7)

1. incidence of other indicators of Myelosuppression(Grade 4 Neutrophil count decreased, grade 3 or 4 thrombocytopenia, grade 3 or 4 anemia, febrile neutropenia)
The criterion for identifying any indicator of myelosuppression was if the preferred term for an adverse event was "event" according CTCAE 5.0 criteria. Any occurrence of an event during the induction treatment period is defined as a binary variable (Yes or No); Yes if total number of events ≥ 1 is observed, No for other scenarios. Each event with a unique start date during the induction treatment period was defined as a separate event
Measured: Induction Period，From date of randomization, 21 day treatment cycles up to a maximum of 4-6 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator
Usage rate of Supportive Intervention(Granulocyte colony-stimulating factor (G-CSF), platelet transfusion, red blood cell transfusion (week 5 and later), erythropoietin (ESA), iron, recombinant human interleukin-11, and/or thrombopoietin (TPO))
Any occurrence of the event during the induction treatment period was defined as a binary variable (Yes or No); Yes if total number of the event ≥ 1 is observed, No for other scenarios. If the patient did not have an event, the value of 0 was assigned to that patient. Each event with a unique start date during the induction treatment period was defined as a separate event.
Measured: Induction Period，From date of randomization, 21 day treatment cycles up to a maximum of 4-6 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator
Progress free survival (PFS)
PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
Measured: untill Progressive Disease(PD) or death(up to 24 months)
Overall Survival (OS)
OS is defined as the time until death due to any cause.
Measured: From randomization until death (up to 24 months)
Objective Response Rate (ORR)
ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Duration of Response (DOR)
DOR was defined as the time from first documented evidence of CR or PR until disease progression as assessed by RECIST 1.1 or death.
Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202331 Dec 2025

First posted13 Jun 2023
Study start1 Jul 2023 (estimated)
Primary completion31 Oct 2024 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Squamous Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Sichuan UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 132 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05900921
Sponsor's protocol ID: SMA-NSCLC-011
Status last verified: Jun 2023
First submitted: 1 Jun 2023
Last updated: 13 Jun 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Yongsheng Wang, professor

+86 028-85429455

wangys@scu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
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All Advanced Squamous Non-Small-Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Open-label Trial of Trilaciclib Prior to Chemotherapy Plus Tislelizumab as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer
ClinicalTrials.gov ID: NCT05900921
Acronym / sponsor ID: SMA-NSCLC-011
Conditions: Advanced Squamous Non-Small-Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 132 participants (estimated)
Lead sponsor: Sichuan UniversityUniversity, hospital or other
Collaborators: Chengdu First People's Hospital, Chengdu Second people's hospital, Chengdu Seventh People's Hospital, Mianyang Central Hospital, Shanxi Province Cancer Hospital, Shandong Cancer Hospital and Institute, Heilongjiang Provicial Hospital, Enshi Central Hospital, Neijiang Hospital of Traditional Chinese Medicine
Study start: 1 Jul 2023 (estimated)
Primary completion: 31 Oct 2024 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 13 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental: Trilaciclib+Chemotherpy+Tislelizumab	Experimental	Drug: Trilaciclib, Drug: Carboplatin, Drug: Paclitaxel, Drug: TislelizumabParticipants received Trilaciclib (240mg/m2) in combination with Paclitaxel (175mg/m2), Cisplatin (AUC=5), and Tislelizumab (200mg) treatment, every 3 weeks for up to 4-6 cycles (Induction). Following induction, patients will receive trilaciclib with tislelizumab for every 3 weeks
Active Comparator: Chemotherpy+Tislelizumab	Active comparator	Drug: Carboplatin, Drug: Paclitaxel, Drug: TislelizumabParticipants received Paclitaxel (175mg/m2), Cisplatin (AUC=5), and Tislelizumab (200mg) treatment, every 3 weeks for up to 4-6 cycles (Induction). Following induction, patients will receive tislelizumab for every 3 weeks until PD

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

1. Age ≥ 18 years old and ≤ 75 years old, male or female;
2. Unresectable stage ⅢB and Ⅳ squamous non-small cell lung cancer confirmed by histology or cytology;
3. Have not received systemic anti-tumor therapy for advanced tumors in the past;
4. There is at least one measurable lesion that meets the RECIST1.1 criteria;
5. Patients with asymptomatic brain metastases or stable symptoms after treatment of brain metastases;

Key exclusion criteria (7 listed)

1. Patients with the following diseases: Known HIV infection, active hepatitis B (defined as HBV DNA positive) and hepatitis C (HCV RNA positive); Interstitial lung disease/lung inflammation; Active, suspected autoimmune disease requiring systemic treatment in the past 2 years;
2. Vaccination of live attenuated vaccine within 4 weeks before enrollment, or expected to require vaccination of live attenuated vaccine during the study period;
3. Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV);
4. Stroke or cardiovascular and cerebrovascular events within 6 months before enrollment 5. QTcF > 480 msec at screening and > 500 msec for patients with ventricular pacemakers
6. Previous hematopoietic stem cell or bone marrow transplantation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TrilaciclibIV infusion, d1	Drug	Experimental: Trilaciclib+Chemotherpy+Tislelizumab
CarboplatinIV infusion, d1	Drug	Active Comparator: Chemotherpy+Tislelizumab, Experimental: Trilaciclib+Chemotherpy+Tislelizumab
PaclitaxelIV infusion, d1	Drug	Active Comparator: Chemotherpy+Tislelizumab, Experimental: Trilaciclib+Chemotherpy+Tislelizumab
TislelizumabIV infusion, d1	Drug	Active Comparator: Chemotherpy+Tislelizumab, Experimental: Trilaciclib+Chemotherpy+Tislelizumab

Primary outcome

incidence of grade ≥3 Neutrophil count decreased
Time frame: Induction Period，From date of randomization, 21 day treatment cycles up to a maximum of 4-6 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator
The " incidence " is defined as the proportion of subjects from randomization to 15 days after the end of first-line chemotherapy treatment in which the events occurred. The occurrence of Grade 3 Neutrophil count decreased was a binary variable. If a patient had at least 1 absolute neutrophil count value <1 × 10^9/L during the Induction Period, the patient was assigned as Yes to the occurrence of SN; otherwise, it was No.

7 secondary outcomes

1. incidence of other indicators of Myelosuppression(Grade 4 Neutrophil count decreased, grade 3 or 4 thrombocytopenia, grade 3 or 4 anemia, febrile neutropenia)
Time frame: Induction Period，From date of randomization, 21 day treatment cycles up to a maximum of 4-6 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator
Usage rate of Supportive Intervention(Granulocyte colony-stimulating factor (G-CSF), platelet transfusion, red blood cell transfusion (week 5 and later), erythropoietin (ESA), iron, recombinant human interleukin-11, and/or thrombopoietin (TPO))
Time frame: Induction Period，From date of randomization, 21 day treatment cycles up to a maximum of 4-6 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator
Progress free survival (PFS)
Time frame: untill Progressive Disease(PD) or death(up to 24 months)
Overall Survival (OS)
Time frame: From randomization until death (up to 24 months)
Objective Response Rate (ORR)
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Duration of Response (DOR)
Time frame: Up to approximately 24 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.

Related trials for Advanced Squamous Non-Small-Cell Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
Active, not recruitingPhase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
Non-small Cell Lung Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yongsheng Wang, professor contact

+86 028-85429455

wangys@scu.edu.cn

Yongsheng Wang principal investigator

West China Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trilaciclib, Carboplatin and Paclitaxel in people with Advanced Squamous Non-Small-Cell Lung Cancer, run by Sichuan University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yongsheng Wang, professor (+86 028-85429455, wangys@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of grade ≥3 Neutrophil count decreased (time frame: Induction Period，From date of randomization, 21 day treatment cycles up to a maximum of 4-6 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05900921.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.