AzTrials
AzTrials

Advanced Non-squamous Non-Small-Cell Lung CancerPhase 3SPBPDCNCT05648071

First-Line Treatment for Advanced Non-squamous Non-Small-Cell Lung Cancer With Negative Driver Gene: a Single-center, Single-Arm Trial

A Phase 3 study testing Sintilimab in people with Advanced Non-squamous Non-Small-Cell Lung Cancer, run by Qianfoshan Hospital at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

To evaluate the efficacy and safety of sintilimab plus bevacizumab and platinum-based doublet chemotherapy as the first-line therapy for advanced nonsquamous non-small-cell lung cancer(NSCLC) with negative driver gene. This study is an exploratory single-arm study. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Sintilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Dec 2021to 1 Jul 2025
Phase
Phase 3
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

  • Metastatic Non-squamous NSCLC is histologically or cytologically proven to be inoperable and cannot receive radical concurrent chemoradiotherapy. The conventional TNM stage was identified as stage IIIa-Ⅳb according to the International Association for the Study of Lung Cancer and the American Joint Committee on the Classification of Cancer 8th edition TNM Staging of Lung Cancer.
  • Patients with driver-negative advanced Non-squamous NSCLC.
  • Patients who had not previously received systemic radiotherapy and chemotherapy or who had relapsed for more than 6 months of follow-up after onset of adjuvant chemotherapy.
  • At least one measurable lesion as determined by RECIST criteria.
  • Male or female patients, age: 18-75 years of age.
  • Performance score 0-1 based on Eastern Cooperative Oncology Group (ECOG) test.
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  • Expected survival period ≥12 weeks.
  • Serum absolute number of neutrophils≥ 1.5 x 10^9/L, platelet ≥ 100 x10^9/L, and hemoglobin≥ 90g/L.
  • Serum bilirubin≤1.5 times ULNL, aspartate aminotransferase (AST) and adenosine triphosphate(ALT) ≤ 2.5 times ULN, alkaline phosphatase ≤ 5 times ULN.
  • Serum creatinine≤ the ULN or creatinine clearance ≥ 60 mL/min.
  • Patients who had previously undergone surgery have recovered for more than 4 weeks from the beginning of the project.
  • Women with an intact uterus must have a negative pregnancy test within 28 days prior to enrolement in the study (unless it was 24 months after amenorrhea). If the pregnancy test is more than 7 days prior to initial dosing, a urine pregnancy test is required for verification (within 7 days prior to initial dosing).
  • If there is a risk of conception, all patients (whether male or female) are required to use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of the study drug.
  • Sign the inform consent form with good compliance.

Who cannot join

  • Those who are known to be allergic to the study drug sintilimab, bevacizumab and and its any components.
  • Intolerance to study drug treatment or allergy to the active ingredients or excipients of combined chemotherapy drugs.
  • Pregnancy or breastfeeding women or women who may be pregnant but are unwilling to take appropriate contraception.
  • Existing severe acute infections that are not under control; Or suppurative and chronic infections with delayed healing.
  • Pre-existing serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina pectoris, myocardial infarction, severe valvular heart disease, and refractory hypertension.
  • People suffering from uncontrollable neuropsychiatric diseases or mental disorders had poor compliance and were unable to cooperate and describe treatment responses; The conditions of patients with primary brain tumor or central nerve metastatic tumor were uncontrollable and the symptoms of cranial hypertension or neuropsychiatric were obvious.
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  • Patients with hereditary bleeding tendency or coagulation dysfunction, or history of thrombosis or bleeding, and abnormal detection results of coagulation function related indicators.
  • Patients who are receiving thrombolytic or anticoagulant therapy due to high risk of thrombosis.
  • Patients with unhealed wounds, unhealed ulcers or unhealed fractures.
  • Other conditions that the investigator considers to be inappropriate for the patient to participate in this trial.
  • Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose.
  • Patients who have undergone major surgery within 4 weeks before the start of study treatment or are scheduled to undergo major surgery during the study period (except for surgery such as puncture or lymph node biopsy).
  • Pulmonary interstitial fibrosis with respiratory failure.
  • Chronic obstructive pulmonary disease with respiratory failure.
  • Active pulmonary tuberculosis;
  • Active autoimmune disease requiring systemic therapy (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (such as thyroxine) is not considered systemic therapy;
  • Those who are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 14 days before the first dose of the study;
  • Have previously received the following therapies: anti-pd1 drugs, anti-PD-L1 drugs.

Trial locations and contacts

1 site in 1 country.

Degan Lu, professor contact

18753157623

deganlu@126.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shandong, 250014

    Degan Lu, professor, 18753157623, deganlu@126.com

    Recruiting

Other trials in China

About this study

Official title: Sintilimab Plus Bevacizumab and Platinum-Based Doublet Chemotherapy as First-Line Treatment for Advanced Non-squamous Non-Small-Cell Lung Cancer With Negative Driver Gene: a Single-center, Single-Arm Trial

To evaluate the efficacy and safety of sintilimab plus bevacizumab and platinum-based doublet chemotherapy as the first-line therapy for advanced nonsquamous non-small-cell lung cancer(NSCLC) with negative driver gene.

This study is an exploratory single-arm study. The specific treatment regimen is as follows: Non-squamous NSCLC: Sintilimab (200 mg) plus Bevacizumab (7.5mg/kg) is started on the first day of each treatment cycle and administered every three weeks. Nedaplatin (80-100 mg/m2) (d2) +pemetrexed 500 mg/m2 (d2) Q3W is administered in this regimen for 4 cycles followed by sintilimab plus bevacizumab until disease progression or intolerable toxicity.

Patients are assessed for measurable disease at baseline, 6 weeks, 12 weeks after starting treatment, and every 9 weeks thereafter according to RECIST 1.1 criteria during the treatment period until disease progression or intolerable toxicity withdrawal. Following discontinuation of treatment, subjects are followed for survival status every 3 months until death. Subject safety was assessed during treatment according to NCI CTCAE Version 4.0 criteria. Subjects who experience an AE should be followed until the AE returns to baseline. The primary endpoints is Progression-free survival (PFS) . Secondary endpoints include objective response rate (ORR), overall survival (OS) and safety (NCI CTCAE v 4.0). Statistical methods: The PFS curve was estimated using the Kaplan-Meier method for the largest population to be analyzed. The confidence interval method was used as the criterion for the main analysis. OS was calculated in the same way as the secondary endpoint. Descriptive statistics will be used to analyze ORR, DCR, etc. It is expected that sintilimab plus bevacizumab and platinum-based doublet chemotherapy as first-line treatment will prolong median PFS and OS in patients with driver gene-negative advanced Non-squamous NSCLC.

Read the detailed description

Lung cancer is the most common cause of cancer mortality worldwide[1]. NSCLC represents more than 80% of lung cancer cases[2], with most having nonsquamous histology[3].Current first-line treatment options in metastatic nonsquamous NSCLC without oncogenic driver alterations include checkpoint inhibitor monotherapy in patients with high programmed death-ligand 1 (PD-L1) expression and checkpoint inhibitor therapy in combination with platinum-doublet chemotherapy with or without bevacizumab[4.5].Despite the available standard-of-care first-line treatments, clinical outcomes have remained suboptimal and additional therapeutic options are needed.

Sintilimab is a recombinant, fully human IgG4 anti-PD-1 monoclonal antibody. Preclinical data have shown that sintilimab has a greater affinity against PD-1 than pembrolizumab or nivolumab[6].In a randomised, double-blind, phase 3 trial, sintilimab plus chemotherapy resulted in significantly longer progression-free survival and overall survival versus chemotherapy alone in patients with treatment-naive NSCLC without EGFR or ALK genomic tumour mutations, with a manageable safety profile[7.8].

Bevacizumab, in addition to its known anti-angiogenic effects, has immunomodulatory effects through inhibition of vascular endothelial growth factor (VEGF), including promotion of dendritic cell maturation; normalisation of the tumour vasculature, which might increase T-cell infiltration; and reprogramming of the tumour microenvironment from being immune suppressive to immune permissive[9.10]. Therefore, reversal of VEGF-mediated immunosuppression by bevacizumab could enhance the antitumour activity of sintilimab.

We aimed to evaluate the efficacy and safety of sintilimab with bevacizumab plus platinum-based doublet chemotherapy for the treatment of patients with driver gene-negative advanced nonsquamous NSCLC.

Objective: To evaluate the efficacy and safety of sintilimab plus bevacizumab and platinum-based doublet chemotherapy as the first-line therapy for advanced nonsquamous non-small-cell lung cancer with negative driver gene.

The research idea starts from the safety and efficacy of sintilimab plus bevacizumab and platinum-based doublet chemotherapy for NSCLC. Under the theoretical perspective of clinical research on cancer treatment, an exploratory single-center single-arm study method is used to perform sintilimab plus bevacizumab and platinum-based doublet chemotherapy regimen for first-line treatment of advanced nonsquamous NSCLC patients with negative driver gene. A database is established for the enrolled case report form, systematic data analysis is performed, and finally the study conclusions of above treatment safety and efficacy are obtained. It is expected that sintilimab plus bevacizumab and platinum-based doublet chemotherapy as first-line treatment will prolong median PFS and OS in patients with driver gene-negative advanced nonsquamous NSCLC.

This study is an exploratory single-arm study. The specific treatment regimen is as follows :Non-squamous NSCLC: Sintilimab (200 mg) plus Bevacizumab (7.5mg/kg) is started on the first day of each treatment cycle and administered every three weeks. Nedaplatin (80-100 mg/m2) (d2) +pemetrexed 500 mg/m2 (d2) Q3W is administered in this regimen for 4 cycles followed by sintilimab plus Bevacizumab until disease progression or intolerable toxicity.

Patients are assessed for measurable disease at baseline, 6 weeks, 12 weeks after starting treatment, and every 9 weeks thereafter according to RECIST1.1 criteria during the treatment period until disease progression or intolerable toxicity withdrawal. Following discontinuation of treatment, subjects are followed for survival status every 3 months until death. Subject safety was assessed during treatment according to NCI CTCAE Version 4.0 criteria. Subjects who experience an AE should be followed until the AE returns to baseline. The primary endpoints is Progression-free survival (PFS) . Secondary endpoints include objective response rate (ORR), overall survival (OS) and safety (NCI CTCAE v 4.0).

Statistical methods: The PFS curve was estimated using the Kaplan-Meier method for the largest population to be analyzed. The confidence interval method was used as the criterion for the main analysis. OS was calculated in the same way as the secondary endpoint. Descriptive statistics will be used to analyze ORR, DCR, etc.

Being tested
Sintilimab
Keywords
Non-squamous Non-Small-Cell Lung Cancer,Sintilimab, Bevacizumab

What participants receive

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

  • SintilimabDrug

    Also called Bevacizumab, Pemetrexed, Nedaplatin

    The specific treatment regimen is as follows :Non-squamous NSCLC: Sintilimab (200 mg) plus Bevacizumab (7.5mg/kg) is started on the first day of each treatment cycle and administered every three weeks. Nedaplatin (80-100 mg/m2) (d2) +pemetrexed 500 mg/m2 (d2) Q3W is administered in this regimen for 4 cycles followed by sintilimab plus Bevacizumab until disease progression or intolerable toxicity.

Study groups in NCT05648071
Study groupRoleWhat they receive
Sintilimab Plus Bevacizumab and Platinum-Based Doublet ChemotherapyExperimentalThe specific treatment regimen is as follows :Non-squamous NSCLC: Sintilimab (200 mg) plus Bevacizumab (7.5mg/kg) is started on the first day of each treatment cycle and administered every three weeks. Nedaplatin (80-100 mg/m2) (d2) +pemetrexed 500 mg/m2 (d2) Q3W is administered in this regimen for 4 cycles followed by sintilimab plus bevacizumab until disease progression or intolerable toxicity.
Receives: Drug: Sintilimab

What is being measured

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

  1. PFS

    Progression-free survival

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Secondary outcomes (3)

  1. OS

    overall survival

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

  2. ORR

    objective response rate

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

  3. DOR

    Duration of Responst

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Timeline

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

  1. First posted13 Dec 2022
  2. Study start1 Dec 2021
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05648071
Sponsor's protocol ID
YXLL-KY-2022(036)
Acronym
SPBPDC
Status last verified
Dec 2022
First submitted
4 Dec 2022
Last updated
13 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sintilimab in people with Advanced Non-squamous Non-Small-Cell Lung Cancer, run by Qianfoshan Hospital at 1 site in China.

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 14 inclusion and 18 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 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Degan Lu, professor (18753157623, deganlu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months). 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 NCT05648071, which also lists 10 linked publications.

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 Dec 2022.

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