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Non-Small Cell Lung CancerPhase 1NCT05273814

Study of Chemotherapy and PD-1 Inhibitor Combination With Anti-angiogenesis to Treat Elderly Lung Cancer

A Phase 1 study testing Tislelizumab, Pemetrexed and Bevacizumab in people with Non-Small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This single-center, open-label, phaseⅠstudy is to evaluate the efficacy of Tislelizumab in combination with Bevacizumab and Pemetrexed for the first-line treatment of advanced Non-squamous Non-small Cell lung cancer in Elderly Patients Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Tislelizumab, Pemetrexed and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Aug 2022to 1 Feb 2024
Phase
Phase 1
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Subjects who must meet all the following criteria should be selected:
  • Agree to participate in this trial and sign written informed consent form.
  • Male or female, age ≥ 65 years.
  • Expected survival time ≥ 3 months and able to be followed-up.
  • Stage IIIB/IIIC/IV non-squamous NSCLC patients without previous systemic therapy (according to AJCC8th) or patients with stage IIIB/IIIC/IV non-squamous NSCLC who have relapsed after surgery (if adjuvant therapy was administered, more than 6 months of drug discontinuation is required).
  • Without EGFR mutation and ALK and ROS1 fusion genes.
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  • Patients can not receive concurrent chemoradiothrapy after multidisciplinary consultation and discussion.
  • At least one measurable tumor indicator along with a lesion with a maximum diameter of ≥ 1 cm (diagnosed by imaging, e.g., CT, MRI, ECT).
  • ECOG PS 0-1 within 7 days before enrollment.
  • Within 14 days prior to the start of treatment, laboratory results of routine blood, liver and kidney function and hormone levels meet the following criteria: platelets (PLT) ≥ 100 × 109/L, neutrophils (ANC) ≥ 1.5 × 109/L, hemoglobin (HGB) ≥ 90 g/L, aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) (≤ 5 × ULN for liver metastases), alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for liver metastases), total bilirubin (TIBC) ≤ 1.5 × ULN, and alanine aminotransferase (ALT) ≤ 1.5 × ULN. × ULN), alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for liver metastases), total bilirubin (TIBC) ≤ 1.5 × ULN, serum creatinine (CR) ≤ 1.25 × ULN; cortisol and thyroid function are in the normal range.
  • Toxic effects of prior chemotherapy have resolved to grade 1 or less (except alopecia). Subjects must have recovered from toxicity or complications of these interventions if they have received major surgical treatment or > 30Gy of radiation therapy, i.e., they are still eligible for enrollment after 6 months.

Who cannot join

  • Subjects who meet any of the following criteria could not participate in this study:
  • Received bevacizumab and/or pemetrexed within 6 months prior to the first dose of study drug.
  • Other malignant tumors with disease progression or requiring aggressive treatment within 5 years of enrollment. Exceptions included early-stage tumors (carcinoma in situ or stage I tumors) that received radical treatment, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast that received potentially radical treatment.
  • Have had an allogeneic tissue/organ transplant.
  • Participating or have participated in investigational drug therapy within 4 weeks prior to the first dose of the trial.
  • Receiving systemic hormone therapy or are receiving any other form of immunosuppressive therapy (except docetaxel pretreated glucocorticoids) within 14 days prior to the first dose of the experimental treatment.
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  • Received anti-tumor monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or major surgical procedure within 1 month prior to the first use of study drug; received chest radiation therapy greater than 30 Gy within 6 months prior to the first use of study drug; received chest radiation therapy at 30 Gy or less within 1 month prior to the first use of study drug.
  • Prior treatment with other PD-1 antibodies and other immunotherapy targeting PD-1/PD-L1.
  • Active autoimmune disease requiring systemic therapy (e.g., use of disease-relieving drugs, corticosteroids, or immunosuppressants) within the past 2 years Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic therapy.
  • Having congenital or acquired immune deficiency (e.g., HIV-infected patients), active hepatitis B (HBV-DNA ≥ 2.5 x 10^3 copies/ml), or hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the lower limit of detection for the assay).
  • Patients who have received live vaccine within 4 weeks prior to the first administration of study drug are permitted to receive inactivated viral vaccine for seasonal influenza, administered by injection, but not live attenuated influenza vaccine administered via the nose.
  • Patients with known active central nervous system (CNS) metastases and/or cancerous meningitis. Subjects who have had treatment for brain metastases may also participate in this study provided that the subject is stable (no evidence of progression for at least 4 weeks and all neurological symptoms have returned to baseline levels as determined by MRI prior to the first dose), has no evidence of new or expanding brain metastases, and has not used hormone therapy for at least 3 days prior to study dosing.
  • Bleeding tendency, high bleeding risk, or coagulopathy with a history of thrombotic disease within 6 months and/or hemoptysis within 3 months; being treated with full doses of oral and/or parenteral anticoagulants and thrombolytics (prophylactic anticoagulation is allowed); having used aspirin or other non-steroidal anti-inflammatory drugs that inhibit platelet function within 10 days; and CT/MRI imaging showing tumor encapsulation or invasion of the lumen of large blood vessels.
  • Poorly controlled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg) and patients with prior hypertensive crisis and hypertensive encephalopathy; severe cerebrovascular disease.
  • Non-healing wounds, peptic ulcers in active phase, tracheo-esophageal fistulas, gastrointestinal perforations and intra-abdominal abscesses within 6 months.
  • Have an active infection that requires systemic treatment via Intravenous injection.
  • Have mental illness or other condition, such as uncontrolled heart or lung disease, diabetes mellitus, etc., that prevents cooperation with study treatment and monitoring requirements.
  • History of interstitial lung disease.
  • Patients with moderate to heavy smoking need to quit smoking for more than 1 month.
  • Known allergy to any of the components of the study drug.
  • Patients who are regular users of any drug (including "recreational" use) or have recent history (within 1 year) of substance abuse (including alcohol) when signing the informed consent form.
  • Poor compliance and inability to cooperate with the clinical study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

Other trials in China

About this study

Official title: Phase I Clinical Study of Tislelizumab in Combination With Bevacizumab and Pemetrexed for the First-line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer in Elderly Patients

This single-center, open-label, phaseⅠstudy is to evaluate the efficacy of Tislelizumab in combination with Bevacizumab and Pemetrexed for the first-line treatment of advanced Non-squamous Non-small Cell lung cancer in Elderly Patients

Read the detailed description

Patients received Bevacizumab, 7.5mg/kg d1, Pemetrexed, 500mg/m2, d1 and Tislelizumab 200mg, d4, Q3W, for 4 cycles; then Tislelizumab 200mg, d1 Q3w and Bevacizumab 7.5mg/kg d1 Q3W, maintenance treatment for 2 years.

Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • TislelizumabDrug

    Also called PD-1 inhibitor

    Tislelizumab intravenous infusion 200mg d4

  • PemetrexedDrug

    Also called Chemotherapy

    Pemetrexed intravenous infusion 500mg/m2 d1

  • BevacizumabDrug

    Also called Anti-angiogenesis

    Pemetrexed intravenous infusion 7.5mg/kg，d1

Study groups in NCT05273814
Study groupRoleWhat they receive
Tislelizumab+Bevacizumab+PemetrexedExperimentalBevacizumab，7.5mg/kg，d1; Pemetrexed，500mg/m2，d1; Tislelizumab，200mg，d4; Q3W for 4 cycles; Maintenance treatment ： Tislelizumab，200mg，d1; Bevacizumab，7.5mg/kg，d1; Q3W for 2 years
Receives: Drug: Tislelizumab; Drug: Pemetrexed; Drug: Bevacizumab

What is being measured

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

  1. Objective response rate

    ORR was calculated by the percentage of patients with a confirmed complete (CR) or partial response (PR).

    Measured: approximately 2 years

Secondary outcomes (5)

  1. Overall survival

    Time from the first use of the study drug to the death of the subject

    Measured: approximately 3 years

  2. Progression-free survival

    Progression-free survival is defined as the time from the start of treatment to the first documentation of disease progression or death from any cause, whichever occurs first according to RECIST 1.1.

    Measured: approximately 2 years

  3. Duration of response

    Duration of response is defined as the time from the first recording of evidence of CR or PR until disease progression (according to RECIST 1.1) or death from any cause, whichever occurs first

    Measured: approximately 2 years

  4. Health-related quality of life

    Measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Core 30 (EORTC QLQ-C30) as presented in participants-reported outcomes.Scale construct including to assess Global health status/QoL with range from minimum scores 1 as worse outcome and maximum scores 7 as higher values represent a better; Physical functioning, Role functioning, Emotional functioning, Cognitive functioning, Social functioning, Fatigue, Nausea and vomiting, Pain Dyspnoea, Insomnia, Appetite loss, Constipation, Diarrhoea and Financial difficulties with range from maximum scores 4 as worse outcome and from minimum scores 1 as higher values represent a better.

    Measured: approximately 2 years

  5. Safety and tolerance

    Incidence of Treatment-Emergent Adverse Events

    Measured: approximately 2 years

Timeline

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

  1. First posted10 Mar 2022
  2. Study start1 Aug 2022 (estimated)
  3. Primary completion1 Aug 2023 (estimated)
  4. Study completion1 Feb 2024 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05273814
Sponsor's protocol ID
CCICC-005
Status last verified
Jan 2022
First submitted
28 Jan 2022
Last updated
13 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tislelizumab, Pemetrexed and Bevacizumab in people with Non-Small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and 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 11 inclusion and 22 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 Jul 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: approximately 2 years). 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 NCT05273814.

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 Jul 2022.

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