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

NCT05273814 | Unknown Phase 1

• 1 other identifier: CCICC-005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

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

  approximately 2 years

Secondary Outcomes (5)

• Overall survival

  approximately 3 years

• Progression-free survival

  approximately 2 years

• Duration of response

  approximately 2 years

• Health-related quality of life

  approximately 2 years

• Safety and tolerance

  approximately 2 years

Study Arms (1)

Tislelizumab+Bevacizumab+Pemetrexed

EXPERIMENTAL

Bevacizumab，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

Drug: Tislelizumab; Drug: Pemetrexed; Drug: Bevacizumab

Interventions

Tislelizumab DRUG

Tislelizumab intravenous infusion 200mg d4

Also known as: PD-1 inhibitor

Tislelizumab+Bevacizumab+Pemetrexed

Pemetrexed DRUG

Pemetrexed intravenous infusion 500mg/m2 d1

Also known as: Chemotherapy

Tislelizumab+Bevacizumab+Pemetrexed

Bevacizumab DRUG

Pemetrexed intravenous infusion 7.5mg/kg，d1

Also known as: Anti-angiogenesis

Tislelizumab+Bevacizumab+Pemetrexed

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

tislelizumab; Immune Checkpoint Inhibitors; Pemetrexed; Drug Therapy; Bevacizumab; Angiogenesis Inhibitors

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: March 10, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: February 1, 2024
• Last Updated: July 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)