Atezolizumab in Elderly Patients With Advanced Non-Small-Cell Lung Cancer and Receiving Carboplatin Paclitaxel Chemotherapy (ELDERLY)

  • STATUS
    Recruiting
  • End date
    Apr 10, 2023
  • participants needed
    500
  • sponsor
    Intergroupe Francophone de Cancerologie Thoracique
Updated on 10 July 2022

Summary

Non Small Cell Lung Cancer (NSCLC) remains the leading cause of death by cancer in the world. Because of the increase in lung cancer incidence with age and the increase of life expectancy, about half of the patients are patients aged 70 or older. Several clinical trials have shown the interest of adding immunotherapy to standard 1st line chemotherapy in NSCLC. Although in these studies there was not necessarily a higher age limit, in fact the proportion of included patients aged 75 or older remains low (between 7 and 10%). It is therefore necessary to conduct a trial dedicated to these patients in order to determine whether immunotherapy is as effective and tolerated as in the general population.

Details
Condition Non Small Cell Lung Cancer Metastatic
Treatment carboplatin, Paclitaxel, Atezolizumab
Clinical Study IdentifierNCT03977194
SponsorIntergroupe Francophone de Cancerologie Thoracique
Last Modified on10 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed Written Informed Consent
Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care
Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing
Histologically confirmed NSCLC. A cytologically-proven NSCLC is allowed if a cytoblock
Age: 70 to 89 years
has been prepared
Stage IIIB or IIIC non irradiable or IV (8th classification TNM, UICC 2015)
Performance status ≤1
No prior systemic anticancer therapy (including EGFR or ALK inhibitors) given as primary therapy for advanced or metastatic disease. Previously irradiated lesion must not be the only measurable site of disease
Measurable disease as defined by RECIST 1.1. The radiological assessment has to be done within the timelines indicated
At least 3 weeks must have elapsed after major surgery or radiation therapy
Adequate biological functions
Creatinine Clearance ≥ 45 mL/min (Cockcroft or MDRD or CKD-epi); neutrophiles
≥ 1500/mm3 ; platelets ≥100 000/mm3 ; Hemoglobin ≥ 9g/dL ; hepatic enzymes <
x ULN except for patients with hepatic metastases (< 5 x ULN), total
bilirubin ≤ 1,5 x ULN except for patients with proved, Gilbert syndrome (≤ 5 x
ULN) or patients with hepatic metastases (≤ 3,0 mg/dL)
Life expectancy of at least 12 weeks
For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception that results in a low failure rate [< 1% per year] when used consistently and correctly, and to continue its use for 6 months after the last dose of treatment. Male patients should not donate sperm during this study and for at least 6 months after the last dose of treatment
Patient covered by a national health insurance
Oral contraception should always be combined with an additional contraceptive
Protected adults can participate if they are able to make decision about their medical treatment according to guardianship judgment
method because of a potential interaction with the treatment. Male patients
must always use a condom

Exclusion Criteria

Previous or active cancer within the previous 3 years with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal cell skin cancer or ductal carcinoma in situ treated surgically with curative intent. For other type of cancer, please contact IFCT). Patients with a prostate adenocarcinoma history within the previous 3 years could be included in case of localized prostate cancer, with good prognostic factors according to d'Amico classification (≤ T2a and Score de Gleason ≤ 6 and PSA (ng/ml) ≤ 10), provided they were treated in a curative way (surgery or radiotherapy ± hormonotherapy, without any chemotherapy)
Small cell lung cancer or tumors with mixt histology including a SCLC component
Known EGFR activating tumor mutation
Known ALK or ROS1 gene rearrangement as assessed by IH, FISH or NGS sequencing
History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible for this study
Mini Mental Score < 24
Previous systemic treatment (including but not limited to chemotherapy, targeted treatment or immunotherapy) except for adjuvant therapy given more than 5 years ago
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
Patients with rheumatoid arthritis without exacerbation during one year and
with no more than 10 mg oral prednisone /day or equivalent may be included
after rheumatologist advice
Patients with controlled Type 1 diabetes mellitus on a stable dose of insulin
regimen are eligible for this study
Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with
dermatologic manifestations only (e.g., patients with psoriatic arthritis
No acute exacerbations of underlying condition within the previous 12 months (not requiring PUVA [psoralen plus ultraviolet A radiation], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high potency or oral steroids)
would be excluded) are permitted provided that they meet the following
Symptomatic brain metastases requiring corticosteroids
conditions
Spinal cord compression not definitely treated by surgery and/or radiation therapy or with neurological sequelae
Rash must cover less than 10% of body surface area (BSA)
Leptomeningeal disease
Disease is well controlled at baseline and only requiring low potency topical steroids
Uncontrolled tumor-related pain
Uncontrolled or symptomatic or requiring Denosumab hypercalcemia
Patients positive for hepatitis C virus (HCV) antibody are eligible only if
Corticosteroids > 10mg oral prednisone/day or equivalent
PCR is negative for HCV RNA
Immunosuppressive medications within 2 weeks before randomization
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
HIV positive serology (test at screening)
Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen HBsAg test at screening) or hepatitis C Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible only if they are negative for HBV DNA
Active tuberculosis
Severe infection within 4 weeks before randomization
Received therapeutic oral or iv antibiotics within 2 weeks before randomization
Administration of live attenuated vaccine within four weeks before randomization or anticipation that such a live attenuated vaccine will be required during the study
Serious undergoing diseases or comorbidities precluding the possibility for the patient to receive the treatments, including but not limited to unstable angina or uncontrolled cardiac disease
Polyneuropathy ≥ grade 2 CTC
Treatment with an investigational drug during the 4 weeks preceding inclusion in the trial
Known allergy to Cremophor EL
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