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

  • STATUS
    Recruiting
  • End date
    Apr 26, 2023
  • participants needed
    500
  • sponsor
    Intergroupe Francophone de Cancerologie Thoracique
Updated on 26 January 2021

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 on26 January 2021

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 has been prepared
Age: 70 to 89 years
Performance status 1
Stage IIIB or IIIC non irradiable or IV (8th classification TNM, UICC 2015)
Measurable disease as defined by RECIST 1.1
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
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
mm3 ; platelets 100 000/mm3 ; Hemoglobin 9g/dL ; hepatic enzymes < 3x 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
Oral contraception should always be combined with an additional contraceptive
method because of a potential interaction with the treatment. Male patients
must always use a condom
\. Patient covered by a national health insurance
\. Protected adults can participate if they are able to make decision about
their medical treatment according to guardianship judgment

Exclusion Criteria

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
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)
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
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, Sjgren's syndrome, Guillain-Barr 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
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
would be excluded) are permitted provided that they meet the following
conditions
Rash must cover less than 10% of body surface area (BSA)
Disease is well controlled at baseline and only requiring low potency topical steroids
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) 10. Symptomatic brain metastases requiring corticosteroids. 11. Spinal cord compression not definitely treated by surgery and/or radiation therapy or with neurological sequelae. 12. Leptomeningeal disease 13. Uncontrolled tumor-related pain. 14. Uncontrolled or symptomatic or requiring Denosumab hypercalcemia . 15. Corticosteroids > 10mg oral prednisone/day or equivalent. 16. Immunosuppressive medications within 2 weeks before randomization 17. 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. 18. HIV positive serology (test at screening), 19. 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
Patients positive for hepatitis C virus (HCV) antibody are eligible only if
PCR is negative for HCV RNA
\. 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
\. 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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