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Trial record 2 of 5 for:    elderly | intergroupe francophone [Lead] | France

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

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ClinicalTrials.gov Identifier: NCT03977194
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique

Brief 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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Metastatic Drug: Carboplatin Drug: Paclitaxel Drug: Atezolizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Trial of Atezolizumab in Elderly Patients With Advanced Non-Small-Cell Lung Cancer and Receiving Monthly Carboplatin With Weekly Paclitaxel Chemotherapy
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Active Comparator: Arm A : standard treatment
Carboplatine + paclitaxel (4 cycles of 28 days)
Drug: Carboplatin
AUC 6 every 4 weeks

Drug: Paclitaxel
90 mg/m² D1, 8, 15, every 4 weeks

Experimental: Arm B : standard treatment + immunotherapy
Carboplatine + paclitaxel (4 cycles of 28 days) + atezolizumab (every 21 days) until progression or toxicity
Drug: Carboplatin
AUC 6 every 4 weeks

Drug: Paclitaxel
90 mg/m² D1, 8, 15, every 4 weeks

Drug: Atezolizumab
1200 mg every 3 weeks




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 11 months after randomization of the last subject ]
    Time from randomization until death due to any cause


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 11 months after randomization of the last subject ]
    Time from randomization to first observation of progression (according to RECIST v1.1) or date of death (from any cause).

  2. Best overall response rate [ Time Frame: 11 months after randomization of the last subject ]
    Best response according to RECIST v1.1 from start to end of study treatment

  3. Duration of response [ Time Frame: 11 months after randomization of the last subject ]
    Time from documentation of tumor response to disease progression



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 89 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Histologically confirmed NSCLC. A cytologically-proven NSCLC is allowed if a cytoblock has been prepared.
  3. Age: 70 to 89 years
  4. Performance status ≤1.
  5. Stage IIIB or IIIC non irradiable or IV (8th classification TNM, UICC 2015)
  6. Measurable disease as defined by RECIST 1.1
  7. 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.
  8. At least 3 weeks must have elapsed after major surgery or radiation therapy
  9. 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 < 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).

  10. Life expectancy of at least 12 weeks
  11. 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.

  12. Patient covered by a national health insurance
  13. Protected adults can participate if they are able to make decision about their medical treatment according to guardianship judgment.

Exclusion Criteria:

  1. Small cell lung cancer or tumors with mixt histology including a SCLC component
  2. Known EGFR activating tumor mutation (deletion LREA in exon 19, L858R ou L861X mutations in exon 21, G719A/S mutation in exon 18) or HER2 exon 20 insertion (either tissue or plasma cfDNA mutation).
  3. Known ALK or ROS1 gene rearrangement as assessed by IH, FISH or NGS sequencing
  4. 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 or squamous 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)
  5. Mini Mental Score < 24
  6. Previous systemic treatment (including but not limited to chemotherapy, targeted treatment or immunotherapy) except for adjuvant therapy given more than 5 years ago.
  7. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  8. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  9. 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.

    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 (e.g., bronchiolitis obliterans, COPD), 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.

  20. Active tuberculosis
  21. Severe infection within 4 weeks before randomization
  22. Received therapeutic oral or iv antibiotics within 2 weeks before randomization.
  23. Administration of live attenuated vaccine within four weeks before randomization or anticipation that such a live attenuated vaccine will be required during the study.
  24. Serious undergoing diseases or comorbidities precluding the possibility for the patient to receive the treatments.
  25. Polyneuropathy ≥ grade 2 CTC
  26. Treatment with an investigational drug during the 4 weeks preceding inclusion in the trial.
  27. Known allergy to Cremophor EL

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03977194


  Show 65 Study Locations
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Investigators
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Study Chair: Elisabeth QUOIX Strasbourg - NHC
Study Chair: Céline MASCAUX Strasbourg - NHC

Additional Information:
Publications:
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Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT03977194     History of Changes
Other Study ID Numbers: IFCT-1805
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
IFCT
ELDERLY
NSCLC
immunotherapy
chemotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs