Atezolizumab in Elderly Patients With Advanced Non-Small-Cell Lung Cancer and Receiving Carboplatin Paclitaxel Chemotherapy
ELDERLY
Phase III Randomized Trial of Atezolizumab in Elderly Patients With Advanced Non-Small-Cell Lung Cancer and Receiving Monthly Carboplatin With Weekly Paclitaxel Chemotherapy
1 other identifier
interventional
510
1 country
68
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2019
Longer than P75 for phase_3
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2019
CompletedFirst Posted
Study publicly available on registry
June 6, 2019
CompletedStudy Start
First participant enrolled
July 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedNovember 18, 2025
November 1, 2025
5.1 years
June 5, 2019
November 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Time from randomization until death due to any cause
11 months after randomization of the last subject
Secondary Outcomes (3)
Progression-free survival
11 months after randomization of the last subject
Best overall response rate
11 months after randomization of the last subject
Duration of response
11 months after randomization of the last subject
Study Arms (2)
Arm A : standard treatment
ACTIVE COMPARATORCarboplatine + paclitaxel (4 cycles of 28 days)
Arm B : standard treatment + immunotherapy
EXPERIMENTALCarboplatine + paclitaxel (4 cycles of 28 days) + atezolizumab (every 21 days) until progression or toxicity
Interventions
AUC 6 every 4 weeks
90 mg/m² D1, 8, 15, every 4 weeks
Eligibility Criteria
You may qualify if:
- 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. The radiological assessment has to be done within the timelines indicated.
- 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 ≥ 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).
- 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.
- +2 more criteria
You may not qualify if:
- 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, 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)
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
Abbeville - CH
Abbeville, 80142, France
Aix-en-Provence - CH
Aix-en-Provence, France
Annemasse - CH
Ambilly, 74100, France
Metz - Thionville CHR
Ars-Laquenexy, 57530, France
Auxerre - CH
Auxerre, 89011, France
Avignon - Institut Sainte-Catherine
Avignon, 84918, France
Avignon - CH
Avignon, France
Bayonne - CH
Bayonne, France
Besançon - CHU
Besançon, France
Bobigny - APHP - Hôpital Avicenne
Bobigny, France
Bordeaux - CHU Hôpital Haut-Lévèque
Bordeaux, France
Bordeaux - Polyclinique Nord
Bordeaux, France
Boulogne - Ambroise Paré
Boulogne-Billancourt, France
Caen - CHU Côte de Nacre
Caen, 14000, France
Cannes - CH
Cannes, France
Carcassone - CH
Carcassonne, France
Centre Hospitalier de Chambéry
Chambéry, 73000, France
Chauny - Centre Hospitalier
Chauny, France
Cholet - CH
Cholet, France
Clamart - Hôpital Percy
Clamart, 92140, France
Clermont Ferrand - CHU
Clermont-Ferrand, 63000, France
Colmar - CH
Colmar, France
Cornebarrieu - Clinique des Cèdres
Cornebarrieu, France
Dijon - Centre Georges-François Leclerc
Dijon, 21000, France
Grenoble - CHU
Grenoble, France
Le Mans - CHG
Le Mans, France
Lille - GHICL
Lille, 59020, France
Lille - Polyclinique de la Louvière
Lille, France
Limoges - CHU
Limoges, France
Lorient - CHBS
Lorient, France
Lyon - Hôpital Jean Mermoz
Lyon, France
Marseille - AP-HM Hôpital Nord
Marseille, France
Marseille - Hôpital Européen
Marseille, France
Marseille - Institut Paoli Calmette
Marseille, France
Meaux - CH
Meaux, 77100, France
Montauban - CH
Montauban, 82000, France
Centre Hospitalier des Pays de Morlaix
Morlaix, 29600, France
Mulhouse - GHRMSA
Mulhouse, France
Nancy - Institut de Cancérologie de Lorraine
Nancy, France
Nantes - CHU Hôpital Laënnec
Nantes, France
Nice - CRLCC
Nice, 06189, France
Orléans - CH
Orléans, 45000, France
Paris - Hôpital Saint Joseph
Paris, 75014, France
Paris - APHP - Hopital Tenon
Paris, 75020, France
Paris - APHP Bichat
Paris, France
Paris - Curie
Paris, France
Paris - Hôpital Cochin
Paris, France
Pau - CHG
Pau, France
Lyon - URCOT
Pierre-Bénite, France
Quint-Fonsegrives - Clinique de la Croix du Sud
Quint-Fonsegrives, France
Rodez - CH
Rodez, 12021, France
Saint-Cloud - Centre René Huguenin
Saint-Cloud, 92210, France
La Réunion - CHU (site Félix GUYON)
Saint-Denis, 97400, France
Saint-Etienne - CHU
Saint-Etienne, France
Centre Hospitalier Mémorial de Saint-Lô
Saint-Lô, 50000, France
Saint- Mandé - HIA Begin
Saint-Mandé, France
La Réunion - CHU (Site Sud)
Saint-Pierre, 97448, France
Saint-Priest - Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42271, France
Sens - CH
Sens, 89100, France
Strasbourg - Nouvel Hôpital Civil
Strasbourg, 67091, France
Suresnes - Hopital Foch
Suresnes, 92151, France
Toulon - CHI
Toulon, 83000, France
Toulon - HIA
Toulon, 83000, France
Toulouse - CHU
Toulouse, France
Tours - CHU
Tours, 37000, France
Valence - CH
Valence, 26953, France
Valenciennes - Clinique
Valenciennes, 59304, France
Villefranche-Sur-Saône - Hôpital Nord-Ouest
Villefranche-sur-Saône, France
Related Publications (1)
Quoix E, Zalcman G, Oster JP, Westeel V, Pichon E, Lavole A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Bennouna J, Tredaniel J, Ducolone A, Lebitasy MP, Baudrin L, Laporte S, Milleron B; Intergroupe Francophone de Cancerologie Thoracique. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011 Sep 17;378(9796):1079-88. doi: 10.1016/S0140-6736(11)60780-0. Epub 2011 Aug 8.
PMID: 21831418BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Elisabeth QUOIX
Strasbourg - NHC
- STUDY CHAIR
Céline MASCAUX
Strasbourg - NHC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2019
First Posted
June 6, 2019
Study Start
July 23, 2019
Primary Completion
August 31, 2024
Study Completion (Estimated)
December 1, 2026
Last Updated
November 18, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
The individual participant data underlying the results reported in this article, as well as the study protocol and statistical analysis plan, will be made available after deidentification immediately following publication and for three years. Researchers who provide a methodologically sound proposal for any purpose may direct proposals to contact@ifct.fr. To gain access, data requestors will need to sign a data access agreement that requires approval by the French Cooperative Thoracic Intergroup.