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Non Small Cell Lung Cancer MetastaticPhase 3ELDERLYNCT03977194

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

A Phase 3 study testing Carboplatin, Paclitaxel and Atezolizumab in people with Non Small Cell Lung Cancer Metastatic, run by Intergroupe Francophone de Cancerologie Thoracique at 68 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 70 to 89 years
Conditions the study is for
Non Small Cell Lung Cancer Metastatic
What is being tested?
Carboplatin, Paclitaxel and Atezolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
510 participants
Where
68 sitesFrance
Study dates
23 Jul 2019to Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 to 89 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.
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  • 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.
  • 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.

Who cannot join

  • 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.
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  • 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)
  • Symptomatic brain metastases requiring corticosteroids.
  • Spinal cord compression not definitely treated by surgery and/or radiation therapy or with neurological sequelae.
  • Leptomeningeal disease
  • Uncontrolled tumor-related pain.
  • Uncontrolled or symptomatic or requiring Denosumab hypercalcemia .
  • Corticosteroids > 10mg oral prednisone/day or equivalent.
  • 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.
  • 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, 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

Trial locations and contacts

68 sites in 1 country.

68 sites in 1 country

France68 sites

  • Abbeville - CH

    Abbeville, 80142

  • Aix-en-Provence - CH

    Aix-en-Provence

  • Annemasse - CH

    Ambilly, 74100

  • Metz - Thionville CHR

    Ars-Laquenexy, 57530

  • Auxerre - CH

    Auxerre, 89011

  • Avignon - Institut Sainte-Catherine

    Avignon, 84918

  • Avignon - CH

    Avignon

  • Bayonne - CH

    Bayonne

  • Besançon - CHU

    Besançon

  • Bobigny - APHP - Hôpital Avicenne

    Bobigny

  • Bordeaux - CHU Hôpital Haut-Lévèque

    Bordeaux

  • Bordeaux - Polyclinique Nord

    Bordeaux

  • Boulogne - Ambroise Paré

    Boulogne-Billancourt

  • Caen - CHU Côte de Nacre

    Caen, 14000

  • Cannes - CH

    Cannes

  • Carcassone - CH

    Carcassonne

  • Centre Hospitalier de Chambéry

    Chambéry, 73000

  • Chauny - Centre Hospitalier

    Chauny

  • Cholet - CH

    Cholet

  • Clamart - Hôpital Percy

    Clamart, 92140

  • Clermont Ferrand - CHU

    Clermont-Ferrand, 63000

  • Colmar - CH

    Colmar

  • Cornebarrieu - Clinique des Cèdres

    Cornebarrieu

  • Dijon - Centre Georges-François Leclerc

    Dijon, 21000

  • Grenoble - CHU

    Grenoble

  • Le Mans - CHG

    Le Mans

  • Lille - GHICL

    Lille, 59020

  • Lille - Polyclinique de la Louvière

    Lille

  • Limoges - CHU

    Limoges

  • Lorient - CHBS

    Lorient

  • Lyon - Hôpital Jean Mermoz

    Lyon

  • Marseille - AP-HM Hôpital Nord

    Marseille

  • Marseille - Hôpital Européen

    Marseille

  • Marseille - Institut Paoli Calmette

    Marseille

  • Meaux - CH

    Meaux, 77100

  • Montauban - CH

    Montauban, 82000

  • Centre Hospitalier des Pays de Morlaix

    Morlaix, 29600

  • Mulhouse - GHRMSA

    Mulhouse

  • Nancy - Institut de Cancérologie de Lorraine

    Nancy

  • Nantes - CHU Hôpital Laënnec

    Nantes

  • Nice - CRLCC

    Nice, 06189

  • Orléans - CH

    Orléans, 45000

  • Paris - Hôpital Saint Joseph

    Paris, 75014

  • Paris - APHP - Hopital Tenon

    Paris, 75020

  • Paris - APHP Bichat

    Paris

  • Paris - Curie

    Paris

  • Paris - Hôpital Cochin

    Paris

  • Pau - CHG

    Pau

  • Lyon - URCOT

    Pierre-Bénite

  • Quint-Fonsegrives - Clinique de la Croix du Sud

    Quint-Fonsegrives

  • Rodez - CH

    Rodez, 12021

  • Saint-Cloud - Centre René Huguenin

    Saint-Cloud, 92210

  • La Réunion - CHU (site Félix GUYON)

    Saint-Denis, 97400

  • Saint-Etienne - CHU

    Saint-Etienne

  • Centre Hospitalier Mémorial de Saint-Lô

    Saint-Lô, 50000

  • Saint- Mandé - HIA Begin

    Saint-Mandé

  • La Réunion - CHU (Site Sud)

    Saint-Pierre, 97448

  • Saint-Priest - Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez, 42271

  • Sens - CH

    Sens, 89100

  • Strasbourg - Nouvel Hôpital Civil

    Strasbourg, 67091

  • Suresnes - Hopital Foch

    Suresnes, 92151

  • Toulon - CHI

    Toulon, 83000

  • Toulon - HIA

    Toulon, 83000

  • Toulouse - CHU

    Toulouse

  • Tours - CHU

    Tours, 37000

  • Valence - CH

    Valence, 26953

  • Valenciennes - Clinique

    Valenciennes, 59304

  • Villefranche-Sur-Saône - Hôpital Nord-Ouest

    Villefranche-sur-Saône

Other trials in France

About this study

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

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.

Keywords
IFCT, ELDERLY, NSCLC, immunotherapy, chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03977194
Study groupRoleWhat they receive
Arm A : standard treatmentActive comparatorCarboplatine + paclitaxel (4 cycles of 28 days)
Receives: Drug: Carboplatin; Drug: Paclitaxel
Arm B : standard treatment + immunotherapyExperimentalCarboplatine + paclitaxel (4 cycles of 28 days) + atezolizumab (every 21 days) until progression or toxicity
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Time from randomization until death due to any cause

    Measured: 11 months after randomization of the last subject

Secondary outcomes (3)

  1. Progression-free survival

    Time from randomization to first observation of progression (according to RECIST v1.1) or date of death (from any cause).

    Measured: 11 months after randomization of the last subject

  2. Best overall response rate

    Best response according to RECIST v1.1 from start to end of study treatment

    Measured: 11 months after randomization of the last subject

  3. Duration of response

    Time from documentation of tumor response to disease progression

    Measured: 11 months after randomization of the last subject

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2019
  2. Study start23 Jul 2019
  3. Primary completion31 Aug 2024
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
510 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03977194
Sponsor's protocol ID
IFCT-1805
Acronym
ELDERLY
Status last verified
Nov 2025
First submitted
5 Jun 2019
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 21831418

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carboplatin, Paclitaxel and Atezolizumab in people with Non Small Cell Lung Cancer Metastatic, run by Intergroupe Francophone de Cancerologie Thoracique at 68 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 11 months after randomization of the last subject). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03977194, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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