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Hope for elderly lung cancer patients: immunotherapy combo under study

NCT ID NCT03977194

Disease control Sponsor: Intergroupe Francophone de Cancerologie Thoracique Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether adding the immunotherapy drug atezolizumab to standard chemotherapy helps elderly patients (70+) with advanced non-small cell lung cancer live longer. About 510 participants will receive either chemotherapy alone or chemotherapy plus atezolizumab. The goal is to see if this combination is both effective and safe for older adults, who are often underrepresented in cancer trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

510 people

The number who actually took part.

Started

Jul 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

70 to 89 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. The radiological assessment has to be done within the timelines indicated. 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. 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 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, 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, including but not limited to unstable angina or uncontrolled cardiac disease. 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

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non small cell lung cancer metastatic

Contacts and locations

Locations

  • Abbeville - CH

    Abbeville, 80142, France

  • Aix-en-Provence - CH

    Aix-en-Provence, France

  • Annemasse - CH

    Ambilly, 74100, France

  • Auxerre - CH

    Auxerre, 89011, France

  • Avignon - CH

    Avignon, France

  • Avignon - Institut Sainte-Catherine

    Avignon, 84918, 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 Mémorial de Saint-Lô

    Saint-Lô, 50000, France

  • Centre Hospitalier de Chambéry

    Chambéry, 73000, France

  • Centre Hospitalier des Pays de Morlaix

    Morlaix, 29600, 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

  • La Réunion - CHU (Site Sud)

    Saint-Pierre, 97448, France

  • La Réunion - CHU (site Félix GUYON)

    Saint-Denis, 97400, 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

  • Lyon - URCOT

    Pierre-Bénite, France

  • Marseille - AP-HM Hôpital Nord

    Marseille, France

  • Marseille - Hôpital Européen

    Marseille, France

  • Marseille - Institut Paoli Calmette

    Marseille, France

  • Meaux - CH

    Meaux, 77100, France

  • Metz - Thionville CHR

    Ars-Laquenexy, 57530, France

  • Montauban - CH

    Montauban, 82000, 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 - APHP - Hopital Tenon

    Paris, 75020, France

  • Paris - APHP Bichat

    Paris, France

  • Paris - Curie

    Paris, France

  • Paris - Hôpital Cochin

    Paris, France

  • Paris - Hôpital Saint Joseph

    Paris, 75014, France

  • Pau - CHG

    Pau, France

  • Quint-Fonsegrives - Clinique de la Croix du Sud

    Quint-Fonsegrives, France

  • Rodez - CH

    Rodez, 12021, France

  • Saint- Mandé - HIA Begin

    Saint-Mandé, France

  • Saint-Cloud - Centre René Huguenin

    Saint-Cloud, 92210, France

  • Saint-Etienne - CHU

    Saint-Etienne, 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

More trials for these conditions

Other studies related to the condition(s) this trial covers.