Can lung cancer patients safely stop immunotherapy after 6 months?

NCT ID NCT03469960

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

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether patients with advanced non-small cell lung cancer (NSCLC) who received initial immunotherapy (nivolumab and ipilimumab) for 6 months could safely stop treatment and be monitored, instead of continuing therapy indefinitely. The study enrolled 265 patients with PD-L1 positive stage IV NSCLC. The goal was to see if stopping treatment was as effective at controlling cancer while reducing side effects and improving quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Nivolumab and Ipilimumab (immunotherapy drugs)
What this could lead to: If successful, this could show that stopping immunotherapy after 6 months is as effective as continuing indefinitely, reducing side effects and improving quality of life.
What could go wrong: This is a completed trial, but results may not apply to all patients. Stopping treatment early could risk disease progression in some individuals.

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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

265 people

The number who actually took part.

Started

May 2018

Finished

Oct 2025

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

18 to 75 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-proven NSCLC (squamous or non-squamous) 3. Stage IV (M1, including M1a pleural involvement) disease (8th classification TNM, UICC 2015) 4. ECOG PS \< 1 5. Weight loss\< 10% in previous 3 months 6. No prior systemic anticancer therapy (including EGFR or ALK inhibitors) given as primary therapy for advanced or metastatic disease. 7. Age≥ 18 years, \<75 years 8. Life expectancy \> 3 months 9. Measurable tumor disease by CT or MRI per RECIST 1.1 criteria 10. Available tumor samples for centralized PD-L1 immunohistochemistry analysis 11. PD-L1 tumor content ≥ 1% and \< 50% tumor cells as assessed locally by the investigator center 12. Adequate biological functions: Creatinine Clearance ≥ 50 mL/min (Cockcroft or MDRD or CKD-epi); neutrophiles ≥ 1500/mm3 ; platelets ≥100 000/mm3 ; Hemoglobin ≥ 9g/dL ; hepatic enzymes \< 3x 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) 13. Women of childbearing potential (WOCBP) and sexually active should use an efficacious contraception method within the 28 days preceding the first dose and during the 6 months following the last dose of treatment. Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. For Male subjects who are sexually active with WOCBP, an efficacious contraception method should be used during the treatment and during the 7 months following the last dose. Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of \< 1% when used consistently and correctly. At a minimum, subjects must agree to the use of two methods of contraception, with one method being highly effective and the other method being either highly effective or less effective. 14. Patient inclusion validated by a multidisciplinary meeting. 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 HER exon 20 insertion (either tissue or plasma cfDNA mutation). 3. Known ALK or ROS1 gene rearrangement as assessed by immunohistochemistry, FISH or NGS sequencing 4. Previous or active cancer within the previous 5 years (except for treated carcinoma in situ of the cervix or basal cell skin cancer). Patients with a prostate adenocarcinoma history within the previous 5 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, without any chemotherapy) 5. Superior vena cava (SVC) syndrome persisting after SVC stenting 6. Thoracic radiotherapy needed at initiation of tumor treatment, except bone palliative radiotherapy on a painful or compressive metastasis, respecting 4 weeks delay between the end of radiotherapy and the beginning of induction immunotherapy treatment 7. Symptomatic untreated brain metastasis (without previous whole brain radiotherapy or stereotactic ablative brain radiotherapy or without surgical resection). At least 4 weeks delay between the end of radiotherapy and the beginning of induction immunotherapy treatment should be respected. Asymptomatic brain metastasis, not needing corticosteroids greater than 10 mg prednisone equivalent daily or mannitol infusions, with no evolution on brain MRI or CT-scan within the previous month are allowed. 8. History of previous primary immunodeficiency, organ transplantation needing an immunosuppressive treatment, any immunosuppressive drug within 28 days before randomization date, or history of severe toxicity (grade 3/4) by immune mechanism linked to another immunotherapy treatment. 9. Systemic treatment with corticosteroids with greater dose than 10 mg prednisone equivalent daily, within 14 days before initiation of the immunotherapy induction. Inhaled, nasal or topic corticosteroids are allowed. 10. History of active autoimmune disease including rheumatoid polyarthritis, Lupus, Wegener disease. Patients with type I diabetes, or hypothyroidism, or immune cutaneous disease (vitiligo, psoriasis, alopecia) not needing any immunosuppressive systemic treatment, are allowed to be included. 11. Active inflammatory intestinal disease (diverticulosis, Crohn disease, Hemorrhagic recto-colitis, coeliac disease) or any serious chronic intestinal disease with uncontrolled diarrhea 12. Active uncontrolled infection including tuberculosis, known acute viral hepatitis B and C according to serological tests. Patients with serological sequelae of cured viral hepatitis are allowed to be included. 13. HIV known infection 14. Living attenuated vaccine received within the 30 previous days 15. Previous treatment with anti-PD-1, anti-PD-L1 or Anti-CTLA4 antibody 16. Previous treatment with chemotherapy 17. General serious condition such as congestive uncontrolled cardiac failure, uncontrolled cardiac arrythmia, uncontrolled ischemic cardiac disease (unstable angina or history of myocardial infarction in the previous 6 months), history or stroke within the 6 previous months 18. Pre-existing lung interstitial disease as assessed by the diagnosis CT-scan.

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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

AP-HP Hopital Tenon - Pneumologie

Paris, 75020, France
AP-HP Hôpital Bichat

Paris, France
Amiens - CHU

Amiens, France
Angers - CHU

Angers, 49000, France
Annecy - CH

Annecy, 74374, France
Argenteuil -CH

Argenteuil, 95100, France
Avignon - CH

Avignon, France
Bordeaux - Polyclinique Nord

Bordeaux, France
Boulogne - Ambroise Paré

Boulogne-Billancourt, France
CH

Cholet, France
CH Chambery

Chambéry, France
CH Lyon Sud - Pneumologie

Lyon, France
CH de Chauny

Chauny, France
CH de Pontoise

Cergy-Pontoise, France
CH de Villefranche - Pneumologie

Villefranche, France
CHRU Grenoble

Grenoble, France
CHRU de Lille

Lille, France
CHRU de Tours

Tours, France
CHU Nîmes

Nîmes, France
CHU Toulouse

Toulouse, France
CHU de Limoges

Limoges, France
Caen - CHU Côte de Nacre

Caen, 14000, France
Cahors - CH

Cahors, 46000, France
Centre Antoine Lacassagne

Nice, France
Centre Hospitalier - Pneumologie

Le Mans, 72000, France
Centre René Huguenin

Saint-Cloud, France
Clamart - Hôpital Percy

Clamart, 92140, France
Clermont Ferrand - CHU

Clermont-Ferrand, 63000, France
Colmar - CH

Colmar, 68000, France
Dijon - CAC

Dijon, 21000, France
GH Paris Saint-Joseph

Paris, France
HIA Begin

Saint-Mandé, France
Hôpital Saint Louis APHP

Paris, France
ICL Lucien Neuwirth

Saint-Priest-en-Jarez, France
Institut Paoli Calmette

Marseille, France
La Roche Sur Yon - CH

La Roche-sur-Yon, 85925, France
Marseille - Hôpital Européen

Marseille, France
Mont de Marsan - CH

Mont-de-Marsan, 40000, France
Mulhouse - CH

Mulhouse, 68000, France
Nantes - Centre René Gauducheau

Nantes, 44805, France
Orléans - CH

Orléans, 45000, France
Paris - Institut Curie

Paris, France
Rouen - CHU

Rouen, 76000, France
Saint Quentin - CH

Saint-Quentin, 02100, France
Suresnes - Hopital Foch

Suresnes, 92151, France
Toulon - CHI

Toulon, 83000, France
Versailles - CH

Versailles, 78157, France

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