Loading clinical trials...

Double Immune Checkpoint Inhibitors in PD-L1-positive Stage IV Non-small Lung CancEr | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Double Immune Checkpoint Inhibitors in PD-L1-positive Stage IV Non-small Lung CancEr

A Randomized Phase 3 Trial Comparing Continuation Nivolumab-Ipilimumab Doublet Immunotherapy Until Progression Versus Observation in Treatment-naive Patients With PDL1-positive Stage IV Non-Small Cell Lung Cancer (NSCLC) After Nivolumab-Ipilimumab Induction Treatment

NCT03469960•Intergroupe Francophone de Cancerologie Thoracique

View on ClinicalTrials.gov

Summary

Non Small Cell lung cancer (NSCLC) remains the first cause of death by cancer in the World. For the patients presenting a NSCLC stage IV, the median of survival is about 15 months today. The chemotherapy with platinum is the standard treatment for these patients but immunotherapy showed these efficacy in 1st line for patients PD-L1 positive. On the other hand, the duration of treatment by immunotherapy is not clear. Indeed, prolonged responses and long survivals have been described in patients having interrupted the treatment. In the melanoma, a treatment of 6 months of ipilimumab demonstrated its efficacy. The objective of the study is to demonstrate that a treatment of 6 months followed by an observation (stop and go) is not less effective than a treatment given until progression or toxicity. This strategy would allow to decrease the accumulated toxicities, to improve the quality of life of the patients and to decrease the costs.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 more criteria

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.
+8 more criteria

Locations (47)

Amiens - CHU

Amiens, France

Angers - CHU

Angers, France

Annecy - CH

Annecy, France

Argenteuil -CH

Argenteuil, France

Avignon - CH

Avignon, France

Bordeaux - Polyclinique Nord

Bordeaux, France

Boulogne - Ambroise Paré

Boulogne-Billancourt, France

Caen - CHU Côte de Nacre

Caen, France

Cahors - CH

Cahors, France

CH de Pontoise

Cergy-Pontoise, France

Key Dates

Start Date

May 2, 2018

Primary Completion Date

November 8, 2023

Completion Date

October 15, 2025

Last Updated

November 18, 2025

Enrollment

265

ACTUAL participants

Conditions

Non-Small Cell Lung Cancer Metastatic

Interventions

Ipilimumab

DRUG

Nivolumab

DRUG

Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer

NCT07250477

Non-small Cell Lung Cancer Stage IIICNon-small Cell Lung Cancer Stage IV+3 more

View study

RECRUITINGPHASE2

Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations

NCT06517953

Non-small Cell Lung Cancer MetastaticEGFR G719X+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Double Immune Checkpoint Inhibitors in PD-L1-positive Stage IV Non-small Lung CancEr

Inclusion Criteria

Exclusion Criteria

Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer

Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations

An Exploratory Study of Atezolizumab and Bevacizumab in Hepatocellular Carcinoma and Non-Small Cell Lung Cancer With Liver Metastases (INTEGRATE)

Staggered, Chemo-Immunotherapy With Durvalumab, MEDI4736 Pemetrexed & Carboplatin (PC) for Metastatic Non-Squamous NSCLC

Dacomitinib in Lung Cancer With Uncommon EGFR Mutations

Xingbai Ji Formula Combined with Chemotherapy and Sintilimab in Metastatic Multi-Target Mutation-Negative Non-Small Cell Lung Cancer: a Clinical Trial