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A Clinical Study Evaluating Nivolumab-containing Treatments in Patients With Advanced Non-small Cell Lung Cancer After Failing Previous PD-1/(L)1 Therapy and Chemotherapy | Clinical Trials | Clareo Health

WITHDRAWNPHASE1/PHASE2

A Clinical Study Evaluating Nivolumab-containing Treatments in Patients With Advanced Non-small Cell Lung Cancer After Failing Previous PD-1/(L)1 Therapy and Chemotherapy

A Phase 1/2, Randomized Study Evaluating Multiple Nivolumab Combination Therapies in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy and Anti-PD-1 (L)1 Immunotherapy

NCT04151563•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

This study is for participants with Non-small Cell Lung Cancer that has spread or has reoccurred after failure of Chemotherapy and Immunotherapy

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
•Histologically or cytologically-documented Stage IV A/B non-small cell lung Cancer, stage IIIB/C disease failed concurrent chemoRT.
•ECOG Performance Status of ≤ 1.
•Radiologically-documented disease progression on one anti-PD-1/anti-PD-L1 therapy and one platinum-based doublet regimen given either concurrently or sequentially within 90 days after the last dose of anti-PD-(L)1.
•All participants must have tumor tissue submitted prior to randomization, either a recent archival sample obtained on/after the date of disease progression of the last prior anticancer therapy and within 3 months prior to enrollment, or a fresh biopsy obtained during the screening period.
•Prior toxicities must have resolved to grade ≤1.
•Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test and must not be breastfeeding.
•Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception. In addition, male participants must be willing to refrain from sperm donation during this time and must agree to follow instructions for method(s) of contraception. Azoospermic males are exempt from contraceptive requirements as well as WOCBP who are continuously not heterosexually active, however, a pregnancy test will still be required.

Exclusion Criteria

•Prior treatment with Docetaxel.
•Untreated CNS metastases, carcinomatous meningitis or leptomeningeal metastases.
•Any tumor invading the Superior Vena Cava other blood vessel, GI Tract or Trachea.
•EGFR mutations, ALK translocations, ROS1 translocations which are sensitive to inhibitor therapy.
•History of cerebrovascular accident and coagulation disorders.
•Participants with interstitial lung disease, history of cerebrovascular accident or history of abdominal fistula, gastrointestinal perforation, bowel obstruction, intra-abdominal abscess or grade 3-4 bleeding event within 6 months prior to randomization.
•Known toxicity on prior checkpoint inhibitor treatment.
•Participants who received more than one line of anti- PD-1/PD-L1 treatment.
•Participants who received previous CTLA-4 inhibitor treatment.
•Participants with known BRAF V600E mutation which are sensitive to available targeted inhibitor therapy are excluded.

Locations (23)

Local Institution

Detroit, Michigan, United States

Local Institution

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Distrito Federal, Argentina

Local Institution

Buenos Aires, Distrito Federal, Argentina

Local Institution

Caba, Distrito Federal, Argentina

Local Institution

Capital, Distrito Federal, Argentina

Local Institution

Charleroi, Belgium

Local Institution

Gilly, Belgium

Local Institution

Leuven, Belgium

Local Institution

Copenhagen Ø, Denmark

Key Dates

Start Date

April 15, 2021

Primary Completion Date

December 17, 2023

Completion Date

May 13, 2026

Last Updated

December 19, 2023

Conditions

Carcinoma, Non-small Cell Lung Cancer

Interventions

nivolumab

BIOLOGICAL

ipilimumab

BIOLOGICAL

cabozantinib

DRUG

docetaxel

BIOLOGICAL

ramucirumab

BIOLOGICAL

lucitanib

DRUG

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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: December 19, 2023Data 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.

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