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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiednivolumab and ipilimumab

Plus 4 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 19, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?23 U.S. locations

Locations may change over time.

Who runs it?Bristol-Myers Squibb

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Bristol-Myers Squibb
Interventions being studied: Biological: nivolumab; Biological: ipilimumab; Drug: cabozantinib; Biological: docetaxel; Biological: ramucirumab; Drug: lucitanib

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Immunotherapy→Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.
Other protocol-defined Inclusion/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Local InstitutionDetroit, Michigan
Local InstitutionCiudad Autónoma de Buenos Aires, Buenos Aires
Local InstitutionBuenos Aires, Distrito Federal
Local InstitutionBuenos Aires, Distrito Federal
Local InstitutionCaba, Distrito Federal
Local InstitutionCapital, Distrito Federal
Local InstitutionCharleroi
Local InstitutionGilly
Local InstitutionLeuven
Local InstitutionCopenhagen Ø
Local InstitutionAthens
Local InstitutionNeo Faliro

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 19, 2023. Always confirm current availability with the study team.

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