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

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Carcinoma, Non-small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT04151563

Run by

Bristol-Myers Squibb

People needed

0

Starts

2021-04-15

Expected to finish

2026-05-13

Last updated by the study team

2023-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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/Exclusion criteria apply.

Where it is running

• 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
• Local Institution — Athens, Greece
• Local Institution — Neo Faliro, Greece
• Local Institution — Torreón, Coahuila, Mexico
• Local Institution — Zapopan, Jalisco, Mexico
• Local Institution — Mexico City, Mexico City, Mexico
• Local Institution — Puebla City, Puebla, Mexico
• Local Institution — Amsterdam, Netherlands
• Local Institution — Rotterdam, Netherlands
• Local Institution — Oslo, Norway
• Local Institution — Warsaw, Masovian Voivodeship, Poland
• Local Institution — Krakow, Poland
• Local Institution — Craiova, Romania
• Local Institution — Timișoara, Romania

Full record on ClinicalTrials.gov

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