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

Conditions

• Carcinoma, Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• nivolumab — BIOLOGICAL
  Specified dose on Specified days
• ipilimumab — BIOLOGICAL
  Specified dose on Specified days
• cabozantinib — DRUG
  Specified dose on Specified days
• docetaxel — BIOLOGICAL
  Specified dose on Specified days
• ramucirumab — BIOLOGICAL
  Specified dose on Specified days
• lucitanib — DRUG
  Specified dose on Specified days

Study Details

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

Key Dates

Start date

Apr 15, 2021

Status verified

Dec 2023

Primary completion

Dec 17, 2023

Completion

May 13, 2026

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: cabozantinib + nivolumab + ipilimumab
• Experimental: Arm B: cabozantinib + nivolumab
• Experimental: Arm C: nivolumab + ramucirumab + docetaxel
• Experimental: Arm D: lucitanib + nivolumab
• Experimental: Arm E: nivolumab + docetaxel
• Active Comparator: Arm F: docetaxel

Primary Outcome Measure

Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment [ Time Frame: approximately 33 months ]

Locations (1)

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